Phase 2 N=50 Randomized Triple-blind Other

Saracatinib and Alcohol Drinking

Alcohol Drinking

Bottom Line

View on ClinicalTrials.gov: NCT02955186 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Nov 2020

Primary outcome: Primary: Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) — -1.85; -2.33 drinks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Saracatinib (Drug); Placebos (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)	-1.85; -2.33	—
PRIMARY Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS	3133; 2876	—
SECONDARY Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)	1650.8; 1607.1	—
SECONDARY Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)	1149.9; 515.29	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02955186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.