Saracatinib and Alcohol Drinking

Alcohol Drinking Clinical Trial

Official title:

Fyn Kinase Inhibitors and Alcohol Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955186
• Other study ID #: 1601017043
• Secondary ID: 2P50AA012870-16
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2017
• Est. completion date: June 7, 2019

Study information

• Verified date: October 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• Saracatinib
Saracatinib 125 mg once per day for 8 days
• Placebos
Placebo once per day for 8 days

Locations

Country	Name	City	State
United States	CMHC, Substance Abuse Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)	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).	Baseline and Day 8
Primary	Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS	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.	Baseline and Day 7
Secondary	Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)	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.	Day 8 Adlib
Secondary	Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)	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.	Day 8 Adlib