Cannabidiol as Adjunctive Treatment for Opioid Use Disorder
Status:
Not yet recruiting
Trial end date:
2023-11-15
Target enrollment:
Participant gender:
Summary
This research aims to determine the effects and safety of cannabidiol (CBD) as an adjunctive
therapy for patients, who have Opioid Use Disorder and are taking buprenorphine + naloxone.
Buprenorphine + naloxone is an approved treatment for Opioid Use Disorder, but relapse to
opioid misuse is common among patients who receive this treatment. Finding an adjunctive
treatment that does not have abuse liability and reduces relapse for these patients would be
helpful.
Investigators will recruit participants from the Tarzana Treatment Center in Los Angeles.
They will be receiving buprenorphine + naloxone as part of residential therapy. Potential
participants who pass initial screening and wish to continue in the study will provide
written, informed consent and will complete a screening evaluation, including blood and urine
tests, questionnaires about their mood, medical, psychiatric and drug use history and a
physical exam.
Sixty participants who meet all eligibility criteria will be invited to complete baseline
assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive
CBD or placebo in each of three cohorts, corresponding to two dose groups of 20 participants
per cohort (CBD 600, 1200mg/day). Within each cohort, 20 participants will receive CBD and 10
will receive placebo. The cohorts will be studied in ascending dose order to ensure safety.
Each day, participants will take the study medication twice daily under supervision.
Questionnaires on opioid craving, withdrawal, and mood symptoms will be administered daily
during the treatment period. Cue-induced craving will be assessed at 3 timepoints (days 0, 7
and 28). PK samples will be assessed at multiple time-points during the study.
After the 28-day intervention, participants will complete questionnaires and undergo urine
drug tests in weekly follow-up visits (days 29-56). PK samples will be assessed at multiple
time-points during the follow-up period.
The study will last ~9 weeks, comprising three periods: a screening period (~7 days during
which participants are stabilized on buprenorphine + naloxone in residential treatment at
Tarzana Treatment Center), a treatment period (4 weeks when study CBD or placebo is
administered at UCLA), and a follow-up period (4 weeks after termination of the test
intervention).