Montoya 1994.
| Methods | Randomised placebo‐controlled trial | |
| Participants | Participants: 72 randomly assigned; 62 included in the analysis; mean age 33.2 years; 79% male; 68% black. Use of cocaine: at least 14 g of self reported cocaine use in the prior 3 months Route of administration: not reported Inclusion criteria: diagnosis: cocaine dependence (DSM‐lll‐R) Exclusion criteria: concurrent dependence on other drugs, concurrent institutional residence, illiteracy, history of seizure disorders, glaucoma, renal failure, asthma, bone marrow suppression, liver disease, lupus, other severe or uncontrolled psychiatric or medical disorders |
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| Interventions | (1) carbamazepine (28 participants): starting dose 200 mg up to 800 mg then gradually reduced by up to 200 mg;
(2) placebo (34 participants)
Setting: outpatient Follow‐up: 8 weeks Country of origin: USA |
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| Outcomes | Use of cocaine; Craving | |
| Notes | Study supported through NIH‐NIDA intramural research funds 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; no further information provided |
| Blinding of participants and personnel (performance bias) subjective outcomes | Unclear risk | Study declared as double‐blind; no further information provided |
| 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 | 10 participants (13.8%) started treatment but discontinued participation before completing 1 week of treatment. Not reported from which group they dropped out |
| 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 |