Alcohol use disorders Mental and Behavioural Disorders Alcohol dependency
Conditions
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
Sponsors
The Research Institute, McGill University Health Centre (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
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)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed