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Saracatinib and Alcohol Drinking

NCT ID: NCT02955186

Last Updated: 2020-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2019-06-07

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.

Detailed Description

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Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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125 mg saracatinib

Participants will take 125 mg of saracatinib daily for 8 days.

Group Type EXPERIMENTAL

Saracatinib

Intervention Type DRUG

Saracatinib 125 mg once per day for 8 days

Placebo

Participants will take placebo daily for 8 days.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo once per day for 8 days

Interventions

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Saracatinib

Saracatinib 125 mg once per day for 8 days

Intervention Type DRUG

Placebos

Placebo once per day for 8 days

Intervention Type DRUG

Other Intervention Names

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AZD0530

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Suchitra Krishnan-Sarin

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CMHC, Substance Abuse Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2P50AA012870-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1601017043

Identifier Type: -

Identifier Source: org_study_id