The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers
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|ClinicalTrials.gov Identifier: NCT03645408|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Exenatide Other: Sham injection||Phase 1|
This proposal is intended to answer the call for accelerating drug development by exploring the potential of a glucagon-like peptide-1 (GLP-1) agonist, exenatide, as a candidate medication for the treatment of Alcohol Use Disorder. There is now substantial preclinical evidence that GLP-1 agonists can attenuate behaviors that model both the consumption and seeking of several commonly abused substances including alcohol, cocaine, and nicotine. This study is intended to accelerate medication development for Alcohol Use Disorder by testing a commercially-available and well-tolerated agent at a fraction of the cost of new drug discovery. None of the FDA-approved Alcohol Use Disorder medications or off-label Alcohol Use Disorder medications target this GLP-1 pathway, making exenatide a promising compound for Alcohol Use Disorder drug development.
The primary aim of this study is to test the effects of exenatide on alcohol self-administration and craving among heavy drinkers. In this within-subjects crossover design, 36 heavy drinkers will be randomized to exposure order (exenatide or sham injection) prior to completing two alcohol self-administration trials. Subjects will receive a priming drink of alcohol and will have access to 8 drinks over a 2-hour period. The investigators anticipate that subjects will consume less alcohol following the administration of exenatide compared to when they receive a sham injection. Significant exenatide-induced reductions in drinking will be considered to be an indication that this drug may have value as an Alcohol Use Disorder medication. This study may provide a rationale for phase II randomized controlled trials testing exenatide with a treatment-seeking Alcohol Use Disorder population. These results may also help to spur further clinical investigation of the effects of exenatide and other available GLP-1 agonists on the factors implicated in the regulation of alcohol consumption.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of exenatide on alcohol self-administration and craving following a priming dose of alcohol.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Nursing staff at the general Clinical Research unit will not be blinded to the study medication. These nurses' only role in the study will be providing injections of the study drug. All other staff will be blinded to medication assignments. The sham injection will be a needlestick using the exenatide multi-dose syringe with no drug injected. Note that the volume of fluid injected for a 5mcg dose is only .08ml. It is not expected that subjects will sense this volume of fluid (or lack thereof) during the injection. Subjects will be shielded from seeing the injection to maintain the blind. The individual who administers medication will not participate in subject evaluation to maintain the study blind.|
|Official Title:||The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Exenatide injection
Subjects in this arm will receive a 5 mcg dose of immediate release exenatide on the day of the alcohol challenge. The 5mcg dose of exenatide is approved as the first dose to be administered to patients at the start of their treatment with this drug for FDA-approved indications.
5 mcg dose of immediate release exenatide
Other Name: byetta
Placebo Comparator: Placebo
Subjects in this arm will receive a sham injection on the day of the alcohol challenge. The sham injection will be 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 will sense this volume of fluid (or lack thereof) during the injection. Subjects will be shielded from seeing the injection to maintain the blind.
Other: Sham injection
Subjects will have a sham injection with no study drug
Other Name: Placebo
- Alcohol Consumption [ Time Frame: 4 hours ]Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
- Alcohol Cravings [ Time Frame: 4 hours ]Alcohol craving will be measured by self report with the Visual Analog Scale . The Visual analog scale is a straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. The Participant marks a point on the line that matches their amount of alcohol craving.
- Blood Glucose [ Time Frame: 4 hours ]The proportion of subjects with blood glucose values below 50 mg/dl will be compared within subjects using the McNemar's test. We hypothesize that there will be no difference in blood glucose levels between the alcohol Challenge Trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645408
|Contact: Eric Devine, PhDfirstname.lastname@example.org|
|Contact: Kathleen Reid, MAemail@example.com|
|United States, Massachusetts|
|Boston University Psychiatry Research Center, Clinical Studies Unit||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Eric G Devine, Ph.D. 617-414-1990 firstname.lastname@example.org|
|Principal Investigator:||Eric Devine, PhD||Boston Medical Center|