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Protocol Library v1 · DRAFT v0

The formulary

All 18 entries, rendered in full: the cannabinoid ratio, the verbatim titration numbers, route and onset, contraindications, interaction flags, the evidence grade, the citations — and, as prominently as the recommendation, what each protocol does not claim.

Evidence grades

A — Systematic review / meta-analysis or RCT-backed (multiple consistent RCTs or consistent SR).
B — Guideline-supported or consistent observational / expert consensus with caveats (e.g. BMJ guideline positioning for third-line use; Delphi consensus).
C — Mechanistic, observational-only, or limited evidence; the recommendation is defensible only as a cautious, titrated trial with explicit stop rules.
DNot established — evidence absent or negative. No entry graded D may be recommended. Grade D appears in the exclusion section only.

Grade D never appears as an available entry. It appears only in what the service refuses. Two entries below carry a D on the indication itself — PT-01 and NV-01 — and both exist as refer-and-screen postures, not as product matches.

Index

Entrycondition_codecondition_labelGrade
EP-01 CP-MSK-01 Chronic musculoskeletal pain after failure of standard therapies (the population Busse 2018 addresses) B
EP-02 CP-NEU-01 Chronic neuropathic pain (peripheral or central) B
EP-03 CP-ARTH-01 Chronic arthritic pain with localized dominant joints BC
EP-04 CP-SLEEP-01 Chronic pain where night-time pain disturbs sleep (sleep addressed as a co-benefit of pain management, NOT as a treated indication) BC
EP-05 CP-GERI-01 Chronic pain in patients ≥65 or on ≥5 concurrent medications B
EP-06 CP-CANC-01 Chronic cancer pain uncontrolled on standard analgesia B
EP-07 CP-OPIOID-01 Chronic pain where cannabinoid trial runs alongside a prescriber-led opioid taper BCD
EP-08 CP-BRKTH-01 Episodic severe breakthrough pain in a patient on a stable oral regimen C
EP-09 CP-MOOD-01 Chronic pain with secondary anxious distress CB
EP-10 CP-POST-01 Chronic pain persisting beyond expected healing after surgery or injury B
EP-11 CP-FIBRO-01 Widespread chronic pain (fibromyalgia-pattern) in a palliative frame C
EP-12 CP-HEP-01 Chronic pain in patients with hepatic impairment or elevated baseline transaminases C
EP-13 CP-TOP-01 Localized musculoskeletal pain where the patient prefers non-systemic products C
SL-01 SLP-CO-01 Sleep disturbance secondary to a condition with graded evidence (typically chronic pain), where night-time symptoms fragment sleep C
SL-02 SLP-HR-01 Medical-card holder already using cannabis nightly for sleep without clinical supervision C
SL-03 ANX-ADJ-01 Sub-syndromal, anxiety-adjacent distress in a cardholder where the certifying practitioner has already authorized a cannabinoid trial C
PT-01 PTSD-SCREEN-01 PTSD presentation in a cardholder D
NV-01 NAU-CINV-01 Chemotherapy-induced nausea/vomiting question from a cardholder BD
EP-01 Grade B

Chronic musculoskeletal pain (non-neuropathic, refractory) — first-line protocol within family

CP-MSK-01

Chronic musculoskeletal pain after failure of standard therapies (the population Busse 2018 addresses)

cannabinoid_ratio

CBD-dominant first, add THC only if goals unmet. Per MacCallum & Russo Delphi routine protocol: start CBD-predominant; add THC only at 40 mg/day CBD if goals unmet. Busse 2018 positions all cannabinoids as third-line, with strong recommendations against first/second-line use. Grade B (expert consensus + guideline positioning; no product-level RCTs exist — memo 03 §1.1).

titration_steps

  1. 01 CBD oral oil: 5 mg CBD twice daily; titrate +10 mg CBD every 2–3 days toward goal, to a ceiling 40 mg/day CBD (MacCallum & Russo Delphi routine; maccallum-delphi.txt).
  2. 02 If goals unmet at 40 mg/day CBD: add THC 1–2.5 mg once daily in the evening; titrate +1–2.5 mg every 2–7 days to max 40 mg/day THC (Busse 2018; Sihota 2021 consensus; clinther-dosing-pubmed.txt).
  3. 03 Reassessment window (5×-half-life rule, derived): dronabinol t½ 25–36 h, 11-OH-THC t½ 44–59 h, CBD t½ 56–61 h (Marinol label; Busse 2018) → judge any increment only after ≥5 days of stable dosing (5 × 61 h ≈ 12.7 days worst-case is the conservative bound; the operational rule is "no increment judged inside 5 days, full steady-state review at ~14 days" — the 5-day figure is memo 03 §3.2's stated practical inference; the 14-day conservative bound is DERIVED, flagged for reviewer).

route + onset_profile

Oral oil default (easier titration, steadier absorption; CAMH App. 5). Onset 30–60 min, peak 2–4 h, bioavailability 6–20% (CAMH; camh-appendix.txt). Inhaled reserved for breakthrough only (see EP-08). Route-first, potency-second.

contraindications

Pregnancy/breastfeeding (noted as standard exclusion in the guideline corpus); uncontrolled psychiatric illness / personal or family history of psychosis (standard cannabinoid-safety exclusion, guideline-tier — flagged for reviewer to confirm against PA rules); hepatic impairment at pharmaceutical-CBD exposure (Epidiolex label requires baseline transaminases; dispensary CBD doses are uncontrolled — the risk cannot be quantified outside pharmaceutical products, memo 03 §4.4).

interaction_flags

clobazam; valproate (with CBD — hepatic); warfarin; tacrolimus/everolimus; buprenorphine; CNS depressants (benzodiazepines, barbiturates, opioids, alcohol, TCAs, antihistamines, lithium); strong CYP3A4/CYP2C19 inducers.

