Health TrialsbyHealthPanel

Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy

ConditionsOpioid Use DisorderMethadoneCannabisFentanyl
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorBC Centre on Substance Use

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Aurora 1:1 Drops (Indica)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 weeks
2

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).

Time frame
24 weeks
3

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.

Time frame
24 weeks
4

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.

Time frame
24 weeks

Secondary outcomes

1

The number of potential participants referred to the study

Time frame
24 weeks
2

The screening failure rates

Time frame
24 weeks
3

The monthly enrolment rates

Time frame
24 weeks
4

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

Other outcomes

1

Retention in OAT

Retention in OAT will be measured by the proportion of participants on OAT at W12 and at W24, defined as having both a) an active OAT prescription at week 12/24, and b) a positive UDT result for the prescribed OAT at week 12/24.

Time frame
24 weeks
2

Illicit opioid use

Suppression of illicit opioid use will be measured as the percentage of opioid-free weeks during W1-12, using a combination of Urine Drug Test (UDT) results and self-reported illicit opioid use assessed by the TLFB.

Time frame
24 weeks
3

Pain Intensity

The severity of pain will be assessed by the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): the PROMIS Pain Intensity item.

Time frame
24 weeks
4

Pain Interference

The impact of pain on its impact on functioning will be assessed the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): PROMIS SF v1.0 - Pain Interference 4a scale.

Time frame
24 weeks

Sponsors and contacts

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BC Centre on Substance Use

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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