RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08-07
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06691243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years old
  2. 2. Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
  3. 3. Used cocaine at least 7 out of the past 14 days
  4. 4. Body Mass Index between 20 - 50 kg/m2
  5. 5. English proficiency
  6. 6. In people of childbearing potential, agree to use an acceptable method of birth control
  1. 1. Triglycerides \> 500 mg/dL
  2. 2. History of gall bladder disease
  3. 3. Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  4. 4. History of diabetic retinopathy
  5. 5. Being prescribed glucose-lowering medications
  6. 6. An estimated glomerular filtration rate of less than 45 ml/min
  7. 7. Lifetime history of taking semaglutide or other GLP-1 RAs
  8. 8. Current suicidal ideation or suicide attempts within the past 24 months
  9. 9. Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5
  10. 10. Use of weight-lowering medications
  11. 11. History of gastric bypass surgery
  12. 12. History of myocardial infarction or stroke within the past 12 months
  13. 13. Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
  14. 14. Any contraindicated medical issues identified by the study investigators
  15. 15. 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.
  16. 16. Calcitonin value equal to or above 50 ng/L
  17. 17. If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan
  18. 18. If completing the MRI portion of the study: presence of a metal device in the body (e.g. pacemaker. Infusion pump, aneurysm clip, metal prosthesis or plate

Contacts and Locations

Study Contact

Onyinyechi Ogbumbadiugha-Weekes
CONTACT
443-635-4943
oogbumbadiugha@ihv.umaryland.edu
Sarah Kattakuzhy
CONTACT
443-691-4638
skattakuzhy@ihv.umaryland.edu

Study Locations (Sites)

Institute of Human Virology at the University of Maryland School of Medicine
Washington, District of Columbia, 20002
United States
Institute of Human Virology at the University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-07
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • semaglutide
  • GLP-1
  • cocaine use disorder

Additional Relevant MeSH Terms

  • Cocaine Use Disorder
  • HIV