Cannabis Use DisorderPhase 2NCT07468552
Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
A Phase 2 study testing Tirzepatide in people with Cannabis Use Disorder, run by National Institute on Drug Abuse (NIDA).
Trial summary
The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Nov 2028
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age
- Meets DSM-5 criteria for moderate or severe CUD
- Interested in treatment for cannabis use disorder
- Able to understand the study procedures and written informed consent in English
- Willing to comply with all study procedures and medication instructions
- If female, is not pregnant, and agrees to use acceptable birth control methods
Who cannot join
- Body Mass Index (BMI) ≤ 23 kg/m²
- Presence of a medical or psychiatric disorder that contraindicates participation in the study
- Substance use disorder other than tobacco or mild alcohol-use disorder
- Known allergy or hypersensitivity to Tirzepatide, any GLP-1 or GIP receptor agonist, or any of the excipients in the product
- Current or recent (past 30 days) use of GLP-1 receptor agonists or other weight-loss drug
- Current or recent (past 6 months) enrollment in substance use disorder treatment
- Current or planned pregnancy and breastfeeding
- Living or medical situation that would interfere with adherence to the study protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)
The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.
Read the detailed description
This is a double-blind, placebo-controlled, randomized clinical trial. 100 individuals with moderate to severe cannabis use disorder (CUD) will be randomized in a 1:1 ratio to receive either (1) weekly subcutaneous injections of tirzepatide or (2) weekly subcutaneous injections of matching placebo for 24 weeks. Tirzepatide will be initiated at 2.5 mg for 4 weeks (4 injections) and increased in 2.5 mg increments every 4 weeks as tolerated, up to a maximum dose of 15 mg.
The Primary Objective is to determine the maximum tolerated dose (MTD) of tirzepatide in individuals with CUD and to evaluate its efficacy in reducing cannabis use.
The primary Hypothesis is that tirzepatide will be well tolerated within the FDA-recommended dose range and compared with placebo, it will result in a significantly greater proportion of cannabis abstinent days as measured by the timeline follow-back (TLFB).
Secondary Objectives are to evaluate the effects of tirzepatide, relative to placebo, on (1) CUD severity based on DSM-5 criteria; (2) percentage of cannabis-negative weekly urine drug screens collected during the treatment period; (3) cannabis craving; (4) cannabis withdrawal severity; (5) retention in treatment; and (6) quality of life.
- Conditions
- Cannabis Use Disorder
- Being tested
- Tirzepatide, Placebo
- Keywords
- Cannabis Use, Cannabis Addiction, Marijuana Addiction
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Participants will receive weekly injections of tirzepatide 2.5 mg for 4 weeks. The dose is expected to increase by 2.5 mg every 4 weeks, however, the decision to increase the dose will be made based on the Dose Increase Checklist and shared decision between the site study physician (MD or DO) and the participant.
PlaceboDrug
Participants will receive weekly masked injections of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Not described Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The maximum tolerated dose defined as the median dose within the FDA-recommended range, at which dose increase is not recommended (based on standardized and health care provider assessments).
Measured: 24 weeks (Treatment Phase)
Days of Abstinence
Number of days per week with no cannabis use, as assessed by Timeline Follow Back (TLFB).
Measured: 24 weeks (Treatment Phase)
Secondary outcomes (6)
Severity of Cannabis Use Disorder (CUD)
Severity of CUD as determined by DSM-5 criteria for Cannabis Use Disorder Checklist and expressed as a number of reported symptoms
Measured: 24 weeks (Treatment Phase)
Negative Urine Drug Screens (UDS)
Percentage of weekly urine drug screens testing negative for cannabis out of all scheduled weekly drug screens.
Measured: 24 weeks (Treatment Phase)
Cannabis Craving
Cannabis Craving as assessed by the short form of the Marijuana Craving Questionnaire (MCQ) and expressed as a score. The score range is 12-84, and the higher score indicates a higher or more frequent level of craving.
Measured: 24 weeks (Treatment Phase)
1. Cannabis Withdrawal
Cannabis withdrawal as assessed by the DSM 5 Cannabis Withdrawal Checklist and expressed as a number of symptoms present (up to 7)
Measured: 24 weeks (Treatment Phase)
Retention in Treatment
Percentage of randomized participants who receive study medication during the treatment phase.
Measured: Week 24 (End of Treatment Phase)
Quality of Life
Quality of life (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain intensity) as determined by PROMIS-29 questionnaire and expressed as a score. The domain scores (T-scores) range is 20-80 with higher scores representing better outcomes.
Measured: 24 weeks (Treatment Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Nov 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 DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel, randomized trial with 1:1 assignment to treatment versus placebo. The starting dose of active the medication (tirzepatide) is 2.5 mg, and is expected to increase by 2.5 mg every 4 weeks based on its tolerability and participant's adherence
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jia Bei Wang, MD, PhD, Principal investigator, NIDA/NIH, Division of Therapeutics and Medical Consequences (DTMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468552
- Sponsor's protocol ID
- NIDA/VA CS #1037
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)
- ClinicalTrials.gov ID
- NCT07468552
- Acronym / sponsor ID
- NIDA/VA CS #1037
- Conditions
- Cannabis Use Disorder
- Keywords
- Cannabis Use, Cannabis Addiction, Marijuana Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 12 Mar 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.
The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.
Detailed description
This is a double-blind, placebo-controlled, randomized clinical trial. 100 individuals with moderate to severe cannabis use disorder (CUD) will be randomized in a 1:1 ratio to receive either (1) weekly subcutaneous injections of tirzepatide or (2) weekly subcutaneous injections of matching placebo for 24 weeks. Tirzepatide will be initiated at 2.5 mg for 4 weeks (4 injections) and increased in 2.5 mg increments every 4 weeks as tolerated, up to a maximum dose of 15 mg.
The Primary Objective is to determine the maximum tolerated dose (MTD) of tirzepatide in individuals with CUD and to evaluate its efficacy in reducing cannabis use.
The primary Hypothesis is that tirzepatide will be well tolerated within the FDA-recommended dose range and compared with placebo, it will result in a significantly greater proportion of cannabis abstinent days as measured by the timeline follow-back (TLFB).
Secondary Objectives are to evaluate the effects of tirzepatide, relative to placebo, on (1) CUD severity based on DSM-5 criteria; (2) percentage of cannabis-negative weekly urine drug screens collected during the treatment period; (3) cannabis craving; (4) cannabis withdrawal severity; (5) retention in treatment; and (6) quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel, randomized trial with 1:1 assignment to treatment versus placebo. The starting dose of active the medication (tirzepatide) is 2.5 mg, and is expected to increase by 2.5 mg every 4 weeks based on its tolerability and participant's adherence
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Tirzepatide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 70 years of age
- Meets DSM-5 criteria for moderate or severe CUD
- Interested in treatment for cannabis use disorder
- Able to understand the study procedures and written informed consent in English
- Willing to comply with all study procedures and medication instructions
Key exclusion criteria (8 listed)
- Body Mass Index (BMI) ≤ 23 kg/m²
- Presence of a medical or psychiatric disorder that contraindicates participation in the study
- Substance use disorder other than tobacco or mild alcohol-use disorder
- Known allergy or hypersensitivity to Tirzepatide, any GLP-1 or GIP receptor agonist, or any of the excipients in the product
- Current or recent (past 30 days) use of GLP-1 receptor agonists or other weight-loss drug
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 |
|---|---|---|
| TirzepatideParticipants will receive weekly injections of tirzepatide 2.5 mg for 4 weeks. The dose is expected to increase by 2.5 mg every 4 weeks, however, the decision to increase the dose will be made based on the Dose Increase Checklist and shared decision between the site study physician (MD or DO) and the participant. | Drug | Active Treatment |
| PlaceboParticipants will receive weekly masked injections of placebo. | Drug | Placebo |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 24 weeks (Treatment Phase)
The maximum tolerated dose defined as the median dose within the FDA-recommended range, at which dose increase is not recommended (based on standardized and health care provider assessments).
Days of Abstinence
Time frame: 24 weeks (Treatment Phase)
Number of days per week with no cannabis use, as assessed by Timeline Follow Back (TLFB).
6 secondary outcomes
Severity of Cannabis Use Disorder (CUD)
Time frame: 24 weeks (Treatment Phase)
Negative Urine Drug Screens (UDS)
Time frame: 24 weeks (Treatment Phase)
Cannabis Craving
Time frame: 24 weeks (Treatment Phase)
1. Cannabis Withdrawal
Time frame: 24 weeks (Treatment Phase)
Retention in Treatment
Time frame: Week 24 (End of Treatment Phase)
Quality of Life
Time frame: 24 weeks (Treatment Phase)
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 21 Sep 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.
Jia Bei Wang, MD, PhD principal investigator
NIDA/NIH, Division of Therapeutics and Medical Consequences (DTMC)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Cannabis Use Disorder, run by National Institute on Drug Abuse (NIDA).
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 6 inclusion and 8 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jana Drgonova, PhD (301-827-5933, jana.drgonova@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 24 weeks (Treatment Phase)). 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 21 Sep 2026.