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

NCT03645408 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: H-38015R21AA027332-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

exenatide; alcohol craving; alcohol consumption

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption

  Alcohol consumption was measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. The amount not consumed was then subtracted from the total amount of alcohol served to the subject in order to calculate the amount consumed. This outcome was measured in standard drink units (SDUs). A standard drink contains approximately 0.6 fluid ounces of pure alcohol.

  2 hours

Study Arms (2)

Exenatide then Placebo

EXPERIMENTAL

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.

Drug: Exenatide; Other: Sham injection

Placebo then Exenatide

EXPERIMENTAL

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.

Drug: Exenatide; Other: Sham injection

Interventions

Exenatide DRUG

Subject received an injection of 5 mcg of immediate release exenatide.

Also known as: Byetta

Exenatide then Placebo; Placebo then Exenatide

Sham injection OTHER

Subjects received a sham injection with no study drug.

Also known as: Placebo

Exenatide then Placebo; Placebo then Exenatide

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Psychiatry Research Center, Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Exenatide; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Limitations and Caveats

The small sample size reflects the early termination of the research which was halted due to Covid 19 precautions.

Results Point of Contact

• Title: Dr. Eric Devine
• Organization: Boston Medical Center/Boston University School of Medicine

eric.devine@bmc.org

617-414-1990

Study Officials

• Eric Devine, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Nursing staff at the general Clinical Research unit were not blinded to the study medication. These nurses' only role in the study was providing injections of the study drug. All other staff were blinded to medication assignments. The sham injection was a needlestick using the exenatide multi-dose syringe with no drug injected. Note that the volume of fluid injected for a 5mcg dose was only .08ml. It is not expected that subjects would sense this volume of fluid (or lack thereof) during the injection. Subjects were shielded from seeing the injection to maintain the blind. The individual who administered medication did not participate in subject evaluation to maintain the study blind.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, randomized, placebo-controlled, crossover design trial that tested the effect of exenatide on alcohol self-administration and craving following a priming dose of alcohol.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 24, 2018
• Study Start: May 2, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 9, 2022
• Results First Posted: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)