Semaglutide + Cognitive Behavioral Therapy for Cocaine Use Disorder

Overseen By Jessica Vincent

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Insulin, Weight management drugs

Disqualifiers: Diabetes, Severe cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semaglutide, a medication often used for weight management, works effectively with cognitive behavioral therapy (CBT) to treat cocaine use disorder. Researchers aim to determine if this combination can reduce cocaine cravings and use. Suitable participants have been diagnosed with cocaine use disorder and have a body mass index (BMI) of 25 or higher, indicating they are overweight. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

You may need to stop taking certain medications to join the trial. Specifically, you cannot be using medications like sincalide, sulfonylureas, insulin, or any medication used for weight management. If you're on other medications, the study doctor will decide if they could affect your safety or the study.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide, the treatment under study, holds promise based on earlier findings. For instance, a 54-year-old patient using semaglutide experienced a significant reduction in cocaine cravings over 12 weeks, suggesting potential benefits for cocaine use disorder.

While semaglutide is being tested for this new application, it already has FDA approval for conditions like type 2 diabetes and weight management, indicating its safety for those uses. However, its safety specifically for treating cocaine use disorder remains under investigation.

As this study is in an early phase, it likely focuses on the tolerability of semaglutide for this new purpose. In studies for other uses, semaglutide has generally been well-tolerated. Here, the emphasis will be on its effects on individuals with cocaine use disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cocaine use disorder?

Semaglutide is unique because it targets the glucagon-like peptide-1 (GLP-1) receptor, a different mechanism compared to most current treatments for cocaine use disorder, which often rely on behavioral therapies and medications aimed at reducing cravings or withdrawal symptoms. Researchers are excited about semaglutide because it was originally developed for diabetes and obesity, suggesting it might influence reward pathways in the brain in innovative ways. This could potentially offer a new approach to treating cocaine addiction, addressing both physical and psychological aspects of the disorder.

What evidence suggests that semaglutide might be an effective treatment for cocaine use disorder?

Research has shown that semaglutide, a drug commonly used for diabetes, might help with cocaine addiction. In animal studies, it lowered cocaine use and the urge to take cocaine. Another study with a human patient showed a significant decrease in cocaine cravings over 12 weeks. In this trial, participants will receive either semaglutide or a placebo to evaluate its effectiveness. Semaglutide changes brain pathways, making cocaine less appealing. This suggests it could effectively help people with cocaine addiction. ^{1 2 5 6 7}

Who Is on the Research Team?

Luba Yammine, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of ≥25 kg/m2 who meet the criteria for Cocaine Use Disorder, have used cocaine recently (confirmed by urine test), and can provide informed consent. Participants must not have significant medical or psychiatric conditions that could interfere with the study, be willing to use contraception if female and of childbearing potential, and plan to stay in the area during the trial.

Inclusion Criteria

Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study

Have body mass index (BMI) of ≥25 kg/m2

Have a medical and psychiatric history and a brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the Study Physician and the Principal Investigator

Exclusion Criteria

Current or recent suicidal ideation

Known or suspected hypersensitivity to semaglutide, excipients, or related products

Current ≥ moderate substance use disorder aside from alcohol, nicotine, or marijuana, or a Substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo in combination with cognitive behavioral therapy for cocaine use disorder

15 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study tests whether semaglutide combined with cognitive behavioral therapy (CBT) helps treat Cocaine Use Disorder. Semaglutide is a medication originally used for diabetes; here it's repurposed to see if it reduces cocaine use. Some participants will receive semaglutide while others get a placebo, both alongside CBT.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0924977X25001300

Semaglutide suppresses cocaine taking, seeking, and ... Semaglutide decreased cocaine self-administration, the motivation to consume cocaine, and cocaine reinstatement in male rats. Moreover, semaglutide attenuated ...

2. uth.edu uth.edu/news/story/researchers-to-study-the-effects-of-semaglutide-on-cocaine-use-disorder

Researchers to study the effects of semaglutide on cocaine ... “We think that semaglutide can help decrease the rewarding effects of stimulants such as cocaine,” Yammine said. “Let's say you experience ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11834608/

Use of semaglutide in a 54-year-old patient with cocaine ... A notable outcome was the significant reduction in cocaine cravings. The patient's CCQ-Brief score decreased from 5.6 to 2.3 over 12 weeks, a ...

4. gu.se gu.se/en/news/semaglutide-reduces-cocaine-use-in-rats

Semaglutide reduces cocaine use in rats In animal studies, researchers at the University of Gothenburg, Sweden, found that semaglutide reduced both cocaine use and relapse.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07227948

Repurposing Semaglutide for the Treatment of Cocaine ... Consistent with this, animal studies have shown that GLP-1RAs reduce the rewarding and reinforcing effects of various addictive substances, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06691243?term=SEMAGLUTIDE&viewType=Table&page=5&rank=49

NCT06691243 | Evaluation Of Semaglutide in Adults With ... 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 ...

7. pharmacytimes.com pharmacytimes.com/view/semaglutide-could-offer-potential-treatment-for-cocaine-use-disorder

Semaglutide Could Offer Potential Treatment for Cocaine ... Semaglutide significantly reduced cocaine-seeking behavior and motivation in rats, indicating potential for treating cocaine dependency. The ...