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
Scientific
Department of Clinical Neuroscience
Section for Alcohol and Drug dependence Research
Karolinska University Hospital, M4:02
Stockholm
17176
Sweden
johan.franck@ki.se |
Study information
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 |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Acamprosate |
Primary outcome measure | 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 study start date | 01/09/2005 |
Completion date | 05/02/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
17176
Sweden
Sponsor information
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Box 17914
Stockholm
118 95
Sweden
Website | http://www.beroendecentrum.com |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |