search
Back to results

Saracatinib and Alcohol Drinking

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saracatinib
Placebos
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Drinking

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMHC, Substance Abuse Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

125 mg saracatinib

Placebo

Arm Description

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

Participants will take placebo daily for 8 days.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 1, 2016
Last Updated
October 20, 2020
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02955186
Brief Title
Saracatinib and Alcohol Drinking
Official Title
Fyn Kinase Inhibitors and Alcohol Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
June 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
125 mg saracatinib
Arm Type
Experimental
Arm Description
Participants will take 125 mg of saracatinib daily for 8 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take placebo daily for 8 days.
Intervention Type
Drug
Intervention Name(s)
Saracatinib
Other Intervention Name(s)
AZD0530
Intervention Description
Saracatinib 125 mg once per day for 8 days
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo once per day for 8 days
Primary Outcome Measure Information:
Title
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
Description
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).
Time Frame
Baseline and Day 8
Title
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS
Description
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.
Time Frame
Baseline and Day 7
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)
Description
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.
Time Frame
Day 8 Adlib
Title
Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)
Description
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.
Time Frame
Day 8 Adlib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CMHC, Substance Abuse Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Saracatinib and Alcohol Drinking

We'll reach out to this number within 24 hrs