Does Acamprosate Decrease Cue-induced Alcohol Craving?

ISRCTN ISRCTN74707125
DOI https://doi.org/10.1186/ISRCTN74707125
EudraCT/CTIS number 2004-004514-17
Secondary identifying numbers EudraCT number: 2004-004514-17
Submission date
13/11/2007
Registration date
18/01/2008
Last edited
21/01/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Johan Franck
Scientific

Department of Clinical Neuroscience
Section for Alcohol and Drug dependence Research
Karolinska University Hospital, M4:02
Stockholm
17176
Sweden

Email johan.franck@ki.se

Study information

Study designThe 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised placebo-controlled trial of acamprosate effects on alcohol cue reactivity and alcohol priming in dependent patients
Study acronymDADCAC
Study objectives1. 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(s)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)
Health condition(s) or problem(s) studiedAlcohol dependence
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Acamprosate
Primary outcome measure1. 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 measuresPhysiological 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 study start date01/09/2005
Completion date05/02/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants56
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2005
Date of final enrolment05/02/2007

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Clinical Neuroscience
Stockholm
17176
Sweden

Sponsor information

Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Hospital/treatment centre

Box 17914
Stockholm
118 95
Sweden

Website http://www.beroendecentrum.com
ROR logo "ROR" https://ror.org/04g380834

Funders

Funder type

Research organisation

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

No information available

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

No information available

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan