Clinical Trial: Saracatinib and Alcohol Drinking

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Fyn Kinase Inhibitors and Alcohol Drinking

Brief Summary: The purpose of this study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome:

  • Number of Drinks Consumed on Day 8 [ Time Frame: Day 8 ]
    Number of drinks consumed on Day 8
  • Baseline adjusted Craving (YCS) [ Time Frame: Day 8 ]
    Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.


Original Primary Outcome: Same as current

Current Secondary Outcome: Stimulation and Sedation Responses to Alcohol (BAES) [ Time Frame: Day 8 ]

Biphasic Alcohol Effects Scale scores will be used to assess stimulation and sedation


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: November 1, 2016
Date Started: January 2017
Date Completion: June 2021
Last Updated: May 24, 2017
Last Verified: May 2017