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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05427630
Other study ID # 802999
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date February 15, 2023
Est. completion date June 1, 2024

Study information

Verified date April 2024
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot crossover study will evaluate 3 different potencies of inhaled cannabis (2.5%, 5%, and 10%) and inhaled placebo cannabis for the acute treatment of migraine.


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 system. Subjects will self-administer inhaled cannabis as early as possible in the course of a migraine, taking 4 puffs of 1) THC 2.5%, 2) THC 5%, 3) THC 10%, or 4) placebo. Patients will treat each of the 4 distinct migraine attacks with a different cannabis sample. Outcomes measured will include pain freedom, most bothersome symptom (MBS), and pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, and 48 hours.


Recruitment information / eligibility

Status Suspended
Enrollment 20
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - 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 4.5 hours following last use of inhaled cannabis during participation in the study Exclusion Criteria: - 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 to cannabis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
THC ~2.5%
Cannabis flower containing THC ~2.5%
THC ~5%
Cannabis flower containing THC ~5%
THC ~10%
Cannabis flower containing THC ~5%
Sham Cannabis
Cannabis flower from which the THC and CBD have been extracted

Locations

Country Name City State
United States Center for Pain Medicine, UC San Diego La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Headache pain freedom Dichotomous outcome of reduction from moderate/severe to no pain 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other Most bothersome symptom (MBS) Dichotomous outcome of resolution of MBS (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other Headache pain relief Dichotomous outcome of reduction from moderate/severe to mild/no pain 15 minutes, 30 minutes, 1 hour, 1.5 hours, 4 hours, 24 hours, 48 hours
Other Freedom from photophobia Dichotomous outcome of resolution of photophobia 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other Freedom from phonophobia Dichotomous outcome of resolution of phonophobia 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other Freedom from nausea Dichotomous outcome of resolution of nausea 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 24 hours, 48 hours
Other Freedom from vomiting Dichotomous outcome of whether patient vomited during this migraine attack At any time over 48 hours
Other Use of rescue medication Dichotomous outcome of use of rescue medication At any time over 48 hours
Other Sustained pain freedom Dichotomous outcome of absence of headache pain at 2 hours after dose, with no use of rescue medication and no recurrence of headache pain 24 hours and 48 hours
Other Sustained most bothersome symptom freedom (MBS) Dichotomous outcome of absence of MBS at 2 hours after dose, with no use of rescue medication and no recurrence of MBS 24 hours and 48 hours
Primary Headache Pain Freedom at 2 Hour Post-Treatment Dichotomous outcome of pain freedom defined as reduction from moderate/severe pain to no pain 2 Hours Post-Treatment
Secondary Most Bothersome Symptom (MBS) Freedom at 2 Hours Post-Treatment Dichotomous outcome of resolution of most bothersome symptom (of photophobia, phonophobia, or nausea) selected at the beginning of the migraine prior to cannabis administration 2 Hours Post-Treatment
Secondary Headache Pain Relief at 2 Hours Post-Treatment Dichotomous outcome of pain reduction defined as reduction from moderate/severe pain to mild/no pain 2 Hours Post-Treatment
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