Saracatinib and Alcohol Drinking

NCT02955186 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 16010170432P50AA012870-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Day 8 Adlib

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

  Day 8 Adlib

Study Arms (2)

125 mg saracatinib

EXPERIMENTAL

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

Drug: Saracatinib

Placebo

PLACEBO COMPARATOR

Participants will take placebo daily for 8 days.

Drug: Placebos

Interventions

Saracatinib DRUG

Saracatinib 125 mg once per day for 8 days

Also known as: AZD0530

125 mg saracatinib

Placebos DRUG

Placebo once per day for 8 days

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 21-50
• Able to read English at 6th grade level or higher and to complete study evaluations
• Regular alcohol drinker

You may not qualify if:

• Individuals who are seeking alcohol treatment
• Medical conditions that would contraindicate the use of saracatinib
• Regular use of other substances

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Dana Cavallo, Project Coordinator
• Organization: Yale School of Medicine

dana.cavallo@yale.edu

203-610-9788

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 4, 2016
• Study Start: May 9, 2017
• Primary Completion: April 24, 2019
• Study Completion: June 7, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Locations

US (1)