Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers

Status Completed

Clinical Trial Summary

Clinical Trial Description

The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.

Subjects will participate in two lab sessions, one prior to taking medication and one following 8-11 days of AZD0530. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.

Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530, as well as no difference in behavioral or cognitive responses to alcohol in the presence of AZD0530, the investigators will begin the pilot study examining the effects of two doses of AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those obtained from historical controls who were treated with placebo in Study 1. Subjects will be randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects factor. ;

Study Design

Related Conditions & MeSH terms

Alcohol Drinking

Clinical Trial Details

NCT number	NCT02732587
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	Phase 1
Start date	November 2015
Completion date	March 23, 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05414344` - A Brief Intervention for Alcohol Users With Interpersonal Trauma	N/A
Completed	`NCT05521906` - Evaluation of PRYSHM for LGBTQIA2S+ Youth	N/A
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn	`NCT04659278` - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use	N/A
Not yet recruiting	`NCT03632408` - Hangover and Residual Zopiclone Effect on Spatial Perception	Phase 1
Completed	`NCT02718508` - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use	N/A
Active, not recruiting	`NCT02629679` - Sports, Education and Consumption of Substances in Adolescents	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Completed	`NCT01442753` - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth	N/A
Completed	`NCT01081119` - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth	Phase 2
Completed	`NCT00289965` - Substance Use Risk Education (SURE) Project	Phase 2
Completed	`NCT04510116` - Adults In The Making Prevention Trial	N/A
Completed	`NCT00506753` - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail	N/A
Recruiting	`NCT05288790` - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT	Phase 2
Recruiting	`NCT05620849` - Young Adult Education on Alcohol & Health	N/A
Recruiting	`NCT03588754` - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?	Phase 2
Recruiting	`NCT04054466` - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART	N/A
Recruiting	`NCT06074341` - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study	N/A
Terminated	`NCT04596267` - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.