Aversive reaction during alcohol cue exposure in Alcoholic Intoxication, Chronic - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Alcoholic Intoxication, Chronic

Intervention / Treatment

Behavioral: Aversive reaction during alcohol cue exposure

Detailed Description

The efficacy of disulfiram in relapse prevention is controversial. Not only are most of the studies dated but their methodological rigor is generally poor. The major obstacle to disulfiram's effectiveness is non-compliance. No study to date has directly explored whether the threat of a disulfiram ethanol reaction (DER), provoked by the ingestion of disulfiram, has an effect on craving. Alcohol dependent patients have difficulty tolerating craving, a phenomenon that is believed to increase the probability of relapse. We propose in this study an evaluation of alcohol craving in relation to the threat of a DER compared to no threat. In both of these experimental conditions, we will use a placebo in order to avoid confounding the pharmacological effect of disulfiram with the psychological effect of the threat. Craving will be evaluated in the context of the multidimensional model of ambivalence (BREINER, STRITZKE and Lang, 1999) which provides two independent dimensions, craving and aversion.

To evaluate the effect of the threat of an aversive reaction on the response during alcohol cue exposure in alcohol dependent patients : (1) the subjective response (craving) and (2) the physiological response (heart rate and blood pressure).

To evaluate the correlation between the subjective and physiological responses to alcohol cue exposure in relation to the threat of an aversive reaction.
To evaluate the moderating effects of mood and personality on alcohol cue exposure in relation to the threat of an aversive reaction.

The design of this study is a within-subject, single-blind, randomized, and monocentric. The participants will be exposed to their habitual alcoholic drink. They will receive a placebo with two types of randomized inductions : (1) the threat of an aversive reaction and (2) no threat. The initial inclusion visit will take place a minimum of six days after the patients consumed their last alcohol beverage, the first cue exposure will take place one to seven days after the inclusion visit, and the second cue exposure will take place four to eight days after the first. This study directly benefits the patient because the experience of cue exposure provokes habituation.

The demonstration of an effect of the threat of an aversive reaction on craving may help alcohol dependent patients to better accept treatment using disulfiram as they would view it as alleviating craving instead of strictly as a punitive measure in the event of alcohol intake.

Study Type

Interventional

Enrollment (Actual)

30

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Limeil-Brevannes, France, 94450
    - Hôpital Emile Roux APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inpatients
Alcohol dependence
Detoxified since at least one week
Willing to abstain from alcohol for at least 6 months
Never treated with disulfiram

Exclusion Criteria:

Any contra-indication to disulfiram
Treated with and antidepressant or a neuroleptic medication within the 30 previous days
Treated with acamprosate, naltrexone, betablockers or clonidine within the 7 previous days
Treated with benzodiazepines within the 3 previous days (except diazepam, maximum 30 mg/d)
Anosmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol craving visual analogic evaluation Time Frame: during de study	Alcohol craving visual analogic evaluation	during de study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure and Pulse Rate Time Frame: during the study	Blood Pressure and Pulse Rate	during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut de Recherches Scientifiques sur les Boissons

Investigators

Principal Investigator: Henri Jean AUBIN, MD,, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Skinner MD, Coudert M, Berlin I, Passeri E, Michel L, Aubin HJ. Effect of the threat of a disulfiram-ethanol reaction on cue reactivity in alcoholics. Drug Alcohol Depend. 2010 Dec 1;112(3):239-46. doi: 10.1016/j.drugalcdep.2010.06.011. Epub 2010 Aug 13.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria