Does Acamprosate Decrease Cue-induced Alcohol Craving?

ISRCTN	ISRCTN74707125
DOI	https://doi.org/10.1186/ISRCTN74707125
Clinical Trials Information System (CTIS)	2004-004514-17
Protocol serial number	EudraCT number: 2004-004514-17
Sponsor	Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Funders	AFA insurances (AFA försäkringar) (Sweden) - http://www.afaforsakring.se, Systembolagets Council for Alcohol Research (Systembolagets råd för alkoholforskning) (Sweden) - http://www.can.se/sa/node.asp?node=1663, Milan Valverius Foundation (Sweden) - http://www.salusansvar.se/info/default.aspx?FolderID=3063a24d-26b2-416d-b00a-1d4d06810b2e, Foundation for Research on Psychiatric Diseases (Psykiatrifonden) (Sweden) - http://www.psykiatrifonden.se

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

Primary study design	Interventional
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
Secondary study design	Randomised controlled trial
Scientific title	A randomised placebo-controlled trial of acamprosate effects on alcohol cue reactivity and alcohol priming in dependent patients
Study acronym	DADCAC
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Acamprosate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	05/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	56
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	05/02/2007

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Clinical Neuroscience

Stockholm
17176
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan