Opioid Use DisorderPhase 2THC-MMTNCT05985850
Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy
A Phase 2 study testing Aurora 1:1 Drops (Indica) in people with Opioid Use Disorder and Methadone, run by BC Centre on Substance Use at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Opioid Use Disorder, Methadone, Cannabis
- What is being tested?
- Aurora 1:1 Drops (Indica)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Josie Kanu, BSc, 6045001102, josie.kanu@bccsu.ubc.ca
M. Eugenia Socias, MD, MSc, eugenia.socias@bccsu.ubc.ca
About this study
Official title: Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)
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.
Read the 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
- Being tested
- Aurora 1:1 Drops (Indica), Placebo
- Keywords
- addiction, Opioid Use Disorder, Cannabis, Harm Reduction, Opioid, Pain, Quality of Life, Cannabidiol
- Medical subject headings
- Opioid-Related Disorders, Marijuana Abuse, Behavior, Addictive, Harm Reduction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Medium-chain triglyceride (MCT) oil with the same appearance, color, and taste as the Aurora 1:1 Drops (Indica).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 24 weeks
Blinding effectiveness
The blinding success questionnaire will be used to evaluate the participants' awareness of their assigned treatment.
Measured: 24 weeks
Adequacy of Dose
Patient satisfaction with dose level assessed through the adequacy of dose questionnaire and regular consultations
Measured: 24 weeks
Secondary outcomes (5)
The number of potential participants referred to the study
Measured: 24 weeks
The screening failure rates
Measured: 24 weeks
The monthly enrolment rates
Measured: 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
Measured: 24 weeks
The proportion of scheduled study visits completed by study arm
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start23 May 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: 1:1 randomization Phase 2: Open-label
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BC Centre on Substance Use
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, M. Eugenia Socias, BC Centre on Substance Use
- Investigators
- M Eugenia Socias, MD, MSc., Principal investigator, Assistant Professor, Department of Medicine, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985850
- Sponsor's protocol ID
- BCCSU-005
- Acronym
- THC-MMT
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)
- ClinicalTrials.gov ID
- NCT05985850
- Acronym / sponsor ID
- THC-MMT / BCCSU-005
- Conditions
- Opioid Use Disorder, Methadone, Cannabis, Fentanyl
- Keywords
- addiction, Opioid Use Disorder, Cannabis, Harm Reduction, Opioid, Pain, Quality of Life, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- BC Centre on Substance UseUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 23 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: 1:1 randomization Phase 2: Open-label
| Arm | Type | Receives |
|---|---|---|
| Aurora 1:1 Drops (Indica) | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: PlaceboFormulated 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Aurora 1:1 Drops (Indica) |
| PlaceboMedium-chain triglyceride (MCT) oil with the same appearance, color, and taste as the Aurora 1:1 Drops (Indica). | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 weeks
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.
Risk of Treatment Contamination
Time frame: 24 weeks
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).
Participants' adherence to treatment
Time frame: 24 weeks
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.
Acceptability
Time frame: 24 weeks
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.
Blinding effectiveness
Time frame: 24 weeks
The blinding success questionnaire will be used to evaluate the participants' awareness of their assigned treatment.
Adequacy of Dose
Time frame: 24 weeks
Patient satisfaction with dose level assessed through the adequacy of dose questionnaire and regular consultations
5 secondary outcomes
The number of potential participants referred to the study
Time frame: 24 weeks
The screening failure rates
Time frame: 24 weeks
The monthly enrolment rates
Time frame: 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
Time frame: 24 weeks
The proportion of scheduled study visits completed by study arm
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
M Eugenia Socias, MD, MSc. principal investigator
Assistant Professor, Department of Medicine, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aurora 1:1 Drops (Indica) in people with Opioid Use Disorder and Methadone, run by BC Centre on Substance Use at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josie Kanu, BSc (6045001102, josie.kanu@bccsu.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 28 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.