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New treatment option for Opioid Use Disorder
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)?
Aurora 1:1 Drops (Indica) is an investigational medicine, being studied as a potential treatment 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
- 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.
- 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;
- 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...
- 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. for Phase 2 In addition to meeting all eligibility criteria outlined in Phase 1, participants will be eligible for...
- 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. In cases where impairment persists beyond the initial 10-hour period, participants must continue...
- 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's taking place
- 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 - 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?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.