MedicalResearch.com Interview with:
Megan Ryan M.B.A.
Clinical Program Director, DMD
Technology Development Coordinator
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
MedicalResearch.com: What is the background for this study?
Response: Alcohol use disorder (AUD) has been linked to the dysregulation of the brain stress systems (e.g. corticotropin-releasing factor, glucocorticoids, and vasopressin) creating a negative emotional state leading to chronic relapsing behavior. Several pre-clinical studies have shown that by blocking the V1b receptor with a V1b receptor antagonist, dependence induced compulsive-like alcohol intake is also blocked. This is the first multi-site trial to assess the efficacy of the V1b receptor antagonist novel compound (ABT-436) for the treatment of alcohol dependence.
MedicalResearch.com: What are the main findings?
Response: This double blind, placebo-controlled trial included 144 men and women who met the DSM-IV criteria for alcohol dependence. Interestingly, participants receiving ABT-436 had a significantly greater percentage of days abstinent than those receiving placebo (p =0.037; d = 0.31) but did not differ on other measures of drinking, including the primary outcome measure, percent heavy drinking days. Another interesting finding was that smokers receiving ABT-436 smoked significantly fewer cigarettes per week (p =.046). We also looked at a subpopulation of “high stress” participants and found that those with higher baseline stress responded better to ABT-436 on various drinking outcomes.
MedicalResearch.com: What should readers take away from your report?
Response: Vasopressin plays a significant role in regulating various complex behaviors including compulsive-like alcohol consumption. ABT-436 appears to impact the withdrawal/negative affect stage of the addiction cycle reducing the frequency of drinking but not consumption once drinking is initiated.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future studies targeting the stress system should enrich the study sample with Alcohol use disorder participants who endorse high stress since our subgroup findings suggest this population may be particularly responsive.
MedicalResearch.com: Is there anything else you would like to add?
Response: Alcohol use disorder is a complex and multifaceted disease. It would benefit physicians to have a variety of medication treatment options to offer patients. Continuing to study the underlying mechanisms of AUD and the stages of the addiction cycle is critical in expanding personalized treatment for those affected by this heterogeneous disorder.
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A Phase 2, Double-Blind, Placebo-Controlled Randomized Trial Assessing the Efficacy of ABT-436, a Novel V1b Receptor Antagonist, for Alcohol Dependence.
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