Condition category
Mental and Behavioural Disorders
Date applied
13/11/2007
Date assigned
18/01/2008
Last edited
21/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johan Franck

ORCID ID

Contact details

Department of Clinical Neuroscience
Section for Alcohol and Drug dependence Research
Karolinska University Hospital
M4:02
Stockholm
17176
Sweden
johan.franck@ki.se

Additional identifiers

EudraCT number

2004-004514-17

ClinicalTrials.gov number

Protocol/serial number

EudraCT number: 2004-004514-17

Study information

Scientific title

A randomised placebo-controlled trial of acamprosate effects on alcohol cue reactivity and alcohol priming in dependent patients

Acronym

DADCAC

Study hypothesis

1. Acamprosate attenuates cue-induced subjectively experienced and physiolological correlates of craving
2. Acamprosate attenuates alcohol-induced subjectively experienced and physiolological correlates of craving

Ethics approval

The trial was approved by:
1. The Regional Ethical Review Board in Stockholm on the 23rd March 2005 (ref: 2005/30-31/3)
2. The Swedish Medical Products Agency on the 5th April 2005 (EudraCT number: 2004-004514-17)

Study design

The study used a randomised, double blind, single-site, placebo-controlled design comparing cue- and alcohol-induced craving for acamprosate and placebo treated patients

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Alcohol dependence

Intervention

Patients were assigned to 22 days of either acamprosate (1998 mg/day) or placebo treatment according to a randomisation process conducted by the Karolinska University Hospital pharmacy. Medication (150 tablets containing 333 mg acamprosate or placebo) was dispensed once per patient, at the start of the trial, with instructions to intake 6 tablets per day (2 in AM, 2 midday, 2 in PM).

Intervention type

Drug

Phase

Not Specified

Drug names

Acamprosate

Primary outcome measures

1. The difference in subjectively experienced craving post exposure to non-alcohol related stimuli versus alcohol related stimuli
2. The difference in subjectively experienced craving between pre- and post-consumption of an alcoholic drink

For both measures comparisons are made between acamprosate versus placebo treated patients. Measures are collected post 22 days of treatment. Patients then come to the clinic and go through a series of sessions where they are exposed to alcohol versus non-alcohol related stimuli, and also take part in a alcohol priming paradigm. Present alcohol craving is measured in connection to each exposure.

Secondary outcome measures

Physiological measures of craving:
1. Pulse
2. Blood-pressure
3. Cortisol in blood
4. Galvanic skin response
5. Skin temperature

Measures are collected post 22 days of treatment. Patients then come to the clinic and go through a series of sessions where they are exposed to alcohol versus non-alcohol related stimuli, and also take part in an alcohol priming paradigm. Present alcohol craving is measured in connection to each exposure.

Overall trial start date

01/09/2005

Overall trial end date

05/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. A male or a non-pregnant/non-nursing female between 18 and 65 years of age
2. A goal of controlled drinking
3. An intact sense of smell
4. Fulfilling the criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
5. Willingness to give informed consent and comply with study procedures
6. Alcohol consumption in 15 of the last 90 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant exclusion criteria

1. Seeking complete alcohol abstinence
2. Current use of any medication that interferes with salivation
3. A diagnosis of an Axis I psychiatric disorder according to DSM-IV criteria (including all forms of substance dependence other than nicotine and alcohol)
4. A current use of psychoactive medications to manage schizophrenia, bipolar disorder, or major depression
5. Inpatient alcohol detoxification within the last 4 days
6. Acamprosate medication during the last year
7. Use of illegal drugs during the course of the study

Recruitment start date

01/09/2005

Recruitment end date

05/02/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Clinical Neuroscience
Stockholm
17176
Sweden

Sponsor information

Organisation

Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)

Sponsor details

Box 17914
Stockholm
118 95
Sweden

Sponsor type

Hospital/treatment centre

Website

http://www.beroendecentrum.com

Funders

Funder type

Research organisation

Funder name

AFA insurances (AFA försäkringar) (Sweden) - http://www.afaforsakring.se

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Systembolagets Council for Alcohol Research (Systembolagets råd för alkoholforskning) (Sweden) - http://www.can.se/sa/node.asp?node=1663

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Milan Valverius Foundation (Sweden) - http://www.salusansvar.se/info/default.aspx?FolderID=3063a24d-26b2-416d-b00a-1d4d06810b2e

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for Research on Psychiatric Diseases (Psykiatrifonden) (Sweden) - http://www.psykiatrifonden.se

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes