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| [ Print-friendly version ] |
| The use of citalopram in treating alcoholic subtypes |
| ISRCTN | ISRCTN71221969 |
| ClinicalTrials.gov identifier | |
| Public title | The use of citalopram in treating alcoholic subtypes |
| Scientific title | Alcohol use disorders: clinical and biological predictors of treatment outcome |
| Acronym | N/A |
| Serial number at source | MCT-59634 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Alcohol use disorders |
| Participants - 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) |
| Participants - 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) |
| Anticipated start date | 01/10/2002 |
| Anticipated end date | 01/12/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 389 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59634) |
| Trial website | |
| Publications | |
| Contact name | Dr Dara Alexandra Charney |
| Address |
McGill University Health Centre
Addictions Unit 1604 Pine Avenue West |
| City/town | Montreal |
| Zip/Postcode | H3G 1B4 |
| Country | Canada |
| Tel | +1 514 934 8311 |
| Fax | +1 514 934 8262 |
| dara.charney@mcgill.ca | |
| Sponsor | The Research Institute, McGill University Health Centre (Canada) |
| Address | 1650 Cedar Ave, Room S2-214 |
| City/town | Montreal |
| Zip/Postcode | H3G 1A4 |
| Country | Canada |
| Sponsor website: | http://www.muhc.ca/ |
| Date applied | 26/09/2005 |
| Last edited | 17/11/2009 |
| Date ISRCTN assigned | 26/09/2005 |
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