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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

A double-blind, randomized, placebo-controlled, crossover design trial was 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 was to determine whether exenatide has effects on alcohol consumption.

Key facts

Study ID

NCT03645408

Run by

Boston Medical Center

People needed

8

Starts

2019-05-02

Expected to finish

2021-07-01

Last updated by the study team

2022-02-09

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21-55 years of age.
• Able to verify age with a state or federal picture identification.
• Exceeds safe weekly drinking limits [4 standard drink units (SDUs) for women or 21 SDUs for men per week]
• Reports at least one episode of binge drinking (>3 SDUs for women, >4 SDUs for men) an average of once per week in the four weeks prior to baseline screening.
• Meets Diagnostic And Statistical Manual Of Mental Disorders, Fifth Edition (DSM-5)criteria for mild alcohol use disorder or greater severity.

You may not qualify if…

• Seeking treatment for alcohol problems.
• Clinical Institute Withdrawal Assessment at ≥10
• 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.
• If female, pregnant, nursing, have plans to become pregnant.
• If female, does not agree to use an accepted form of birth control.
• Has a medical contraindication to the use of exenatide.
• Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated.
• Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS).
• BMI is less than 18 or greater than or equal to 30.
• History of diabetes.
• Baseline hemoglobin A1c ≥ 6.5%
• Baseline non fasting glucose >200
• Significantly elevated serum lipase levels.
• Impaired renal function (GFR <80 mL/min).
• Pancreatitis, gastroparesis or other severe gastrointestinal disease.
• Has had gastric bypass surgery
• Subject is currently taking warfarin.
• Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days.
• Has taken medications that are used to treat alcohol use disorder (AUD) in the past 90 days.
• Subjects with a history of thyroid cancer or other thyroid disease.
• Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines.
• Prior history of anaphylaxis or angioedema with another GLP-1 receptor agonist.
• Prior use of exenatide
• Liver function values AST or ALT are twice the normal limit
• Unable to comfortably abstain from nicotine for a period of 8 hours.

Where it is running

• Boston University Psychiatry Research Center, Clinical Studies Unit — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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