The use of citalopram in treating alcoholic subtypes

ISRCTN ISRCTN71221969
DOI https://doi.org/10.1186/ISRCTN71221969
Secondary identifying numbers MCT-59634
Submission date
26/09/2005
Registration date
26/09/2005
Last edited
17/11/2009
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 Dara Alexandra Charney
Scientific

McGill University Health Centre
Addictions Unit
1604 Pine Avenue West
Montreal
H3G 1B4
Canada

Phone +1 514 934 8311
Email dara.charney@mcgill.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAlcohol use disorders: clinical and biological predictors of treatment outcome
Study objectivesPrimary 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(s)McGill University Health Centre, Clinical Trials Committee, MUHC - Montreal General Hospital, Montreal, QC gave approval on the 6th September 2002
Health condition(s) or problem(s) studiedAlcohol use disorders
InterventionCitalopram 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Citalopram
Primary outcome measureAll 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 measuresAll 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 study start date01/10/2002
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants389
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment01/10/2002
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

McGill University Health Centre
Montreal
H3G 1B4
Canada

Sponsor information

The Research Institute, McGill University Health Centre (Canada)
Research organisation

1650 Cedar Ave, Room S2-214
Montreal
H3G 1A4
Canada

Website http://www.muhc.ca/
ROR logo "ROR" https://ror.org/04cpxjv19

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59634)

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