Opioid Use Disorder study: Aurora
Official title Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy
ClinicalTrials.gov ID: NCT05985850
What this study is testing
What is Aurora 1:1 Drops (Indica)?
An investigational cannabis oil being studied as an adjunct therapy for opioid use disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if adding THC/CBD oil to methadone treatment is safe and practical for people with opioid use disorder.
- Who it's for
- Adults who are receiving methadone for opioid use disorder and are willing to try cannabis oil.
- What's involved
- Participants will receive a 1:1 THC/CBD cannabis oil while continuing their methadone therapy, and will be monitored for safety and feasibility.
- Time commitment
- The study lasts a short pilot period with regular check‑ins to track safety and usage.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join 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;
You likely can't join if
- Any disabling, severe, or unstable medical or psychiatric condition that, in the opinion of the study physician, precludes safe participation in the...
- Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute alcohol intoxication) that, in the opinion of 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;
See the full eligibility 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;
- Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and over 45 years of age)
- If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;
- 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.
- 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...
- 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.
- Actively participating in other treatment clinical trial(s);
- Incarcerated, pending legal action or other reasons that might prevent completion of the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.