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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Alcoholic Intoxication, Chronic
- 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.
Alcohol craving visual analogic evaluation
Alcohol craving visual analogic evaluation
Measured: during de study
Secondary outcomes (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.
- First posted7 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Intoxication, ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherches Scientifiques sur les Boissons
- Investigators
- Henri Jean AUBIN, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?
- ClinicalTrials.gov ID
- NCT00372749
- Acronym / sponsor ID
- P051058
- Conditions
- Alcoholic Intoxication, Chronic
- Keywords
- Alcohol dependence, Craving, Disulfiram, Cue exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut de Recherches Scientifiques sur les Boissons
- Study start
- Oct 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients
- Alcohol dependence
- Detoxified since at least one week
- Willing to abstain from alcohol for at least 6 months
- Never treated with disulfiram
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aversive reaction during alcohol cue exposureAversive reaction during alcohol cue exposure | Behavioural | – |
Primary outcome
Alcohol craving visual analogic evaluation
Time frame: during de study
Alcohol craving visual analogic evaluation
1 secondary outcome
Blood Pressure and Pulse Rate
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
- Derived from this study: PubMed 20708858Skinner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri Jean AUBIN, MD, principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.