Weinstein 2014.
Methods | Randomised, double‐blind, placebo‐controlled trial. 1‐week "induction" with placebo prior to randomisation | |
Participants | Setting: outpatient, Tel Aviv, Israel. Scheduled duration 9 weeks Participants: 52 adults, regular cannabis users, dependent by DSM‐IV Group sizes: 26 in each group Similarity of groups not reported Mean age 32.7 years 75% male Exclusion criteria: dependence on other drugs or alcohol and significant psychiatric disorder |
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Interventions | Group 1: escitalopram 10 mg/day Group 2: placebo Medication for 9 weeks, follow‐up sessions for further 14 weeks. Blinding broken after 9 weeks; participants able to continue open‐label escitalopram use. Participants instructed to stop cannabis use after 4 weeks of medication. Weekly (9 sessions) cognitive‐behaviour (relapse prevention) and MET in combination with medication |
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Outcomes | Number completing treatment, number abstinent, number reporting not taking medication, results of statistical analyses of withdrawal scores Urine samples collected every second week Questionnaires administered to assess anxiety and depression Revised Clinical Institute Withdrawal Assessment Scale adapted for assessment of cannabis withdrawal (score ≥ 10 indicated significant withdrawal) |
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Notes | Funding: research grant (Israeli anti‐drug authority) Authors declared no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "participants were blindly randomized …" Comment: method of sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Quote: "participants were blindly randomized …" Comment: method of allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind stated and only objective outcomes reported which are less likely to be affected by knowledge of group allocation. |
Incomplete outcome data (attrition bias) All outcomes | High risk | High (50%) rate of dropout. Those who did not complete study were younger, and more likely to be daily alcohol drinkers. Non‐completers marginally more depressed, but difference not statistically significant. |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |
DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; DSM‐IV‐TR: Diagnostic and Statistical Manual of Mental Disorders 4th Edition (Text Revision); ICMJE: International Committee of Medical Journal Editors; IV: intravenous; MCQ: Marijuana Craving Questionnaire; MET: motivational enhancement therapy; NIAAA: National Institute on Alcohol Abuse and Alcoholism; NIDA: National Institute on Drug Abuse; NIH: National Institutes of Health; SD: standard deviation; SR: sustained release; THC: Δ9‐tetrahydrocannabinol; THC‐COOH: 11‐nor‐9‐carboxy‐Δ9‐tetrahydrocannabinol; TLFB: timeline follow‐back.