Charney 2015.
Methods | Design: placebo‐controlled parallel trial |
Participants |
Participants: outpatients with alcohol abuse or dependence Sex: 80 female, 185 male Age: 18‐65 (placebo mean age = 44.7 years; citalopram mean age = 46.0 years) Unit of allocation: individual participant Number randomised: 265 (citalopram = 138, placebo = 127) Number completing:141 (citalopram = 72, placebo = 69) Setting: outpatient: specialist addiction unit in Canada Inclusion criteria: DSM‐IV diagnosis of alcohol abuse or dependence Exclusion criteria: having a second substance use disorder (other than nicotine dependence); psychotic or organic brain disorder; taking any psychiatric medications including SSRI; requiring inpatient detoxification or psychiatric admission; pregnant or breastfeeding; history of serious adverse reactions or intolerance to SSRIs Ethnicity: 92% Caucasian |
Interventions | Two conditions (citalopram + TAU and placebo + TAU)
Duration of intervention: 12 weeks Duration of trial: 12 weeks Length of follow‐up: none Dose adjustment: citalopram started at 20 mg per day for first week; from week 2 to week 12 citalopram administered at 40 mg per day; same number of capsules provided to the two groups |
Outcomes |
Primary outcomes None reported Secondary outcomes Leaving the study early: n withdrawn for medical reasons; n discontinued intervention Substance misuse: Addiciton Severity Index (ASI); urine samples for toxicology analysis (cloned enzyme donor immunoassay); number of days alcohol intake; number of drinks per drinking day; Can$ spent on alcohol; max number of days abstinent; abstinent at 12 weeks Impulsivity: Barratt Impulsiveness Scale (BIS) Mental State: Hamilton Rating Scale for Depression (HAM‐D); Clinical Global Impression Scale (CGI); Axis‐1 disorders using SCID‐I; Personality disorders using SCID‐II; Beck Depression Inventory (BDI); Beck Anxiety Inventory (BAI); Symptom checklist (SCL‐90) Other outcomes None reported |
Notes | Email correspondence with author (KG) on 17 January 2017 (see Charney 2015) who confirmed no AsPD data available: "No, not possible to do this breakdown for now. We did the analyses by clusters, since there were too few of each PD to analyse separately. Sorry about this..." (quote) |
ASI = Addiction Severity Index; AsPD = antisocial personality disorder; BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory; BIS = Barratt Impulsiveness Scale; CGI = Clinical Global Impression; DSM‐III‐R = Diagnostic and Statistical Manual of Mental Disorders, Third Edition–Revised; HAM‐D = Hamilton Depression Rating scale; RCT: randomised controlled trial; SCID‐I = Structured Clinical Interview for DSM‐IV Axis 1 disorders; SCID‐II = Structured Clinical Interview for DSM‐IV; SCL‐90 = Symptom Check List‐90; SD = standard deviation; SSRI = selective serotonin reuptake inhibitor; TAU = treatment as usual.