Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

NCT06691243 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HP-0011223775N90024C00036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo. Participants will:

• Visit the clinic once a week for semaglutide or placebo injections
• Visit the clinic once every two weeks for labwork, assessments and/or surveys
• If consented to optional MRI's, complete two MRI's

Conditions

Cocaine Use Disorder; HIV

Keywords

semaglutide; GLP-1; cocaine use disorder

Outcome Measures

Primary Outcomes (2)

• Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV

  Number of Grade 3 and 4 adverse effects reported by patients at any time after Day 0

  16 weeks

• Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV

  Dose of semaglutide the patient tolerates regardless of the presence of adverse effects

  16 weeks

Secondary Outcomes (20)

• Determine if semaglutide improves cocaine use frequency in people with CUD with and without HIV

  16 weeks

• Determine if semaglutide reduces cocaine use in people with CUD with and without HIV

  16 weeks

• Determine if semaglutide reduces cocaine use in people with CUD with and without HIV

  16 weeks

• Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV

  16 weeks

• Determine if semaglutide reduces drug use severity for people with CUD with and without HIV

  16 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

Once weekly injection of semaglutide

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Once weekly injection of placebo

Drug: Placebo

Interventions

Semaglutide DRUG

The initial dose will be semaglutide 0.25mg which, if tolerated, will be escalated to 0.5mg. Escalation will continue to 1.0 mg and afterwards to 2.0 mg. The highest possible dose will be 2.0mg semaglutide.

Also known as: Wegovy, Ozempic

Semaglutide

Placebo DRUG

Patients randomized to placebo arm will receive placebo injection every week.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
• Used cocaine at least 7 out of the past 14 days
• Body Mass Index between 20 - 50 kg/m2
• English proficiency
• In people of childbearing potential, agree to use an acceptable method of birth control

You may not qualify if:

• Triglycerides \> 500 mg/dL
• History of gall bladder disease
• Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• History of diabetic retinopathy
• Being prescribed glucose-lowering medications
• An estimated glomerular filtration rate of less than 45 ml/min
• Lifetime history of taking semaglutide or other GLP-1 RAs
• Current suicidal ideation or suicide attempts within the past 24 months
• Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5
• Use of weight-lowering medications
• History of gastric bypass surgery
• History of myocardial infarction or stroke within the past 12 months
• Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
• Any contraindicated medical issues identified by the study investigators
• Risk of conditions that are under Warning and Precautions section of OZEMPIC and WEGOVY including but not limited to known history or current report of clinically relevant hypoglycemia, gastroparesis, or pancreatic disease.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Institute of Human Virology at the University of Maryland School of Medicine

Washington D.C., District of Columbia, 20002, United States

RECRUITING

Institute of Human Virology at the University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Interventions

semaglutide

Central Study Contacts

Onyinyechi Ogbumbadiugha-Weekes

CONTACT

443-635-4943; oogbumbadiugha@ihv.umaryland.edu

Sarah Kattakuzhy

CONTACT

443-691-4638; skattakuzhy@ihv.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 15, 2024
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after study completion.
• Access Criteria: Investigators can email the Principal Investigator (PI) with access requests and the PI will judge if the use of data is justified. If the PI deems the research question appropriate, the PI will grant access.

Locations

US (2)