Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy

NCT05985850 | Recruiting Phase 2

• 1 other identifier: BCCSU-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder; Methadone; Cannabis; Fentanyl

Keywords

addiction; Opioid Use Disorder; Cannabis; Harm Reduction; Opioid; Pain; Quality of Life; Cannabidiol

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The safety will be evaluated by monitoring and gathering information on physical exam, vital signs, pregnancy testing, adverse events (AE) and serious adverse events (SAE), from the screening visit up to the End of Treatment (EOT)/Early Termination visit. AEs and SAEs will be monitored and recorded throughout the study duration. The proportion of participants who experience AEs or SAEs will be assessed by study arm.

  28 weeks

• Risk of Treatment Contamination

  The proportion of participants using non-study cannabis in the control arm, and proportion of days in Phase 1 where non-study cannabis was used. Self-report of non-study cannabis use will be collected using the Timeline Follow Back (TLFB).

  24 weeks

• Participants' adherence to treatment

  The degree of compliance with the recommended treatment plan, including study drug dosage and administration. This measures how well participants are able to stick to the prescribed treatment regimen and whether or not they are able to complete the full course of treatment. This will be assessed through a self-reported measure, such as study drug diary or treatment logs.

  24 weeks

• Acceptability

  Participant satisfaction with the assigned treatment will be assessed through administration of the Medical Safety Questionnaire (MSQ) every 4 weeks during treatment phase The MSQ is a participant-completed questionnaire that evaluates participant satisfaction with study treatment on a 7-point Likert scale.

  24 weeks

• Blinding effectiveness

  The blinding success questionnaire will be used to evaluate the participants' awareness of their assigned treatment.

  24 weeks

• Adequacy of Dose

  Patient satisfaction with dose level assessed through the adequacy of dose questionnaire and regular consultations

  24 weeks

Secondary Outcomes (5)

• The number of potential participants referred to the study

  24 weeks

• The screening failure rates

  24 weeks

• The monthly enrolment rates

  24 weeks

• The proportion of eligible participants who are willing to be randomized, willing to initiate the intervention and willing to complete 12-week assessments by study arm

  24 weeks

• The proportion of scheduled study visits completed by study arm

  24 weeks

Other Outcomes (9)

• Retention in OAT

  24 weeks

• Illicit opioid use

  24 weeks

• Pain Intensity

  24 weeks

Study Arms (2)

Aurora 1:1 Drops (Indica)

EXPERIMENTAL

Aurora 1:1 Drops (Indica) Balanced 1:1 ratio of THC and CBD packaged in a 30 mL bottle: THC: 16.8 mg/g (+/- 15%) CBD: 16.8 mg/g (+/- 15%) Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.

Drug: Aurora 1:1 Drops (Indica)

Placebo

PLACEBO COMPARATOR

Formulated using the same medium chain triglyceride (MCT) oil as Aurora 1:1 Drops (Indica) Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.

Drug: Placebo

Interventions

Aurora 1:1 Drops (Indica) DRUG

Aurora 1:1 Drops (Indica) is created by extracting cannabinoids and terpenes and the concentrated extract is then diluted in medium-chain triglyceride (MCT) oil for optimal use.

Aurora 1:1 Drops (Indica)

Placebo DRUG

Medium-chain triglyceride (MCT) oil with the same appearance, color, and taste as the Aurora 1:1 Drops (Indica).

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;
• Ability to understand and comply with study protocol procedures and to provide written informed consent.
• In addition to meeting all eligibility criteria outlined in Phase 1, participants will be eligible for Phase 2 provided they meet ALL the following criteria at Week 12:
• Participants who have not experienced a study medication-related serious adverse event during Phase 1;
• Participants who have not been lost to follow-up during Phase 1.

You may not qualify if:

• 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;
• 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;
• Unable to abstain from driving any vehicle or operating machinery for at least 10 hours after taking the study medication. In cases where impairment persists beyond the initial 10-hour period, participants must continue to adhere to these restrictions until the impairment resolves;
• Actively participating in other interventional clinical trial(s);
• Incarcerated, pending legal action or other reasons that might prevent completion of the study.

Sponsors & Collaborators

• BC Centre on Substance Use: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Marijuana Abuse; Behavior, Addictive; Harm Reduction; Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• M Eugenia Socias, MD, MSc.

  Assistant Professor, Department of Medicine, University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josie Kanu, BSc

CONTACT

6045001102; josie.kanu@bccsu.ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Model Details: Phase 1: 1:1 randomization Phase 2: Open-label

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: May 23, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)