Berger 2005 arm a.
| Methods | Randomised placebo‐controlled trial | |
| Participants | Participants: 60, mean age 39.1 years; male 70%; African American 92%, Caucasian 8%; married 23%, separated/divorced 31%, never married 45% Education: median 12.3 years Employment: full time 55%, part time 28%; student 8%, unemployed 8% Reporting cocaine use: 100% Use of cocaine in the past 30 days: 18.5 days Route of administration: smoked 93%, intravenous 5%, intranasal 2% Inclusion criteria: fulfilling DSM‐IV criteria for cocaine dependence Exclusion criteria: criteria utilised in CRES trial |
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| Interventions | (1) lamotrigine 150 mg/d tapered, 15 participants; (2) placebo, 15 participants
For all adjunct cognitive‐behavioural therapy
Outpatient Duration: 10 weeks (2 of screening and 8 of intervention) Country of origin: USA |
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| Outcomes | Dropout; Use of cocaine; Severity of dependence; Craving; Side effect; Depression; Anxiety; Compliance | |
| Notes | Funded by the National Institute on Drug Abuse (NIDA) under Interagency Agreement Y 01 DA
50038–00 Urinalyses were funded by NIDA contract N01DA‐7–8074 Conflict of interested: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were assigned randomly to a medication or placebo arm of the study at the end of the baseline period" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Participants were assigned randomly to a medication or placebo arm of the study at the end of the baseline period" |
| Blinding of participants and personnel (performance bias) objective outcomes | Low risk | Quote: "The medications used in this study were not blinded in terms of appearance; thus, the unblinded study pharmacist handled all medication manipulations, including weekly dispensing and pill counts" Comment: objective outcomes unlikely to be biased by lack of blinding |
| Blinding of participants and personnel (performance bias) subjective outcomes | High risk | Quote: "The medications used in this study were not blinded in terms of appearance; thus, the unblinded study pharmacist handled all medication manipulations, including weekly dispensing and pill counts" |
| 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 | Dropout: lamotrigine 20%; placebo 7%; P value ns Quote: "each participant’s end‐point is the last observation obtained regardless of the time‐point at which it was obtained. Thus, for a participant who dropped out after visit 1, his or her end‐point would be visit 1 and, thus, equivalent to the baseline observation. For a participant who completed the trial, his or her end‐point would be from study week 8" |
| Selective reporting (reporting bias) | Low risk | Published reports include all expected outcomes, including those that were prespecified |