Condition category
Mental and Behavioural Disorders
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
17/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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. John’s 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

http://www.muhc.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes