Semaglutide for Cocaine Use Disorder

(STAC Trial)

Recruiting at 1 trial location

Overseen By Sarah Kattakuzhy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Must not be taking: Glucose-lowering, Weight-lowering, GLP-1 RAs, others

Disqualifiers: Diabetes, Gall bladder disease, others

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

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether semaglutide, a medication typically used for diabetes and weight management, is safe and well-tolerated for individuals with cocaine use disorder, regardless of HIV status. Participants will receive either semaglutide or a placebo (a harmless substance resembling the drug) through weekly injections. The trial seeks individuals who have used cocaine frequently in the past two weeks and meet other specific criteria. Participants will visit the clinic weekly for injections and every two weeks for check-ups and assessments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on glucose-lowering or weight-lowering medications.

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

Research has shown that semaglutide is generally safe for use. The FDA has already approved it for treating type 2 diabetes and aiding weight loss, indicating a well-understood safety profile. In studies on cocaine addiction, semaglutide has shown potential in reducing cravings and use. For example, a 54-year-old patient reported a significant decrease in cocaine cravings over 12 weeks while taking semaglutide.

Although specific information on side effects for cocaine addiction is limited, its existing approval for other uses and early research suggest that semaglutide could be safe for this new purpose. However, like any medication, it may have side effects, so monitoring them carefully during the trial is important. ^{1 2 3 4 5}

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

Most treatments for cocaine use disorder focus on behavioral therapies and medications like disulfiram or naltrexone, which target the brain's reward system. But semaglutide works differently, originally developed as a treatment for diabetes and obesity, it targets the GLP-1 receptors. This unique mechanism could help reduce cocaine cravings by influencing pathways related to addiction. Researchers are excited about semaglutide because it could offer a new approach by acting on the brain's chemistry in a way that current treatments don't, potentially leading to more effective management of cocaine use disorder. Plus, its once-weekly injection is a convenient option compared to daily medications, making it easier for patients to stick to their treatment plans.

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

Research has shown that semaglutide, which participants in this trial may receive, may help reduce cocaine use. In animal studies, semaglutide lowered cocaine intake and reduced the chances of relapse. A human case study found a significant drop in cocaine cravings, with one person's craving score decreasing from 5.6 to 2.3 over 12 weeks. Researchers believe semaglutide can make cocaine less rewarding, reducing its temptation. These findings suggest semaglutide could be useful in treating cocaine use disorder. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with cocaine use disorder, who have used cocaine frequently in the past two weeks and have a BMI between 20-50. They must speak English and agree to birth control if they can have children. People with HIV are also included.

Inclusion Criteria

I have used cocaine on 7 or more days in the last two weeks.

I am proficient in English.

I agree to use birth control if I can have children.

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 injections once a week, with labwork, assessments, and surveys every two weeks

16 weeks

16 visits (in-person for injections), 8 visits (in-person for labwork and assessments)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional MRI

Participants who consent to optional MRI visits will complete MRI scans at two timepoints

16 weeks

2 visits (in-person for MRI)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The trial is testing Semaglutide's safety and effectiveness for those with cocaine use disorder, comparing it against a placebo. Participants will receive weekly injections of either Semaglutide or placebo, along with regular lab work and assessments.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Once weekly injection of semaglutide

Group II: Placebo Placebo Group 1 Intervention

Once weekly injection of placebo

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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. 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 ...

3. 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 ...

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/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 ...

6. 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 ...