Saracatinib and Alcohol Drinking

Phase 2

Completed

• Conditions: Alcohol Drinking
• Interventions: Drug: Placebos; Drug: Saracatinib

• Registration Number: NCT02955186
• Lead Sponsor: Yale University

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-04
• Study Start: 2017-05-09
• Primary Completion: 2019-04-24
• Study Completion: 2019-06-07
• Results First Submitted: 2020-04-23
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Results First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Ages 21-50
• Able to read English at 6th grade level or higher and to complete study evaluations
• Regular alcohol drinker

Exclusion Criteria

• Individuals who are seeking alcohol treatment
• Medical conditions that would contraindicate the use of saracatinib
• Regular use of other substances

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Participants will take placebo daily for 8 days.
125 mg saracatinib	Saracatinib	Participants will take 125 mg of saracatinib daily for 8 days.

Primary Outcome Measures

Name	Time	Method
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)	Baseline and Day 8	Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS	Baseline and Day 7	Craving for alcohol based on Yale Craving Scale (YCS), 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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)	Day 8 Adlib	Biphasic Alcohol Effects Scale (BAES) scores will be used to assess sedation. The scale ranges from 0-70, with a higher score indicating more sedated.
Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)	Day 8 Adlib	Biphasic Alcohol Effects Scale (BAES) scores will be used to assess stimulation. The scale ranges from 0-70, with a higher score indicating more sedated.

Trial Locations

Locations (1)

CMHC, Substance Abuse Center; 🇺🇸 New Haven, Connecticut, United States