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Saracatinib and Alcohol Drinking

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ClinicalTrials.gov Identifier: NCT02955186
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, 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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: Saracatinib Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Fyn Kinase Inhibitors and Alcohol Drinking
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: 125 mg saracatinib
Participants will take 125 mg of saracatinib daily for 8 days.
Drug: Saracatinib
Saracatinib 125 mg once per day for 8 days
Other Name: AZD0530

Placebo Comparator: Placebo
Participants will take placebo daily for 8 days.
Drug: Placebos
Placebo once per day for 8 days




Primary Outcome Measures :
  1. Number of Drinks Consumed on Day 8 [ Time Frame: Day 8 ]
    Number of drinks consumed on Day 8

  2. Baseline adjusted Craving (YCS) [ Time Frame: Day 8 ]
    Craving for alcohol based on Yale Craving Scale, 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 :
  1. Stimulation and Sedation Responses to Alcohol (BAES) [ Time Frame: Day 8 ]
    Biphasic Alcohol Effects Scale scores will be used to assess stimulation and sedation



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955186


Locations
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United States, Connecticut
CMHC, Substance Abuse Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University

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Responsible Party: Suchitra Krishnan-Sarin, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02955186     History of Changes
Other Study ID Numbers: 1601017043
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action