evidence_grade

B

citations

  1. 1. Busse J et al. 2018, BMJ 363:k4069 (medical-cannabis guideline synthesis; small pain reduction, high certainty) — busse-bmj.txt / memo 03 §1.1, §2.2.
  2. 2. MacCallum CA & Russo EB, Delphi consensus, twenty experts/nine countries — maccallum-delphi.txt / memo 03 §2.3.
  3. 3. Sihota A, Smith D, Ahmed S et al. 2021, Int J Clin Practsihota-consensus / memo 03 §2.3.

what_this_protocol_does_NOT_claim

It does not claim strong efficacy — chronic-pain evidence is "small reduction in pain severity, high certainty" (Busse 2018), a rung well below transformative relief; 15–19% of patients do not respond (Allan 2018, OBS). It claims no product-level (chemovar/strain) superiority — no such RCTs exist. It does not claim opioid-sparing efficacy (see EP-07; very low certainty). It does not use terpenes, strain names, or indica/sativa labels.

EP-02 Grade B

Neuropathic pain

CP-NEU-01

Chronic neuropathic pain (peripheral or central)

cannabinoid_ratio

1:1 THC:CBD or THC-containing, titrated; CBD alone is not established here. Rationale: the RCT-validated cannabinoid comparator with a labeled dose unit is nabiximols 1:1 (2.7 mg THC + 2.5 mg CBD per spray, for MS spasticity — the closest labeled anchor); Allan 2018 lists neuropathic/spasticity-adjacent pain in the "some evidence" tier. Grade B (guideline consensus; no dispensary-product RCT).

titration_steps

Busse schedule — if response unsatisfactory on nabiximols-class 1:1 (max 12 sprays/day equivalent), add THC 1–2.5 mg/day, titrate +1–2.5 mg every 2–7 days, max 40 mg/day. For dispensary oral analog: THC:CBD 1:1 oil starting at 1–2.5 mg THC / 2.5–5 mg CBD once daily in the evening. Reassessments per 5×-half-life window (EP-01). Strict stop rule adapted from the Sativex SmPC precedent: if no clinically meaningful improvement after ~4 weeks at tolerated dose, discontinue and refer back (the labeled 20%-improvement-or-stop rule is specific to MS spasticity — its use here is DERIVED, flagged).

route + onset_profile

oromucosal/sublingual preferred where a measured-dose transmucosal product exists (intermediate onset); oral oil otherwise. Sublingual bioavailability figures circulating in the wider literature (~12–35%) are UNVERIFIED — absent from corpus.

contraindications

as EP-01.

interaction_flags

as EP-01.

evidence_grade

B

citations

  1. 1. Busse J et al. 2018, BMJbusse-bmj.txt / memo 03 §2.2.
  2. 2. Sativex SmPC (EMA/HMA), ratio + stop rule — memo 03 §1.3 (verified text on disk via spec corpus).
  3. 3. Allan GM et al. 2018, Can Fam Physician 64(2):111–120 — allan2018-cfp.txt / memo 03 §1.1.

what_this_protocol_does_NOT_claim

No claim that any dispensary chemovar equals nabiximols (§1.3: the labeled product IS the ratio; no evidence a dispensary product outperforms the defined molecule ratio). No claim of disease modification. THC titration ceilings are consensus, not dose-finding RCT output (§2.4).

EP-03 Grade BGrade C

Arthritis / inflammatory joint pain (localized, functional emphasis)

CP-ARTH-01

Chronic arthritic pain with localized dominant joints

cannabinoid_ratio

CBD-dominant oral baseline (same ladder as EP-01), plus optional topical for localized joints (patient-preference adjunct, not dose-equivalent — see EP-13). Grade B/C split: oral ladder B (consensus); topical C (mechanistic/limited — see below).

titration_steps

as EP-01 oral ladder. Topical: no evidence-graded systemic dosing exists — present to patients as a local option with no claimed systemic dose (memo 03 §3.4).

route + onset_profile

oral oil (titration backbone); topical for local complaints with the explicit caveat that Busse 2018 states topicals "may lack pharmacokinetic data establishing their ability to cross the aqueous layer and remain localised" — local delivery is not PK-verified.

contraindications

IBD-adjacent caution does not apply here, but any patient with active inflammatory disease requiring immunosuppressants triggers the tacrolimus/everolimus flag.

interaction_flags

as EP-01.

evidence_grade

B (oral) / C (topical adjunct)

citations

  1. 1. Busse J et al. 2018, BMJ (topical PK caveat) — memo 03 §3.4.
  2. 2. cbd_permeation2004 skin-permeation study (MECH: penetration demonstrated; no systemic-dosing claim supportable) — memo 03 §3.4 Appendix A.
  3. 3. MacCallum & Russo Delphi — maccallum-delphi.txt.

what_this_protocol_does_NOT_claim

No claim that topical CBD/THC reaches therapeutic systemic levels; no claim of structural joint benefit or disease modification; no terpene/stratified claims.

EP-04 Grade BGrade C

Chronic pain with comorbid sleep disturbance — co-benefit only, never a standalone claim

CP-SLEEP-01

Chronic pain where night-time pain disturbs sleep (sleep addressed as a co-benefit of pain management, NOT as a treated indication)

cannabinoid_ratio

same ladder as EP-01; evening-dominant THC scheduling (CAMH titration starts THC in the evening). Grade B for the pain claim; Grade C for sleep — CFPC 2021 Recommendation 4 states cannabis is "not an appropriate therapy" for insomnia pending further research; the sleep benefit observed in pain RCTs (Busse 2018, small-to-very-small, moderate certainty) is a co-benefit, not a standalone indication. This entry explicitly does not sell sleep improvement.

titration_steps

EP-01 ladder, with THC portion dosed in the evening (CAMH). Sulak's optimal-dose framing (titrate down when effects fade) is [ANECD] — may be mentioned as a practice-style de-escalation habit, never as evidence-grade dosing.

route + onset_profile

oral oil evening dose; warn the daytime-impairment risk is back-loaded — oral peak 2–4 h with a long half-life tail (dronabinol t½ 25–36 h; 11-OH-THC 44–59 h).

contraindications

any patient whose primary complaint is insomnia without pain is out of scope — routed to the Grade-D exclusion list, not to a protocol.

interaction_flags

as EP-01; additive CNS-depressant sedation risk is amplified by evening dosing with alcohol/benzodiazepines (labels corrected 2026-09-12: Marinol = "potential for additive central nervous system depression"; Cesamet = "Additive drowsiness and CNS depression"; Cesamet: "This combination should be avoided").

evidence_grade

B (pain) / C (sleep co-benefit)

citations

  1. 1. Busse J et al. 2018, BMJ (sleep co-benefit, moderate certainty) — memo 03 §1.1.
  2. 2. CFPC 2021 (Moulin et al.), Guidance in Authorizing Cannabis Products Within Primary Care, Recommendation 4 — cfpc-guidance2021.txt / memo 03 §1.5.
  3. 3. CAMH, Cannabis and the Cannabinoids medical guide, Appendix 5 — camh-appendix.txt / memo 03 §2.1–2.2.

what_this_protocol_does_NOT_claim

Does not present cannabis as a sleep treatment. Does not use "indica = sedating" (Jikomes 2022: label does not track chemistry). Does not claim the sleep benefit is durable beyond the pain context the RCTs measured.

EP-05 Grade B

Chronic pain in older adults / polypharmacy patients

CP-GERI-01

Chronic pain in patients ≥65 or on ≥5 concurrent medications — the highest-value interaction-screening panel

cannabinoid_ratio

CBD-dominant, most conservative ladder (MacCallum & Russo conservative protocol). Grade B (expert consensus; CAMH explicitly flags this cohort as lowest-tolerance).

titration_steps

CAMH lower bounds govern: may tolerate only 2.5 mg CBD or 1 mg THC at initiation. CBD: 5 mg once daily; titrate +10 mg every 2–3 days to goal or 40 mg/day; then THC per EP-01 with 7-day (not 2-day) titration intervals, max 40 mg/day. Extended reassessment given half-life accumulation and polypharmacy: full steady-state review at ~14 days (DERIVED — flagged).

route + onset_profile

oral oil only at initiation; avoid inhaled (uncontrolled delivered dose: 0.5 g of 10%-THC flower ≈ 7.5–25 mg delivered — a wide band incompatible with this cohort's dose control).

contraindications

as EP-01; fall-risk and cognitive-impairment framing explicitly part of counseling (guideline-tier caution; euphoria is not required for symptom relief — CAMH).

interaction_flags

full consolidated screen mandatory before any dosing — this cohort is the reason the product exists. Clobazam, warfarin, tacrolimus/everolimus, buprenorphine, CNS depressants (benzodiazepines, barbiturates, opioids, alcohol, TCAs, antihistamines, lithium), strong CYP3A4/CYP2C19 inducers (rifampin class).

evidence_grade

B

citations

  1. 1. CAMH Appendix 5 (low-tolerance cohort numbers) — memo 03 §2.2.
  2. 2. MacCallum & Russo Delphi (conservative protocol) — maccallum-delphi.txt.
  3. 3. Marinol/Cesamet labels (additive CNS depression) — marinol-label.txt, cesamet-label.txt / memo 03 §4.3.

what_this_protocol_does_NOT_claim

No claim of safety established for this cohort — these are caution-gated consensus conventions, not geriatric RCTs. No assertion that the screen catches everything — it catches the concentrated, documented set (memo 03 §4 verdict).

EP-06 Grade B

Cancer-associated pain (refractory, third-line)

CP-CANC-01

Chronic cancer pain uncontrolled on standard analgesia

cannabinoid_ratio

1:1 THC:CBD anchoring on the labeled nabiximols ratio (2.7 mg THC + 2.5 mg CBD per spray); dispensary analog = measured 1:1 ratio oil titrated. Grade B/C.

titration_steps

Busse schedule: 1–2.5 mg THC/day, titrate 1–2.5 mg every 2–7 days to max 40 mg/day, after an initial 1:1-class trial. Reassessments per 5×-half-life window (EP-01).

route + onset_profile

oromucosal preferred where a measured 1:1 transmucosal product is stocked; oral oil otherwise. Inhaled only for breakthrough (EP-08).

contraindications

patients on narrow-therapeutic-index chemotherapy or immunosuppressants trigger immediate review — the interaction surface is the dominant risk. CINV management belongs to prescription synthetics (Marinol 5 mg/m² per label) outside this protocol's scope.

interaction_flags

as EP-05 (full screen); tacrolimus/everolimus especially material here (+358%/+200%/+77% plasma increases with CBD — Anton 2022, two case reports + one 6-person trial).

evidence_grade

B

citations

  1. 1. Busse J et al. 2018, BMJ (cancer pain scope + titration) — busse-bmj.txt.
  2. 2. Anton J et al. 2022, J Clin Med (tacrolimus Level 2 numbers) — anton2022_clinrelevance.txt / memo 03 §4.2.
  3. 3. Marinol label (dronabinol CINV dosing, adjacent context) — marinol-label.txt / memo 03 §1.2.

what_this_protocol_does_NOT_claim

No anti-cancer or tumor-modifying claim of any kind. No claim dispensary 1:1 equals nabiximols. No interference-with-treatment assurance beyond the documented interaction screen — anything outside that set is UNVERIFIED, not safe.

EP-07 Grade BGrade CGrade D

Chronic pain in a patient tapering opioids — opioid-sparing posture (very low certainty, consent-gated)

CP-OPIOID-01

Chronic pain where cannabinoid trial runs alongside a prescriber-led opioid taper

cannabinoid_ratio

CBD-dominant ladder as EP-01. Grade B for the titration mechanics (Sihota 2021 consensus exists specifically for titrating cannabinoids while tapering opioids); Grade C/very low certainty for any opioid-sparing effect.

titration_steps

EP-01 ladder; titration and tapering coordinated by the prescriber — the consultant guides the cannabinoid side only. Sihota 2021 is the named consensus reference Busse uses for the 1–2.5 mg THC increments.

route + onset_profile

oral oil.

contraindications

forced opioid tapering is ineffective and may cause harm (Busse 2018, quoting the guideline's own caution) — no taper is initiated or accelerated by this protocol.

interaction_flags

opioids appear in the CNS-depressant additive-sedation flag (pharmacodynamic overlap) — distinguish this from the therapeutic sparing strategy, which is a separate, weakly-evidenced claim.

evidence_grade

B (mechanics) / honest sub-grade C–D for the sparing effect itself (very low certainty evidence)

citations

  1. 1. Busse 2018 citing Noori et al., SR/MA: "The opioid sparing effects of medical cannabis for chronic pain remain uncertain due to very low certainty evidence" — memo 03 §1.9.
  2. 2. Sihota A et al. 2021, Int J Clin Pract (titrating cannabinoids + tapering opioids protocol) — memo 03 §2.3.
  3. 3. Anton J et al. 2022, J Clin Med (buprenorphine Level 2: dose-adjust and monitor) — memo 03 §4.2.

what_this_protocol_does_NOT_claim

Explicitly does not claim cannabis reduces opioid dose. The sparing effect's certainty is "very low" and stated to the patient as such. Any marketing-level "reduce your opioids" framing would exceed the evidence and is barred in consult language.

EP-08 Grade C

Breakthrough (episodic severe) pain — inhaled adjunct

CP-BRKTH-01

Episodic severe breakthrough pain in a patient on a stable oral regimen

cannabinoid_ratio

patient-specific (inherits the stable regimen's ratio); inhaled is the rescue route, not a separate ratio decision. Grade C (PK/observational rationale; no inhaled dosing validation exists).

titration_steps

No validated inhaled dosing exists and this is stated plainly (CAMH: "limited evidence on dosage and interval; there are no validated dosing recommendations"). Reference math only, disclosed as approximate: 0.5 g of 10%-THC flower ≈ 7.5–25 mg THC delivered (CAMH). Counsel lowest-quantity trial, wait, reassess.

route + onset_profile

inhaled — onset within minutes, higher blood levels, shorter duration (Health Canada clinical review, hc-html.txt). Bioavailability CONTESTED: smoked THC 2–56% (Sexton & Ziskind 2013) vs inhaled 15–50% (CAMH) — both reported, not averaged (memo 03 §3.1).

contraindications

smoking-vulnerable respiratory patients steered to vaporized or held at oral-only; inhaled variability makes it a poor primary titration vehicle (memo 03 §3.1).

interaction_flags

as EP-01; additive sedation with the baseline regimen itself.

evidence_grade

C

citations

  1. 1. Health Canada clinical review (hc-html.txt) — inhaled PK — memo 03 §3.1.
  2. 2. CAMH Appendix 5 — delivered-dose math and absence of validated dosing — memo 03 §2.4, §3.1.
  3. 3. Sexton M & Ziskind J 2013 (smoked THC 2–56%) — memo 03 §3.1.

what_this_protocol_does_NOT_claim

No precise inhaled milligram dosing is claimed — none exists in the corpus. The 7.5–25 mg band is disclosed as the reason rescue dosing stays approximate.

EP-09 Grade CGrade B

Chronic pain with comorbid mood distress (anxiety-adjacent) — contested posture

CP-MOOD-01

Chronic pain with secondary anxious distress; anxiety is not being treated, only accounted for in THC-dose risk

cannabinoid_ratio

CBD-dominant; THC introduced only per EP-01 and at the lowest tolerated dose (THC is anxiolytic at low dose, anxiogenic at high dose — MECH, dose-dependent). The secondary literature's claim that CBD "may reduce anxiety associated with THC" applied in Washington-state packaging rules only above CBD:THC ratio 1:5 — [MECH/regulatory interpretation, not clinical proof]. Grade C.

titration_steps

EP-01 conservative ladder; the high-dose-THC ceiling (40 mg/day) is rarely the goal in this cohort. Reassessments per 5×-half-life window.

route + onset_profile

oral oil.

contraindications

patients whose primary complaint is an anxiety disorder are out of scope — CFPC 2021 Rec 4: cannabis "is not an appropriate therapy" for anxiety pending further research; no RCT of dispensary products for anxiety exists in the corpus. Such presentations are routed to the Grade-D exclusion list.

interaction_flags

as EP-01; SSRIs/most antidepressants: no corpus evidence of clinically significant PK interaction — counseled on additive sedation only via the CNS-depressant class; no specific SSRI-PK numbers may be cited.

evidence_grade

C (contested/mechanistic for the anxiety-related elements; B-grade pain ladder underneath)

citations

  1. 1. Anton J et al. 2022, J Clin Med (absence of clinically significant PK evidence for most classes) — memo 03 §4.3–4.4.
  2. 2. CFPC 2021, Recommendation 4 — cfpc-guidance2021.txt / memo 03 §1.6.
  3. 3. Sexton M & Ziskind J 2013 (low-dose anxiolytic / high-dose anxiogenic; CBD-THC ratio claim) — memo 03 §1.6.

what_this_protocol_does_NOT_claim

Does not treat anxiety. Does not invoke CBD-anxiolysis as a benefit claim — evidence is mechanistic and dose/ratio-conditional, with no dispensary-product RCT. States the CONTESTED status where relevant.

