Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy

NCT ID: NCT05985850

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2027-03-31

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.

Detailed Description

This is a single-site, two-phase pilot clinical trial evaluating the safety and feasibility of administering a balanced 1:1 ratio of THC:CBD cannabis oil alongside methadone-based opioid agonist therapy (OAT) in a community setting.

Phase 1 is a 12-week, double-blind, randomized controlled study involving 24 eligible participants with opioid use disorder (OUD) who recently initiated or re-initiated methadone-based OAT. Participants will be randomly assigned to receive either balanced THC:CBD cannabis oil or placebo oil. All participants will receive OUD clinical care, including OAT management, independent of research visits.

After the 12-week blinded treatment period (Phase 1), eligible participants will be invited to Phase 2, a 12-week open-label treatment extension study with all participants receiving balanced THC:CBD cannabis oil. Follow-up research visits will occur every two weeks from the start of open-label treatment.

Conditions

Opioid Use Disorder; Methadone; Cannabis; Fentanyl

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aurora 1:1 Drops (Indica)

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.

Group Type: EXPERIMENTAL

Aurora 1:1 Drops (Indica)

Intervention Type: 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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Aurora 1:1 Drops (Indica)

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Individuals of at least 25 years of age or older;

2. Diagnosed with OUD as per DSM-5 criteria;

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

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

5. Willing to only use study-provided cannabis as directed by study protocol, including abstention from non-study cannabis and cannabinoids;

6. Agree to keep all study medication stored in a secure location and not to share/distribute study medication to any other individual;

7. If assigned female sex at birth:

1. 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

2. If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;

8. 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:

1. Participants who have not experienced a study medication-related serious adverse event during Phase 1;

2. Participants who have not been lost to follow-up during Phase 1.

Exclusion Criteria

1. 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;

2. 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;

3. Currently pregnant or breastfeeding, or planning to become pregnant;

4. Known or suspected allergy or hypersensitivity to cannabinoids;

5. History of respiratory disease, severe cardiovascular, cerebrovascular, renal or liver disease;

6. Current or historic cannabis use disorder;

7. 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;

8. Any personal or family history (first degree relative) of primary psychotic disorders (i.e., schizophrenia, schizoaffective disorder) as per DSM-5 criteria;

9. 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;

10. Actively participating in other interventional clinical trial(s);

11. Incarcerated, pending legal action or other reasons that might prevent completion of the study.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

BC Centre on Substance Use

OTHER

Sponsor Role: lead

Responsible Party

M. Eugenia Socias

Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M Eugenia Socias, MD, MSc.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Medicine, University of British Columbia

Locations

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

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Josie Kanu, BSc

Role: CONTACT

josie.kanu@bccsu.ubc.ca

6045001102

Facility Contacts

Josie Kanu, BSc

Role: primary

josie.kanu@bccsu.ubc.ca

6045001102

M. Eugenia Socias, MD, MSc

Role: backup

eugenia.socias@bccsu.ubc.ca

Other Identifiers

BCCSU-005

Identifier Type: -

Identifier Source: org_study_id