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

This study has been completed.
Sponsor:
Collaborator:
Institut de Recherches Scientifiques sur les Boissons
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00372749
First received: September 5, 2006
Last updated: March 25, 2011
Last verified: February 2007

September 5, 2006
March 25, 2011
October 2006
March 2009   (final data collection date for primary outcome measure)
Alcohol craving visual analogic evaluation [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
Alcohol craving visual analogic evaluation
Alcohol craving visual analogic evaluation
Complete list of historical versions of study NCT00372749 on ClinicalTrials.gov Archive Site
Blood Pressure and Pulse Rate [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Blood Pressure and Pulse Rate
Blood Pressure and Pulse Rate
Not Provided
Not Provided
 
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Alcoholic Intoxication, Chronic
Behavioral: Aversive reaction during alcohol cue exposure
Aversive reaction during alcohol cue exposure
Other Name: Aversive reaction during alcohol cue exposure
Not Provided
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. Epub 2010 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00372749
P051058
Yes
Myriem CARRIER, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Institut de Recherches Scientifiques sur les Boissons
Principal Investigator: Henri Jean AUBIN, MD, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP