Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
Conditions
Keywords
Cannabis Use Disorder, Motivational Enhancement Therapy, Tirzepatide
Brief summary
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.
Interventions
DRUGTirzepatide
Treatment 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).
Sponsors
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * A Body Mass Index (BMI) ≥ 22
Exclusion criteria
* 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 * Meet DSM-5 criteria for alcohol or substance use disorder for any substance other than cannabis or tobacco in the past 6 months * Positive urine drug screen for any substance except cannabis * Concurrent addiction-focused psychotherapy in the past 6 months * Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months * A personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 * Current unstable medical condition * A lifetime diagnosis of Diabetes * Females who are pregnant/nursing, or individuals in reproductive age who do not consent to using birth control during the study * Concomitant treatment with: other GLP-1 agonists, Contrave, bupropion, naltrexone, acamprosate within the past year. No lifetime treatment with tirzepatide. * Significant literacy, visual, or hearing problems * Co-enrollment in a clinical drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder. | From baseline to 12-week endpoint. | 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. |
| Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder. | From baseline to 12-week endpoint. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and amount of cannabis use | From baseline to 12-week endpoint. | 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. |
| Severity of Cannabis Use Disorder symptoms | From baseline to 12-week endpoint | 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. |
| Cannabis cravings | From baseline to 12-week endpoint | The Marijuana Craving Questionnaire - Short Form (MCQ-SF) is a self-report 12-item questionnaire used to assess individual's cannabis craving experiences. |
| Cannabis withdrawal symptoms | From baseline to 12-week endpoint | 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. |
Countries
Canada
Contacts
CONTACTBeth Patterson
Outcome results
None listed