Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | This is an open-label single arm intervention. All participants will be offered both Tirzepatide and psychotherapy over the 12-week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12-week endpoint. |
| 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. | From baseline to 12-week endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12-week endpoint. |
| Severity of Cannabis Use Disorder symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12-week endpoint |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Patterson | Contact | 905-921-7644 | bpatter@mcmaster.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacAnxiety Research Centre | Hamilton | Ontario | L8S 1B8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| From baseline to 12-week endpoint |
| 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. | From baseline to 12-week endpoint |
| 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. | From baseline to 12-week endpoint |
| 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. | From baseline to 12-week endpoint |
| 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. | From baseline to 12-week endpoint. |
| 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. | From baseline to 12-week endpoint. |
| Change from baseline in OCD symptoms | The Obsessive Compulsive Inventory - Revised (OCI-R) is an 18-item self-report questionnaire that assesses various obsessions. | From baseline to 12-week endpoint. |
| Change in baseline quality of life | The World Health Organization Quality of Life assessment (WHOQOL-BREF) is a self-report measure that assesses quality of life across physical health, psychological, social relationships, and environment domains. The WHOQOL-BREF consists of 26 items that are rated on a 5-point Likert scale. Scores are transformed to range from 0 to 100, with higher scores indicating better quality of life. | From baseline to 12-point endpoint. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |