Kranzler 1995.

Methods	Randomised placebo‐controlled trial
Participants	Participants: 40, cocaine dependents (DSM‐III‐R); age range 18 to 45 years; 100% male; 32% black Reporting cocaine use: 100% Use of cocaine: at least 4 g of cocaine during the preceding month Route of administration: smoked 75%, intranasal 25% Inclusion criteria: men, aged 18 to 45 years, reading comprehension skills adequate for providing written informed consent and for completing study questionnaires, met DSM‐III‐R criteria for current cocaine dependence, having used at least 4 g of cocaine during the preceding month Exclusion criteria: met DSM‐III‐R criteria for current dependence on any drug other than cocaine and nicotine, major medical (hematological, neurological, renal, cardiovascular or hepatic) disorder, had an unstable psychiatric condition (e.g. schizophrenic, acutely suicidal). Recent use of prescription or over‐the‐counter psychoactive medications other than cocaine, a history of seizures (including drug‐related seizures) or a history of serious head injury (i.e. resulting in loss of consciousness for longer than 30 minutes), absence of a stable living situation
Interventions	(1) carbamazepine (20 participants): 200 mg/d up to 600 mg/d (2) placebo (20 participants) Setting: outpatient Follow‐up: 12 weeks of treatment; 3 months after treatment Country of origin: USA
Outcomes	Retention; Use of cocaine; Use of other substances; Side effect
Notes	Study supported by grants PSO‐DA04060 from the National Institute on Drug Abuse and K20‐ AA00143 (to Henry R. Kranzler) from the National Institute on Alcohol Abuse and Alcoholism. Carbamazepine and matching placebo were generously donated by Ciba‐Geigy Pharmaceuticals 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)	Low risk	Quote: "Subjects were randomly assigned to treatment condition by a research pharmacist, who also was not involved in the clinical care of the subjects"
Blinding of participants and personnel (performance bias) objective outcomes	Low risk	Study declared as double‐blind Quote: "Medication was contained in identical opaque capsules containing carbamazepine 100 mg or matching placebo"
Blinding of participants and personnel (performance bias) subjective outcomes	Low risk	Study declared as double‐blind Quote: "Medication was contained in identical opaque capsules containing carbamazepine 100 mg or matching placebo"
Blinding of outcome assessment (detection bias) objective outcomes	Low risk	Study declared as double‐blind Quote: "All assessments were conducted by a research evaluator who was blind to the treatment condition and had no other contact with the subjects. A psychiatrist monitored plasma levels of carbamazepine and clinical laboratory results to protect against adverse effects. This psychiatrist had no direct contact with subjects once they were randomized"
Blinding of outcome assessment (detection bias) subjective outcomes	Low risk	Study declared as double‐blind Quote: "All assessments were conducted by a research evaluator who was blind to the treatment condition and had no other contact with the subjects. A psychiatrist monitored plasma levels of carbamazepine and clinical laboratory results to protect against adverse effects. This psychiatrist had no direct contact with subjects once they were randomized"
Incomplete outcome data (attrition bias) All outcomes	High risk	Not reported how many participants' results were included. Use of cocaine and of other substances was computed
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