Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy (NCT05985850) | Clinical Trial Compass
RecruitingPhase 2
Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy
Canada24 participantsStarted 2024-05-23
Plain-language summary
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.
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Willing to only use study-provided cannabis as directed by study protocol, including abstention from non-study cannabis and cannabinoids;
✓. Agree to keep all study medication stored in a secure location and not to share/distribute study medication to any other individual;
✓. If assigned female sex at birth:
✓. Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and over 45 years of age); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
Exclusion criteria
✕. 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;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. Currently pregnant or breastfeeding, or planning to become pregnant;
✕. Known or suspected allergy or hypersensitivity to cannabinoids;
✕. History of respiratory disease, severe cardiovascular, cerebrovascular, renal or liver disease;
✕. Current or historic cannabis use disorder;
✕. Taking warfarin, clopidogrel, clobazam, theophylline, clozapine and olanzapine medications as they may interact with cannabinoids in a clinically significant manner if they cannot be switched to a different medication;
✕. Any personal or family history (first degree relative) of primary psychotic disorders (i.e., schizophrenia, schizoaffective disorder) as per DSM-5 criteria;