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

ConditionsCocaine Use DisorderHIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Maryland, Baltimore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
16 weeks
2

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

Time frame
16 weeks

Secondary outcomes

1

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

Change from baseline to highest tolerated semaglutide or placebo dose in cocaine use frequency via timeline followback method. The higher the frequency of cocaine use, the worse the outcome.

Time frame
16 weeks
2

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

Change from baseline to highest tolerated semaglutide or placebo dose of mean dollar-amount patients spent on cocaine during the past 7 days. The higher the amount, the worse the outcome.

Time frame
16 weeks
3

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

Change from baseline to highest tolerated semaglutide or placebo dose in presence of cocaine metabolite detected on urine drug-screen results.

Time frame
16 weeks
4

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

Change from baseline to highest tolerated semaglutide or placebo dose in score on Cocaine Craving Questionnaire Brief (CCQ-Brief). Minimum score= 8 (minimal craving). Maximum score= 56 (extreme craving). The higher the score, the worse the outcome.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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