Cannabis Use Disorder, ModeratePhase 3NCT07671248
Tirzepatide in the Treatment of Cannabis Use Disorder
A Phase 3 study testing Tirzepatide in people with Cannabis Use Disorder, Moderate and Cannabis Use Disorder, Severe, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B8
Beth Patterson, 905-921-7644, bpatter@mcmaster.ca
About this study
Official title: A 12-Week Phase 3 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Tirzepatide-Assisted-Psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study
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.
- Being tested
- Tirzepatide
- Keywords
- Cannabis Use Disorder, Motivational Enhancement Therapy, Tirzepatide
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 12-week endpoint.
Secondary outcomes (4)
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.
Measured: From baseline to 12-week endpoint.
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.
Measured: 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.
Measured: 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.
Measured: From baseline to 12-week endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use Disorder, ModerateStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Van Ameringen, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671248
- Sponsor's protocol ID
- Tirzep_CUD
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Phase 3 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Tirzepatide-Assisted-Psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT07671248
- Acronym / sponsor ID
- Tirzep_CUD
- Keywords
- Cannabis Use Disorder, Motivational Enhancement Therapy, Tirzepatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: TirzepatideThis is an open-label single arm intervention. All participants will be offered both Tirzepatide and psychotherapy over the 12-week treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideTreatment 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). | Drug | Single Arm |
Primary outcome
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Time frame: 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.
Time frame: 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.
4 secondary outcomes
Frequency and amount of cannabis use
Time frame: From baseline to 12-week endpoint.
Severity of Cannabis Use Disorder symptoms
Time frame: From baseline to 12-week endpoint
Cannabis cravings
Time frame: From baseline to 12-week endpoint
Cannabis withdrawal symptoms
Time frame: From baseline to 12-week endpoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Cannabis Use Disorder, Moderate and Cannabis Use Disorder, Severe, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Patterson (905-921-7644, bpatter@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder. (time frame: From baseline to 12-week endpoint.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.