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Alcoholic Intoxication, ChronicNCT00372749

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

A study testing Aversive reaction during alcohol cue exposure in people with Alcoholic Intoxication, Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholic Intoxication, Chronic
What is being tested?
Aversive reaction during alcohol cue exposure
How many people
30 participants
Where
1 siteFrance
Study dates
Oct 2006to Mar 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inpatients
  • Alcohol dependence
  • Detoxified since at least one week
  • Willing to abstain from alcohol for at least 6 months
  • Never treated with disulfiram

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Emile Roux APHP

    Limeil-Brévannes, 94450

Other trials in France

About this study

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).

Read the 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.

Being tested
Aversive reaction during alcohol cue exposure
Keywords
Alcohol dependence, Craving, Disulfiram, Cue exposure
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aversive reaction during alcohol cue exposureBehavioural

    Aversive reaction during alcohol cue exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol craving visual analogic evaluation

    Alcohol craving visual analogic evaluation

    Measured: during de study

Secondary outcomes (1)
  1. Blood Pressure and Pulse Rate

    Blood Pressure and Pulse Rate

    Measured: during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00372749
Sponsor's protocol ID
P051058
Status last verified
Feb 2007
First submitted
5 Sep 2006
Last updated
28 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20708858

Questions about this trial

What is this clinical trial studying?

A study testing Aversive reaction during alcohol cue exposure in people with Alcoholic Intoxication, Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol craving visual analogic evaluation (time frame: during de study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00372749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.

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