Alcoholic Intoxication, Chronic Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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