Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372749
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2006-09-05
Brief Title:
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 disulfirams 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None