Health Trials

Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy

ConditionsOpioid Use DisorderMethadoneCannabisFentanyl
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorBC Centre on Substance Use

About this trial

This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.

Eligibility criteria

Qualifiers

Individuals of at least 25 years of age or older;

Diagnosed with OUD as per DSM-5 criteria;

Initiated or re-initiated methadone-based OAT within the past 30 days prior to study entry;

Cannabis-use experienced, defined as having used any amount of cannabis in the six months prior to the screening visit;

Disqualifiers

Any disabling, severe, or unstable medical or psychiatric condition that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent, as assessed by medical and psychiatric history, physical examination, vital signs, and/or laboratory tests;

Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute alcohol intoxication) that, in the opinion of the study physician, precludes safe participation in the study;

Currently pregnant or breastfeeding, or planning to become pregnant;

Known or suspected allergy or hypersensitivity to cannabinoids;

Trial design

Treatments tested in this trial

  • Aurora 1:1 Drops (Indica)
  • Placebo

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

BC Centre on Substance Use

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov