Crosby 1996.
Methods | Randomised placebo‐controlled trial | |
Participants | Participants: 44; mean age 34 years; male 79.5%; African American 57%; married 34% Education: less than high school 14%, high school 70%, college 15%: current employed 59% Reporting cocaine use: 100% Route of cocaine ingestion: intranasal 4.5%, smoking 93%, intravenous 2%; cocaine use in the past 30 days mean 11.7 days; number of previous treatments mean 1.5; lifetime cocaine abuse mean 90 months; alcohol use to intoxication in the past 30 days: 3.0 days Inclusion criteria: 18 years old, fulfilling DSM‐IV criteria for current cocaine abuse/dependence Exclusion criteria: current clinical unstable medical illness or history of seizure disorder, history of head trauma resulting in brain injury or history of heart block or other cardiac disorder; lifetime psychiatric diagnosis of mental retardation precluding the ability to read, understand and complete written tests; organic brain syndrome with cognitive impairment; schizophrenia, bipolar affective disorder, schizoaffective disorder, suicidal risk, pregnancy, use of any psychiatric agent or mood‐altering medication in the previous 6 weeks |
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Interventions | (1) phenytoin 100 mg/d, 20 participants; (2) placebo, 24 participants
Outpatient Duration: 12 weeks Country of origin: USA |
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Outcomes | Dropout; Use of cocaine; Craving; Side effect; Compliance | |
Notes | Source of funding and conflict of interest: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information not reported |
Allocation concealment (selection bias) | Unclear risk | Information not reported |
Blinding of participants and personnel (performance bias) objective outcomes | Low risk | Study declared as double‐blind Quote: "subjects were seen weekly by a trained psychotherapist blinded to treatment condition" |
Blinding of participants and personnel (performance bias) subjective outcomes | Low risk | Study declared as double‐blind Quote: "subjects were seen weekly by a trained psychotherapist blinded to treatment condition" |
Blinding of outcome assessment (detection bias) objective outcomes | Low risk | Study declared as double‐blind Quote: "all clinical rating were made by trained chemical dependency counsellors who were blinded to treatment condition" |
Blinding of outcome assessment (detection bias) subjective outcomes | Low risk | Study declared as double‐blind Quote: "all clinical rating were made by trained chemical dependency counsellors who were blinded to treatment condition" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "16 subjects, 9 receiving phenytoin (31%) and 7 receiving placebo (23%) failed to return to visit 1 and were eliminated from the analysis. 12 subjects completed the twelve weeks protocol, 6 receiving phenytoin (20.7%) and 6 (19.4%) receiving placebo" |
Selective reporting (reporting bias) | Low risk | Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified in the Methods section |