DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07468552

Not yet recruitingPhase 2

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

—

Enrollment

100

estimated

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoints

•Maximum Tolerated Dose (MTD)•Days of Abstinence

Identifiers

Registered as

NCT IDNCT07468552
Org study IDNIDA/VA CS #1037

Timeline

Milestones

Study first posted2026-03-12actual
Last update posted2026-03-12actual
Study start2026-11-15estimated
Primary completion2028-03-15estimated
Study completion2028-11-15estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
4
Patient-reported / QoL
2
Safety / tolerability / PK
2

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Cannabis Craving

Time frame:24 weeks (Treatment Phase)

change from baseline, improvement

Secondary/protocol endpoint

Quality of Life

Time frame:24 weeks (Treatment Phase)

descriptive, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Maximum Tolerated Dose (MTD)

Time frame:24 weeks (Treatment Phase)

descriptive

Secondary/protocol endpoint

Retention in Treatment

Time frame:Week 24 (End of Treatment Phase)

descriptive

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Days of Abstinence

Time frame:24 weeks (Treatment Phase)

descriptive, improvement

Secondary/protocol endpoint

Severity of Cannabis Use Disorder (CUD)

Time frame:24 weeks (Treatment Phase)

change from baseline, improvement

Secondary/protocol endpoint

Negative Urine Drug Screens (UDS)

Time frame:24 weeks (Treatment Phase)

threshold achievement, improvement

Secondary/protocol endpoint

1. Cannabis Withdrawal

Time frame:24 weeks (Treatment Phase)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.