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Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?

2014-08-27 03:42:42 | BioPortfolio

Summary

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).

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Alcohol Dependence

Intervention

Aversive reaction during alcohol cue exposure

Location

Hopital Emile Roux APHP
Limeil-Brevannes
France
94450

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:42-0400

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Medical and Biotech [MESH] Definitions

The process of converting an acid into an alkyl or aryl derivative. Most frequently the process consists of the reaction of an acid with an alcohol in the presence of a trace of mineral acid as catalyst or the reaction of an acyl chloride with an alcohol. Esterification can also be accomplished by enzymatic processes.

Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism.

Phospholipids which have an alcohol moiety in ethereal linkage with a saturated or unsaturated aliphatic alcohol. They are usually derivatives of phosphoglycerols or phosphatidates. The other two alcohol groups of the glycerol backbone are usually in ester linkage. These compounds are widely distributed in animal tissues.

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A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)

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