Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
ConditionCannabis Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugParticipants 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.
Placebo
DrugParticipants will receive weekly masked injections of placebo.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
24 weeks (Treatment Phase)2
Days of Abstinence
Number of days per week with no cannabis use, as assessed by Timeline Follow Back (TLFB).
Time frame
24 weeks (Treatment Phase)Secondary outcomes
1
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
Time frame
24 weeks (Treatment Phase)2
Negative Urine Drug Screens (UDS)
Percentage of weekly urine drug screens testing negative for cannabis out of all scheduled weekly drug screens.
Time frame
24 weeks (Treatment Phase)3
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.
Time frame
24 weeks (Treatment Phase)4
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)
Time frame
24 weeks (Treatment Phase)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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