EP-10 Grade B

Post-surgical / post-injury chronic pain — standard ladder, timing caveat

CP-POST-01

Chronic pain persisting beyond expected healing after surgery or injury

cannabinoid_ratio

CBD-dominant ladder as EP-01. Grade B (pain-family consensus; no surgery-specific cannabinoid RCTs in corpus).

titration_steps

EP-01 ladder; delay initiation until perioperative analgesic regimens are resolved — additive CNS depression with post-operative opioids is a pharmacodynamic, label-grade risk, not a theorized one.

route + onset_profile

oral oil.

contraindications

active post-operative opioid co-medication → hold cannabinoid initiation pending prescriber coordination (Marinol/Cesamet label additive-depression language).

interaction_flags

as EP-01; opioids (sedation) material here; warfarin flag if on perioperative anticoagulation (INR monitoring around any cannabis start/stop/dose change — Anton 2022 Level 1, probable, CYP2C9).

evidence_grade

B

citations

  1. 1. Busse J et al. 2018, BMJ — memo 03 §1.1, §2.2.
  2. 2. Marinol/Cesamet labels (additive CNS depression) — memo 03 §4.3.
  3. 3. Anton J et al. 2022, J Clin Med (warfarin Level 1) — anton2022_clinrelevance.txt / memo 03 §4.2.

what_this_protocol_does_NOT_claim

No healing-acceleration, tissue-repair, or anti-inflammatory disease-modifying claim. The perioperative timing rule is derived from label-grade pharmacodynamic principles, not from a surgical-population cannabinoid trial.

EP-11 Grade C

Fibromyalgia-widespread-pain presentations — honest thin-evidence entry

CP-FIBRO-01

Widespread chronic pain (fibromyalgia-pattern) in a palliative frame

cannabinoid_ratio

CBD-dominant ladder as EP-01. Grade C — the corpus has no fibromyalgia-specific RCT; the entry rests on the general chronic-pain guideline tier plus observational non-response data (Allan 2018). This entry exists to give a disciplined posture, not to affirm efficacy.

titration_steps

EP-01 conservative ladder; expect and disclose the 15–19% non-response rate; stop rules at 4 weeks absent meaningful improvement (adapted; DERIVED — flagged).

route + onset_profile

oral oil.

contraindications

as EP-01.

interaction_flags

as EP-01.

evidence_grade

C

citations

  1. 1. Busse J et al. 2018, BMJbusse-bmj.txt.
  2. 2. Allan GM et al. 2018, Can Fam Physician (15–19% non-response) — allan2018-cfp.txt.
  3. 3. MacCallum & Russo Delphi — maccallum-delphi.txt.

what_this_protocol_does_NOT_claim

No fibromyalgia-specific efficacy claim; no central-sensitization mechanistic claim as fact (plausibility is Russo 2011-tier [MECH], not proof). Presented to patients as a cautious, titrated, stop-ruled trial, not an expected win.

EP-12 Grade C

Chronic pain in hepatic-impaired patients — dose-reduction gate

CP-HEP-01

Chronic pain in patients with hepatic impairment or elevated baseline transaminases

cannabinoid_ratio

CBD-dominant, at reduced doses with prescriber oversight — the only corpus-verified hepatic-impairment dose-adjustment precedent is the Epidiolex label (pharmaceutical CBD). The dispensary-dose analog is DERIVED, not on label — flagged for the reviewer. Grade C (label-derived, off-label context).

titration_steps

Baseline transaminases + bilirubin required (Epidiolex label §) before any CBD-dominant initiation; initiate at the conservative ladder's floor (5 mg CBD OD; 1–2.5 mg THC max as added) with weekly review. Any transaminase signal stops the trial pending review.

route + onset_profile

oral oil (route cannot avoid first-pass metabolism; the impairment axis is metabolic, not route-dependent).

contraindications

moderate–severe hepatic impairment without prescriber co-management is out of scope; the consultant defers, does not adjudicate.

interaction_flags

as EP-01, plus the hepatic-interaction cluster: valproate 30% ALT >3×ULN when co-administered with clobazam + high-dose CBD; 21% valproate alone; 4% clobazam alone; 3% neither (Epidiolex label, at 10–20 mg/kg/day — exposures far above dispensary dosing; stated for mechanism, not as a dispensary-dose risk number). Clobazam N-desmethylclobazam Cmax/AUC ≈ 3-fold; 7-OH-CBD Cmax +73% / AUC +47% (Epidiolex label, verified verbatim).

evidence_grade

C

citations

  1. 1. Epidiolex FDA label (hepatic impairment, ALT >3×ULN incidence, clobazam interaction) — epidiolex-label.txt / memo 03 §4.2 (verified verbatim).
  2. 2. Busse J et al. 2018, BMJ — memo 03 §1.1.
  3. 3. Anton J et al. 2022, J Clin Med (the interaction-risk-concentration verdict) — memo 03 §4 preamble.

what_this_protocol_does_NOT_claim

The Epidiolex-label hepatic numbers are at 10–20 mg/kg/day pharmaceutical CBD — they are not asserted as dispensary-dose risks. Memo 03 §4.4 is explicit: dispensary CBD exposure is uncontrolled, so risk "cannot be quantified outside pharmaceutical CBD." This entry is a caution gate, not a dosing schedule with established safety.

EP-13 Grade C

Localized pain, topical-first preference — the honest topical entry

CP-TOP-01

Localized musculoskeletal pain where the patient prefers non-systemic products

cannabinoid_ratio

no ratio claim — no evidence-graded systemic dosing for topicals exists in the corpus (memo 03 §3.4). Patient-preference adjunct or primary preference only. Grade C/D boundary; recorded as C with the honesty field carrying the negative.

titration_steps

none evidence-graded. Any topical is applied local-use-per-label with no implied systemic dose; escalation moves to the oral ladder (EP-01) if systemic treatment becomes the goal.

route + onset_profile

topical/transdermal — Busse 2018: topicals "may lack pharmacokinetic data establishing their ability to cross the aqueous layer and remain localised"; cbd_permeation2004 demonstrates skin permeation in vitro (MECH) only.

contraindications

broken skin (standard caution; not corpus-sourced — flagged for reviewer); do not combine with occlusive dressings (practice caution — flagged).

interaction_flags

none evidence-based; systemic transdermal products (not plain topicals) could reach systemic levels and would fold into the full screen.

evidence_grade

C

citations

  1. 1. Busse J et al. 2018, BMJ — topical PK caveat — memo 03 §3.4.
  2. 2. Skin-permeation study cbd_permeation2004 (MECH) — memo 03 §3.4 Appendix A.

what_this_protocol_does_NOT_claim

No systemic effect, no dose-equivalence to oral/inhaled, no "transdermal = sustained systemic dosing" claim (no PK support in corpus). A topical recommendation is presented as local-preference use with no measured systemic exposure.

SL-01 Grade C

Sleep disturbance comorbid with a treated condition (pain-adjacent) — co-benefit, never standalone

SLP-CO-01

Sleep disturbance secondary to a condition with graded evidence (typically chronic pain), where night-time symptoms fragment sleep

cannabinoid_ratio

no separate ratio decision — inherits the underlying condition's ladder (e.g. EP-01 CBD-dominant oral ladder), with any THC portion dosed in the evening per CAMH titration convention (camh-appendix.txt). Grade C (observational/guideline; the sleep improvement seen in pain RCTs is real but small — Busse 2018 BMJ: "small-to-very-small improvement in sleep quality" [moderate certainty] — and is a co-benefit of the pain claim, never a sleep claim).

titration_steps

the underlying condition's ladder unchanged. Evening scheduling only. Reassessments per the 5×-half-life window (dronabinol t½ 25–36 h; 11-OH-THC 44–59 h; CBD 56–61 h — Marinol label / Busse 2018): no increment judged inside 5 days. Adjunct observational anchor (corrected 2026-09-12 — two adjacent studies in the source were previously conflated): (a) Skrabek 2008 — 40 fibromyalgia patients on nabilone 1 mg BID for 4 weeks; pain, Fibromyalgia Impact Questionnaire and anxiety scores benefited vs placebo (p < 0.02); (b) Ware 2010 — 31 patients, nabilone 0.5–1 mg at bedtime, compared with amitriptyline 10–20 mg (NOT placebo); nabilone was superior on an Insomnia Severity Index, with no stated p-value in the quoted review and no benefit on pain, mood or quality of life. Both cited within russo-ced.txt. Observational context only — nabilone is a prescription synthetic, not a dispensary product, and both trial populations are fibromyalgia, not primary insomnia.

route + onset_profile

oral oil, evening dose. Onset 30–60 min, peak 2–4 h, bioavailability 6–20% (CAMH). Warn explicitly that daytime-impairment risk is back-loaded (peak 2–4 h plus long half-life tail — next-morning sedation is a pharmacokinetic expectation, not an idiosyncrasy).

contraindications

a patient whose primary complaint is insomnia is out of scope — routed to the Grade-D exclusion table, not to this protocol. Pregnancy/breastfeeding; uncontrolled psychiatric illness / psychosis history (guideline-tier standard; flagged for reviewer per chronic-pain library open question 5). Sulak's titrate-down-when-effects-fade framing is [ANECD] (projectcbd-sulak.txt) — permissible as a practice-style de-escalation habit, never as dosing evidence.

interaction_flags

full consolidated screen by reference; CNS-depressant row is amplified by evening dosing — alcohol and benzodiazepines at night compound the additive-sedation label warning (labels corrected 2026-09-12: Marinol — "potential for additive central nervous system depression" [§7.1 Additive CNS Effects: dizziness, confusion, sedation, somnolence]; Cesamet — "Additive drowsiness and CNS depression"; and Cesamet: "This combination should be avoided"; marinol-label.txt, cesamet-label.txt).

evidence_grade

C

citations

  1. 1. Busse J et al. 2018, BMJ 363:k4069 (sleep as small co-benefit, moderate certainty) — busse-bmj.txt / memo 03 §1.1, §1.5.
  2. 2. Moulin et al., CFPC 2021, Guidance in Authorizing Cannabis Products Within Primary Care, Recommendation 4 (insomnia: "not an appropriate therapy") — cfpc-guidance2021.txt / memo 03 §1.5.
  3. 3. CAMH, Cannabis and the Cannabinoids, Appendix 5 (evening THC initiation convention) — camh-appendix.txt / memo 03 §2.2.
  4. 4. Ware MA et al. 2010, Anesth Analg 110:604–610 (nabilone fibromyalgia sleep RCT, cited within russo-ced.txt — the underlying trial text is not staged; grade as secondary citation).

what_this_protocol_does_NOT_claim

Does not present cannabis as a sleep treatment. Does not claim durable sleep benefit beyond the pain context the RCTs measured. Does not use "indica = sedating" or any terpene/sedation claim (see standing constraint 1: André 2024's linalool-sleep signal is exploratory in-vitro/review-tier, not clinical). The Ware nabilone datum is not extrapolated to dispensary products.

