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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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 t
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Alcohol craving visual analogic evaluation [ Time Frame: during de study ]

Alcohol craving visual analogic evaluation


Original Primary Outcome: Alcohol craving visual analogic evaluation

Current Secondary Outcome: Blood Pressure and Pulse Rate [ Time Frame: during the study ]

Blood Pressure and Pulse Rate


Original Secondary Outcome: Blood Pressure and Pulse Rate

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 5, 2006
Date Started: October 2006
Date Completion:
Last Updated: March 25, 2011
Last Verified: February 2007