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
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