Contact information
Type
Scientific
Primary contact
Dr Dara Alexandra Charney
ORCID ID
Contact details
McGill University Health Centre
Addictions Unit
1604 Pine Avenue West
Montreal
H3G 1B4
Canada
+1 514 934 8311
dara.charney@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-59634
Study information
Scientific title
Alcohol use disorders: clinical and biological predictors of treatment outcome
Acronym
Study hypothesis
Primary hypothesis:
Initial treatment with citalopram improves early treatment outcome (e.g. reduces early dropouts, increases duration of abstinence, decreases number of drinking days and/or mean number of drinks per drinking day) among alcoholic patients.
Secondary hypotheses:
1. Depression at intake into addiction treatment, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for a current diagnosis of major depression, is a significant positive predictor of response to citalopram (in terms of drinking-related measures), and a significant negative predictor of overall treatment outcome
2. Abnormal serotonin functioning, as measured by high 5HT uptake in platelets, and the presence of the long variant of the SERT promoter is a significant positive predictor of response to citalopram (in terms of drinking-related measures), and a significant negative predictor of overall treatment outcome
As of 25/03/2009 this record was updated to include an updated anticipated end date; the initial anticipated end date was 30/09/2007.
Ethics approval
McGill University Health Centre, Clinical Trials Committee, MUHC - Montreal General Hospital, Montreal, QC gave approval on the 6th September 2002
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Alcohol use disorders
Intervention
Citalopram 40 mg orally (po) once a day (QD) versus placebo for 12 weeks. Both groups receive the standard addiction treatment (weekly individual and group psychotherapy) for 12 weeks.
Trial details received: 12 Sept 2005
Intervention type
Drug
Phase
Not Applicable
Drug names
Citalopram
Primary outcome measure
All planned outcomes are measured at 12 weeks, as follows:
1. Percentage change in number of drinking days
2. Percentage change in mean number of drinks per drinking day
3. Maximum duration of continuous abstinence
4. Percentage change in ASI alcohol/drug composite scores
5. Time spent in treatment (retention)
6. Time to first relapse
Secondary outcome measures
All secondary outcomes are measured at 12 weeks:
1. Utilisation of treatment resources (e.g. number of individual/group therapy sessions attended, number of psychiatric appointments, hospitalisation, etc.)
2. Percentage change in number of drinking days
3. Percentage change in depression scores (e.g. Beck Depression Inventory [BDI], Hamilton Rating Scale for Depression [Ham-D], Symptom Checklist [SCL] subscale, etc.)
4. Percentage change in anxiety scores (e.g. Beck Anxiety Inventory [BAI], SCL subscale, etc.)
5. Percentage change in impulsivity scores (e.g. BIS total and subscales)
6. Results of random urine toxicology screening
7. Time to first relapse
Overall trial start date
01/10/2002
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women and men between 18 and 65 years of age
2. Who request treatment at the Addictions Unit
3. Who suffer from alcohol abuse or dependence (as per DSM-IV diagnostic criteria)
4. Who can be contacted reliably
5. Who have signed the consent form (as approved by the local Clinical Trials Committee)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
389
Participant exclusion criteria
1. If they currently suffer from another substance dependence, excluding nicotine (as per DSM-IV diagnostic criteria)
2. If they are likely to suffer severe alcohol withdrawal symptoms necessitating hospitalisation (as per American Society of Addiction Medicine guidelines for inpatient alcohol detoxification)
3. If they currently suffer from schizophrenia, schizoaffective disorder, or bipolar disorder
4. If they are currently experiencing psychotic symptoms or suicidal ideation (as determined by clinical interviews by the RA and an Addictions Unit psychiatrist)
5. If they are taking or have taken a serotonergic agent in the two weeks prior to enrolment in the study (four weeks in the case of fluoxetine) e.g. any antidepressant medication, including SSRIs, tricyclic antidepressants, MAO inhibitors, and St. Johns Wort; any mood stabilizer, including carbamazepine, lamotrigine, lithium, and valproate; any antipsychotic medication, including conventional and novel antipsychotics etc.
6. If a female patient is pregnant or breast-feeding - NB women of childbearing potential must be practicing an effective method of birth control while participating in this study, and must agree not to become pregnant during their participation in this study
7. If they have a history of serious adverse reactions or intolerance of selective serotonin reuptake inhibitors (SSRIs)
Recruitment start date
01/10/2002
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
McGill University Health Centre
Montreal
H3G 1B4
Canada
Sponsor information
Organisation
The Research Institute, McGill University Health Centre (Canada)
Sponsor details
1650 Cedar Ave
Room S2-214
Montreal
H3G 1A4
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59634)
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
Basic results (scientific)
Publication list