SL-02 Grade C

Patient already self-medicating with cannabis for sleep — harm-reduction / deprescribing-support posture

SLP-HR-01

Medical-card holder already using cannabis nightly for sleep without clinical supervision — the most common real-world presentation this pharmacy will see

cannabinoid_ratio

no initiation posture (the evidence does not support starting cannabis for sleep). The entry's function is screening + risk-reduction + referral: transition the patient toward the lowest-THC, least-frequency pattern they will accept, with explicit counseling that THC's sleep effects do not self-correct upward — CAMH states dose escalation does not restore effect ("euphoria is not required for effective symptom management"; restart titration on product change) and the corpus flags THC as dose-dependent in effect direction (anxiolytic low / anxiogenic high — Sexton & Ziskind 2013). Grade C.

titration_steps

  1. 01 document current product, route, timing, dose if quantifiable;
  2. 02 convert any inhaled bedtime use to a measured oral evening dose so quantity is numerable (oral onset 30–60 min — time it 60–90 min before intended sleep);
  3. 03 hold any increment to the ≥5-day stability window;
  4. 04 Sulak's 6-day "sensitization protocol" (2 days abstinence + 4 days careful re-titration — cannmed-sulak.txt, projectcbd-sulak.txt) is [ANECD] and may be offered as a practice-style reset explicitly labeled anecdotal;
  5. 05 refer to the certifying practitioner for any upward drift the patient cannot self-limit.

route + onset_profile

oral oil preferred for dose control; inhaled carries the corpus's wide delivered-dose band (0.5 g of 10%-THC flower ≈ 7.5–25 mg THC — CAMH) which is incompatible with accountable dosing.

contraindications

any pattern suggesting a primary sleep disorder (sleep apnea signs, shift-work disorder) or untreated psychiatric condition → referral, not protocol management.

interaction_flags

CNS depressants (alcohol/benzodiazepine bedtime co-use is the highest-frequency real-world hazard in this cohort); the rest of the consolidated screen by reference.

evidence_grade

C

citations

  1. 1. CAMH Appendix 5 (evening dosing; inhaled delivered-dose band; titration restart on product change) — camh-appendix.txt / memo 03 §2.2, §2.4, §3.1.
  2. 2. Sulak D, Healer / Project CBD interview material (optimal-dose framing; 6-day sensitization protocol) — cannmed-sulak.txt, projectcbd-sulak.txt — graded [ANECD], physician case-series with no controlled trial.
  3. 3. CFPC 2021 (Moulin et al.) Recommendation 4 — the reason this entry is harm-reduction rather than initiation — cfpc-guidance2021.txt / memo 03 §1.5.

what_this_protocol_does_NOT_claim

Does not validate the patient's existing regimen as evidence-based care. Does not claim any cannabis product treats a sleep disorder. Does not use Sulak's protocol as evidence-grade dosing — it is an anecdotal de-escalation tool, and the patient is told exactly that.

SL-03 Grade C

Anxiety-adjacent distress (not a diagnosed anxiety disorder) — thinnest entry in the library

ANX-ADJ-01

Sub-syndromal, anxiety-adjacent distress in a cardholder where the certifying practitioner has already authorized a cannabinoid trial; a diagnosed anxiety disorder as the treated condition is Grade D and routes to the exclusion table

cannabinoid_ratio

CBD-dominant only, lowest dose, stop-rule-heavy — THC is not introduced in this entry at all (the dose-dependent anxiogenic risk removes it from matching logic for an anxiety-adjacent presentation: THC is anxiolytic at low doses, anxiogenic at high doses — Sexton & Ziskind 2013, sexton-ziskind-2013-psychoactive-agents.txt [MECH/CONTESTED]). Even the CBD layer is fragile: the only directionally positive corpus material is the secondary-literature claim that CBD "may reduce anxiety associated with THC," which Washington-state packaging guidance permitted only above CBD:THC ratios of 1:5 — a regulatory interpretation, not clinical proof (memo 03 §1.6). Grade C — the thinnest evidence of any entry in either library; stated plainly to patients.

titration_steps

CBD oral oil at the CAMH conservative floor — 2.5–5 mg once daily in the evening, titrate +2.5–5 mg every 3 days to minimal effective dose, ceiling 40 mg/day (CAMH Appendix 5, camh-appendix.txt; Level III expert-consensus conventions, not dose-finding RCTs). Hard stop rules (DERIVED — flagged for reviewer): any increase in anxiety, agitation, or panic → stop and refer; no benefit at 4 weeks on the tolerated ceiling → stop and refer back to the treating clinician (4-week window adapted from the labeled nabiximols review window; DERIVED).

route + onset_profile

oral oil only (oral onset 30–60 min, peak 2–4 h, bioavailability 6–20% — CAMH; camh-appendix.txt). Inhaled excluded — the 7.5–25 mg delivered-dose band for 0.5 g of 10%-THC flower (CAMH) makes anxiolytic-vs-anxiogenic dose control impossible.

contraindications

diagnosed anxiety disorder as the treated condition → Grade D, not this entry. Any prior paradoxical anxiety response to cannabis or THC → decline and refer. Patients seeking primarily euphoric/anxiolytic THC effects → out of scope.

interaction_flags

SSRIs/most antidepressants: no corpus evidence of clinically significant PK interaction (Anton 2022, anton2022_clinrelevance.txt) — counsel on additive sedation only, via the CNS-depressant row; do not cite SSRI-PK numbers. Benzodiazepines: CNS-depressant row material (many anxiety-adjacent patients carry one; additive-sedation label language applies). Full consolidated screen by reference.

evidence_grade

C (contested/mechanistic throughout)

citations

  1. 1. CFPC 2021 (Moulin et al.), Recommendation 4 — cfpc-guidance2021.txt / memo 03 §1.6.
  2. 2. Sexton M & Ziskind J 2013 (THC dose-dependent anxiolysis/anxiogenesis; CBD "may reduce anxiety associated with THC" — Washington-state packaging permitted this claim only above CBD:THC 1:5; regulatory interpretation, not clinical proof) — sexton-ziskind-2013-psychoactive-agents.txt / memo 03 §1.6.
  3. 3. CAMH Appendix 5 (CBD conservative titration numbers) — camh-appendix.txt / memo 03 §2.2.
  4. 4. Anton J et al. 2022, J Clin Med (absence of clinically significant PK evidence for most psychiatric medication classes) — anton2022_clinrelevance.txt / memo 03 §4.3–4.4.

what_this_protocol_does_NOT_claim

Does not treat anxiety. Does not claim CBD anxiolysis as an established benefit — the evidence is mechanistic and dose/ratio-conditional with no dispensary-product RCT in the corpus. Does not recommend any THC-containing product for this presentation. States the CONTESTED status explicitly.

