Primary outcomeMean· 2 hours
Alcohol Consumption
| Group | Value (standard drink units (SDUs)) | Spread |
|---|---|---|
| Exenatide Injection | 0.93 | 0.87 |
| Sham Injection (Placebo) | 2.78 | 2.66 |
Trial · Interventional
TerminatedPhase 1Results postedRegistry dataThe Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers
This trial was stopped early.
Reason given at the registry: Due to COVID-19 hospital-wide policies halting recruitment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 1
- Enrollment
- 8 participants (actual)
- Sponsor
- Boston Medical Center · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 2 May 2019
- Primary completion
- 1 Jul 2021
- Completion
- 1 Jul 2021
- First posted
- 24 Aug 2018
- Last update posted
- 9 Feb 2022
- Conditions
- Alcohol Use Disorder
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2019202020212022
- Ph 1Terminated
The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers
NCT036454082 May 2019 to 1 Jul 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- Sham injectionOther
Arms2
Experimental
Exenatide then Placebo
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.
Experimental
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 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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Alcohol Consumption
Time frame · 2 hours
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideSubjects received a 5 mcg dose of immediate-release exenatide on the day of the alcohol self-administration trial. This is a within subjects design study in which each subject received both study drug and sham injection (placebo). 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. | 0 / 3 | 0 / 3 | 1 / 3 |
| Sham Injection (Placebo)Subjects received a sham injection on the day of the alcohol self-administration trial. This is a within subjects design study in which each subject received both study drug and sham injection (placebo). 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. | 0 / 3 | 0 / 3 | 1 / 3 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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 \[4 standard drink units (SDUs) for women or 21 SDUs for men per week\]
4. 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.
5. Meets Diagnostic And Statistical Manual Of Mental Disorders, Fifth Edition (DSM-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. BMI is less than 18 or greater than or equal to 30.
10. History of diabetes.
11. Baseline hemoglobin A1c ≥ 6.5%
12. Baseline non fasting 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 AUD in the past 90 days.
19. Has taken medications that are used to treat alcohol use disorder (AUD) 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.
26. 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.).
27. Subject has prior history of Drug-induced thrombocytopenia
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