Kampman 2004.
| Methods | Randomised placebo‐controlled trial | |
| Participants | Participants: 40; mean age 40 years; male 97.5%; African American 90%, Caucasian 10%; mean years of education 12 years; use of cocaine in the previous month: mean 7 days Reporting cocaine use: 100% Route of cocaine ingestion: intranasal 12.5%, smoked 87.5% Inclusion criteria: age 18 to 60 years, fulfilling DSM‐IV criteria for cocaine dependence Exclusion criteria: current dependence (DSM‐IV) on any additional drug except nicotine; psychosis, dementia, use of psychotropic medication; unstable medical illness, use of antiepileptic medication, history of nephrolithiasis, history of glaucoma, hypersensitivity to topiramate |
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| Interventions | (1) topiramate starting dose 25 mg/d increased to 200 mg/d then tapered, 20 participants; (2) placebo, 20 participants Outpatient Duration: 13 weeks Country of origin: USA |
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| Outcomes | Dropout; Use of cocaine; Severity of dependence; Craving; Side effect; Compliance | |
| Notes | Study funded by NIDA grant DA12756 Conflict of interest: not reported |
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| 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: "Study medication was prepared by the Research Pharmacist at the Hospital of the University of Pennsylvania by over‐encapsulating topiramate 25 and 100 mg tablets, purchased from a commercial pharmacy, and producing identical‐appearing lactose‐containing placebo capsules, Study medication was placed in blister packs with each day’s dose clearly marked. Medications were dispensed by the study physician each week and the previous week’s blister pack was collected" |
| Blinding of participants and personnel (performance bias) subjective outcomes | Low risk | Study declared as double‐blind Quote: "Study medication was prepared by the Research Pharmacist at the Hospital of the University of Pennsylvania by over‐encapsulating topiramate 25 and 100 mg tablets, purchased from a commercial pharmacy, and producing identical‐appearing lactose‐containing placebo capsules, Study medication was placed in blister packs with each day’s dose clearly marked. Medications were dispensed by the study physician each week and the previous week’s blister pack was collected" |
| Blinding of outcome assessment (detection bias) objective outcomes | Low risk | Information not reported Comment: objective outcomes unlikely to be biased by lack of blinding |
| Blinding of outcome assessment (detection bias) subjective outcomes | Unclear risk | Information not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis performed on an intention‐to‐treat basis |
| 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 |