PT-01 Grade D

PTSD — screening/referral posture only (no matched product)

PTSD-SCREEN-01

PTSD presentation in a cardholder; no product-matched protocol exists because the evidence does not support one — this entry is a structured coordinate-and-refer posture, not a treatment

cannabinoid_ratio

none recommended. Grade D for the indication (see exclusion table). The entry exists because "the pharmacist went silent" is not a professional outcome; the legitimate function is screening, interaction-checking any existing self-medication, and referral.

titration_steps

  1. 01 none. Where the treating clinician is already managing a cannabinoid trial (some PA PTSD cardholders arrive this way), the consultant's legitimate role is narrowed to:
  2. 02 full consolidated interaction screen;
  3. 03 dose-measurability counseling (oral over inhaled for accountability);
  4. 04 documenting and reporting back to the treating clinician. No initiation, no titration advice. (DERIVED posture — flagged for reviewer approval.)

route + onset_profile

n/a.

contraindications

initiating or titrating any cannabinoid for PTSD is out of scope — CFPC 2021 Rec 4: cannabis "is not an appropriate therapy" for PTSD pending further research (cfpc-guidance2021.txt); no PTSD RCT is in the corpus (memo 03 §1.7). Russo 2011 (russo-2011-taming-thc.txt) discusses endocannabinoid-system involvement in PTSD — mechanistic plausibility only, not an indication.

interaction_flags

full consolidated screen; CNS-depressant row (this cohort's co-medication rates with benzodiazepines/opioids/alcohol are the real, actionable risk); SSRIs: no corpus PK evidence — additive-sedation counseling only.

evidence_grade

D for the indication (screen/referral posture entry: administrative, recommended as the honest handling of an unsupported request)

citations

  1. 1. CFPC 2021 (Moulin et al.), Recommendation 4 — cfpc-guidance2021.txt / memo 03 §1.7.
  2. 2. Russo EB 2011, Br J Pharmacol 163(7):1344–1364 (endocannabinoid-system discussion; MECH plausibility) — russo-2011-taming-thc.txt / memo 03 §1.7.

what_this_protocol_does_NOT_claim

Makes no treatment claim of any kind. Does not assert cannabis helps or harms PTSD — the corpus is silent beyond the guideline's negative position. The wider-literature nabilone-PTSD trials are deliberately not cited — unstaged and UNVERIFIED (memo 03 §1.7).

NV-01 Grade BGrade D

Nausea/CINV — the synthetic-vs-dispensary distinction; interaction screen only

NAU-CINV-01

Chemotherapy-induced nausea/vomiting question from a cardholder; the library does not recommend dispensary products for CINV — this entry manages the referral + interaction-screen function

cannabinoid_ratio

none recommended from the dispensary side. The RCT-backed, labeled CINV evidence belongs to prescription synthetics: dronabinol (Marinol) — labeled for CINV "in patients who have failed to respond adequately to conventional antiemetic treatments," dosed 5 mg/m² 1–3 hours before chemotherapy, then every 2–4 hours after, 4–6 doses/day (marinol-label.txt, verified verbatim); nabilone (Cesamet), daily range 0.2–6 mg/day (Busse 2018). Allan 2018 lists nausea/vomiting among the areas "with the best evidence" — but that evidence is molecule-level for the synthetics, not product-level for dispensary flower. The gap is the claim: no modern herbal-cannabis CINV RCT is in the corpus (memo 03 §1.2). Grade B for the synthetic-label facts; Grade D for any dispensary-CINV product claim.

titration_steps

  1. 01 none dispensary-side. The consultant's legitimate functions:
  2. 02 point the patient to the oncology prescriber for the labeled synthetics;
  3. 03 run the full consolidated interaction screen against chemo/adjunctive regimens if oncology initiates a synthetic cannabinoid;
  4. 04 document.

route + onset_profile

labeled dronabinol is oral (first dose on an empty stomach ≥30 min before meals — Marinol label). Dispensary-route counseling for CINV is not offered.

contraindications

any marketing-level "dispensary product for chemo nausea" positioning — that claim is Grade D and barred by the exclusion table.

interaction_flags

full consolidated screen material here — oncology regimens commonly hit the flagged classes (CNS depressants incl. opioids; narrow-therapeutic-index agents); the screen is the actual deliverable of this entry.

evidence_grade

B (synthetic-label facts) / D (dispensary-CINV recommendation — excluded)

citations

  1. 1. Marinol (dronabinol) FDA label — indication, 5 mg/m² dosing, administration cautions — marinol-label.txt / memo 03 §1.2 (verified verbatim).
  2. 2. Allan GM et al. 2018, Can Fam Physician 64(2):111–120 (nausea/vomiting in the "best evidence" tier) — allan2018-cfp.txt / memo 03 §1.2.
  3. 3. Busse J et al. 2018, BMJ (nabilone 0.2–6 mg/day range) — busse-bmj.txt / memo 03 §1.2.

what_this_protocol_does_NOT_claim

Does not claim any dispensary chemovar, ratio, or product treats CINV. Does not present the synthetic-label evidence as dispensary-product evidence (memo 03 §1.2: "the labeled product IS the ratio; no evidence a dispensary product outperforms the defined molecule ratio"). Does not advise on oncology prescribing; it refers.