The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring exenatide, alcohol craving, alcohol consumption
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Has Chronic obstructive pulmonary disease (COPD), history of solid organ transplant, sickle cell disease, severe heart disease or other health condition for which exposure to COVID-19 represents an unreasonable risk as determined by the study staff physician using accepted COVID-19 guidance (e.g. Centers for Disease Control, etc.).
- Subject has prior history of Drug-induced thrombocytopenia
Sites / Locations
- Boston University Psychiatry Research Center, Clinical Studies Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Exenatide then Placebo
Placebo then Exenatide
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a 5 mcg dose of immediate release exenatide on the day of the first alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Subjects in this arm then received a sham injection on the day of the second alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this arm received a sham injection on the day of the first alcohol self-administration trial. The sham injection was a needle stick using a syringe with no drug injected. Subjects in this arm then received a 5 mcg dose of immediate release exenatide on the day of the second alcohol self-administration trial. The 5mcg dose of exenatide was approved as the first dose administered to patients at the start of their treatment with this drug for FDA-approved indications. Note that the volume of fluid injected for a 5mcg dose is so small that subjects would not sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind.