The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, randomized, placebo-controlled, crossover design trial will be used to test the effect of exenatide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this research is to determine whether exenatide has effects on alcohol consumption.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Exenatide

Criteria

Inclusion Criteria:

1. 21-55 years of age

2. Able to verify age with a state or federal picture identification

3. Exceeds safe weekly drinking limits (14 drinks for women or 21 drinks for men per week)

4. Reports at least one episode of binge drinking (>3 for women, >4 for men) an average of once per week in the four weeks prior to baseline screening.

5. Meets Diagnostic Statistical Manual 5 criteria for mild alcohol use disorder or greater severity.

Exclusion Criteria:

1. Seeking treatment for alcohol problems.

2. Clinical Institute Withdrawal Assessment at ≥10

3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine, marijuana or caffeine.

4. If female, pregnant, nursing, have plans to become pregnant.

5. If female, does not agree to use an accepted form of birth control.

6. Has a medical contraindication to the use of exenatide.

7. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated.

8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS).

9. Body Mass Index is less than 18 or greater than or equal to 30.

10. History of diabetes.

11. Baseline hemoglobin A1c ≥ 6.5%

12. Baseline nonfasting glucose >200

13. Significantly elevated serum lipase levels.

14. Impaired renal function (GFR <80 mL/min).

15. Pancreatitis, gastroparesis or other severe gastrointestinal disease.

16. Has had gastric bypass surgery

17. Subject is currently taking warfarin.

18. Has received alcohol counseling or other non-pharmacologic intervention to treat Alcohol use disorder in the past 90 days.

19. Has taken medications that are used to treat Alcohol Use Disorder in the past 90 days.

20. Subjects with a history of thyroid cancer or other thyroid disease.

21. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines.

22. Prior history of anaphylaxis or angioedema with another GLP-1 receptor agonist.

23. Prior use of exenatide

24. Liver function values AST or ALT are twice the normal limit

25. Unable to comfortably abstain from nicotine for a period of 8 hours.