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Completed

NCT Number: NCT02955186

Saracatinib and Alcohol Drinking

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saracatinib

Drug

Saracatinib 125 mg once per day for 8 days

Other names: AZD0530

Placebos

Drug

Placebo once per day for 8 days

Primary outcomes

  1. Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)

    Time frame: 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).

  2. Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS

    Time frame: 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 outcomes

  1. Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)

    Time frame: 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.

  2. Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Fyn Kinase Inhibitors and Alcohol Drinking

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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