NCT04360044

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

April 21, 2020

Last Update Submit

February 24, 2023

Conditions

MigraineCannabisTHCCBD

Keywords

MigraineCannabisTHCCBD

Outcome Measures

Primary Outcomes (1)

  • Headache Pain Relief at 2 Hours Post-Treatment

    Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain

    2 Hours Post-Treatment

Secondary Outcomes (2)

  • Headache pain freedom

    2 hours

  • Most bothersome symptom freedom

    2 hours

Other Outcomes (10)

  • Headache pain relief

    1 hour, 24 hours, 48 hours

  • Headache pain freedom

    1 hour, 24 hours, 48 hours

  • Most bothersome symptom freedom

    1 hour, 24 hours, 48 hours

  • +7 more other outcomes

Study Arms (4)

THC ~5%

EXPERIMENTAL

4 puffs of cannabis flower containing THC \~5% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Drug: THC ~5%

THC ~5%/CBD ~12%

EXPERIMENTAL

4 puffs of cannabis flower containing THC \~5% and CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Drug: THC ~5% and CBD ~12%

CBD ~12%

EXPERIMENTAL

4 puffs of cannabis flower containing CBD \~12% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Drug: CBD ~12%

Sham Cannabis

SHAM COMPARATOR

4 puffs of cannabis flower from which the THC and CBD have been extracted administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Drug: Sham Cannabis

Interventions

THC ~5%DRUG

4 puffs of vaporized flower containing THC \~5%

Also known as: THC, delta 9-tetrahydrocannabinol, marijuana
THC ~5%
CBD ~12%DRUG

4 puffs of vaporized flower containing CBD \~12%

Also known as: CBD, cannabidiol, hemp
CBD ~12%
THC ~5% and CBD ~12%DRUG

4 puffs of vaporized flower containing THC \~5% and CBD \~12%

Also known as: THC, CBD, delta 9-tetrahydrocannabinol, cannabidiol, marijuana, hemp
THC ~5%/CBD ~12%
Sham CannabisDRUG

4 puffs of vaporized flower from which the THC and CBD have been extracted

Also known as: Placebo, Sham
Sham Cannabis

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 and ≤ 65
  • Able to communicate in English
  • Migraine, with or without aura, in its episodic or chronic manifestations, as per the International Headache Society (IHS) classification International Classification of Headache Disorders (ICHD-3) criteria (section 1.1, 1.2, 1.3).(48)
  • Ability to provide informed consent and complete website questionnaires in English
  • Agrees not to use cannabis outside of the study during participation in the study
  • Agrees not to use opioids or barbiturates during participation in the study
  • Agrees not to drive a motor vehicle within 4 hours following last use of inhaled cannabis during participation in the study

You may not qualify if:

  • Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to enrollment
  • Pregnancy
  • Breastfeeding
  • Prisoner
  • Known cognitive impairment
  • Institutionalized
  • Current moderate-severe or severe depression
  • Current or past history of bipolar depression, schizophrenia, or psychosis
  • Current or past history of cannabis, alcohol, opioid, or amphetamine abuse or other substance use disorder at the discretion of the research team
  • Active pulmonary disease class IV heart failure, cirrhosis, or other severe medical illnesses at the discretion of the research team.
  • Allergy or past adverse effects or negative past experiences from cannabis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Pain Medicine, UC San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Migraine DisordersMarijuana Abuse

Interventions

THC 5DronabinolnabiximolsCannabidiolsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Nathaniel M Schuster, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 4 treatments will be identically encapsulated by the study pharmacist using Storz \& Bickel filling set. The study pharmacist will place the capsules in identical sealed plastic bags labeled "Migraine 1" through "Migraine 4."
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

November 20, 2020

Primary Completion

February 23, 2023

Study Completion

February 23, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 year and ending 5 years after article publication
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu.

Locations

US(1)