Saracatinib and Alcohol Drinking

Study Overview
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Brief Summary
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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.

Official Title
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Fyn Kinase Inhibitors and Alcohol Drinking

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: Saracatinib
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 125 mg saracatinib<br>Participants will take 125 mg of saracatinib daily for 8 days. | Drug: Saracatinib<br>* Saracatinib 125 mg once per day for 8 days<br>* Other names: AZD0530;|
| Placebo Comparator: Placebo<br>Participants will take placebo daily for 8 days. | Drug: Placebos<br>* Placebo once per day for 8 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |