Tirzepatide in the Treatment of Cannabis Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
Cannabis is the most commonly used psychoactive substance in Canada. A sub-group of cannabis users develop Cannabis Use Disorder (CUD). CUD is a pattern of cannabis use that results in impairment in functioning, symptoms of tolerance, withdrawal, and distress. Several pharmacological and psychosocial interventions have been evaluated for their efficacy in treating CUD, however they lack high success rates. GLP-1RA's have shown promising results in reducing food and alcohol cravings and intake. Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonist. Tirzepatide has been reported to reduce alcohol consumption, and therefore may have promising effects as a treatment for CUD. This study aims to evaluate the feasibility and tolerability of weekly injections of Tirzepatide combined with Motivational Enhancement Therapy in adults with CUD. This trial will be the first to examine the potential therapeutic effects of Tirzepatide in CUD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 and above
DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
4 or more days of cannabis use per week
Treatment seeking
Disqualifiers
Meet DSM-5 criteria for Cluster A or B personality disorders and/or unstable current bipolar disorder, schizophrenia, or psychotic disorder
Comorbid severe DSM-5 Major Depressive Disorder
Present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study, as determined by the study physician and Columbia Suicide Severity Rating Scale
Any other mental health condition deemed incompatible by the study team
Trial design
Design model
Single group
Treatments tested in this trial
Tirzepatide
DrugTreatment will occur over a 12-week period, with once-weekly injections of escalating doses every 3 weeks from 2.5mg to 10mg. Tirzepatide will be used in conjunction with Motivational Enhancement Therapy (MET).
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Tolerability will be measured by the percent of participants who discontinue the trial. Tolerability will also be measured by the percent of participants who reach the target dose.
Time frame
From baseline to 12-week endpoint.2
Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Feasibility will be evaluated based on the number of people who contact the study team, percent of people that contact who are eligible and percent of eligible participants who enroll.
Time frame
From baseline to 12-week endpoint.Secondary outcomes
1
Frequency and amount of cannabis use
The Enhanced Cannabis Timeline Follow Back (EC-TLFB) obtains information about frequency of cannabis use, amount used, types of cannabis products, and methods of administration.
Time frame
From baseline to 12-week endpoint.2
Severity of Cannabis Use Disorder symptoms
The Self-Reported Symptoms of Cannabis Use Disorder (SRSCUD) is a 13-item self-report form that allows individuals to rate the severity of their Cannabis Use Disorder on a scale from 1 to 4. Total scores range from 0 to 39, with a higher score indicating greater symptom severity.
Time frame
From baseline to 12-week endpoint3
Cannabis cravings
The Marijuana Craving Questionnaire - Short Form (MCQ-SF) is a self-report 12-item questionnaire used to assess individual's cannabis craving experiences.
Time frame
From baseline to 12-week endpoint4
Cannabis withdrawal symptoms
The Marijuana Withdrawal Checklist (MWC) is a self-report 15-item questionnaire used to assess symptoms of cannabis withdrawal. Participants rate items on a Likert scale from 0 (not at all) to 3 (severe) based on their most recent period of cannabis abstinence. Scores range from 0 to 45, with higher scores indicating greater withdrawal symptom severity.
Time frame
From baseline to 12-week endpointOther outcomes
1
Change from baseline on the severity of anxiety symptoms
The Generalized Anxiety Disorder-7 (GAD-7) is a self-report 7-item questionnaire that measures anxiety symptom severity. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater symptom severity.
Time frame
From baseline to 12-week endpoint2
Change from baseline on Attention Deficit Hyperactivity Disorder symptom severity
The Barkley's Adult ADHD Rating Scale - I (BAARS-IV) is a 21 item self-report questionnaire that assesses ADHD symptom severity.
Time frame
From baseline to 12-week endpoint3
Change from baseline in depression symptoms
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure with 9-items used to assess the presence of depression symptoms in the past 2 weeks. Items are scored on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depression severity.
Time frame
From baseline to 12-week endpoint.4
Change from baseline in functional impairment
The Sheehan Disability Scale (SDS) is a self-report scale of functional impairment. Responses are based on an eleven-point scale from 0 (not at all) to 10 (extremely). Total scores range from 0 to 30, with higher scores indicating greater impairment.
Time frame
From baseline to 12-week endpoint.Sponsors and contacts
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Source ClinicalTrials.gov
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