Halikas 1997 arm b.
| Methods | Randomised placebo‐controlled trial | |
| Participants | Participants: 183, cocaine dependents (DSM‐III‐R); mean age 32.5 years; 71% male; 66.1% white; participants had at least an eighth grade education Reporting cocaine use: 100% Route of administration not reported Inclusion criteria: at least 18 years old and eighth grade education, met DSM‐III‐R criteria for cocaine dependence, reported cocaine use for at least 10 of the previous 25 days Exclusion criteria: suicidal ideation, clinically unstable clinical condition, narrow angle glaucoma, seizure disorder, head trauma, blood dyscrasia, heart block, organic brain syndrome, bipolar affective disorder, schizoaffective illness, lactating or pregnant women, patients taking any psychotropic medications |
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| Interventions | (1) carbamazepine 800 mg (n = 58) (2) placebo (n = 63) Range of psychosocial interventions was offered to participants including group educational, cognitive, behavioural and supportive approaches Setting: outpatient Duration: 12 weeks Country of origin: USA | |
| Outcomes | Dropout; Use of cocaine; Craving; Side effect; Compliance | |
| Notes | Source of funding and conflict of interest: not reported; placebo tablets were provided by Ciba Geigy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "subjects were assigned to one of the three groups by means of randomized block design" |
| 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: "carbamazepine tablets were used; identical placebo tablets were provided by Ciba Geigy; double blind medications were packaged by the unblinded pharmacist into ten days blister packs" |
| Blinding of participants and personnel (performance bias) subjective outcomes | Low risk | Study declared as double‐blind Quote: "carbamazepine tablets were used; identical placebo tablets were provided by Ciba Geigy; double blind medications were packaged by the unblinded pharmacist into ten days blister packs" |
| 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 | High risk | 18% of participants failed to return at visit 1: 11 from the placebo group, 9 from the 400‐mg condition, 13 from the 800‐mg condition Evaluable participants: 150 out of 183 randomly assigned |
| 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 |