Trials / Completed
CompletedNCT04360044
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.
Detailed description
In this double-blind, randomized, crossover trial, subjects will treat 4 separate migraine attacks with 4 different treatments. Inhaled cannabis will be administered using a portable vaporization system (Mighty Medic; Storz \& Bickel) based on a validated Storz \& Bickel system and using a standardized inhalation approach. Subjects will self-administer inhaled cannabis as early as possible in the course of a migraine (see Procedure), taking 4 puffs of 1) THC, 2) THC/CBD mix, 3) CBD, or 4) placebo. Patients will treat each of the 4 distinct migraine attacks with a different cannabis sample. Outcomes measured will include pain freedom and pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 1 hour, 2 hours (primary outcome), 24 hours, and 48 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | THC ~5% | 4 puffs of vaporized flower containing THC \~5% |
| DRUG | CBD ~12% | 4 puffs of vaporized flower containing CBD \~12% |
| DRUG | THC ~5% and CBD ~12% | 4 puffs of vaporized flower containing THC \~5% and CBD \~12% |
| DRUG | Sham Cannabis | 4 puffs of vaporized flower from which the THC and CBD have been extracted |
Timeline
- Start date
- 2020-11-20
- Primary completion
- 2023-02-23
- Completion
- 2023-02-23
- First posted
- 2020-04-24
- Last updated
- 2023-02-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04360044. Inclusion in this directory is not an endorsement.