Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
Primary Purpose
Alcoholic Intoxication, Chronic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aversive reaction during alcohol cue exposure
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Intoxication, Chronic focused on measuring Alcohol dependence, Craving, Disulfiram, Cue exposure
Eligibility Criteria
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
Sites / Locations
- Hopital Emile Roux APHP
Outcomes
Primary Outcome Measures
Alcohol craving visual analogic evaluation
Alcohol craving visual analogic evaluation
Secondary Outcome Measures
Blood Pressure and Pulse Rate
Blood Pressure and Pulse Rate
Full Information
NCT ID
NCT00372749
First Posted
September 5, 2006
Last Updated
March 25, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut de Recherches Scientifiques sur les Boissons
1. Study Identification
Unique Protocol Identification Number
NCT00372749
Brief Title
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
Official Title
Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut de Recherches Scientifiques sur les Boissons
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Intoxication, Chronic
Keywords
Alcohol dependence, Craving, Disulfiram, Cue exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Aversive reaction during alcohol cue exposure
Intervention Description
Aversive reaction during alcohol cue exposure
Primary Outcome Measure Information:
Title
Alcohol craving visual analogic evaluation
Description
Alcohol craving visual analogic evaluation
Time Frame
during de study
Secondary Outcome Measure Information:
Title
Blood Pressure and Pulse Rate
Description
Blood Pressure and Pulse Rate
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Jean AUBIN, MD,
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Emile Roux APHP
City
Limeil-Brevannes
ZIP/Postal Code
94450
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20708858
Citation
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. doi: 10.1016/j.drugalcdep.2010.06.011. Epub 2010 Aug 13.
Results Reference
derived
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Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
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