Kampman 2013.
Methods | Randomised placebo‐controlled trial | |
Participants | Participants: 170 DSM‐IV cocaine dependent; mean age 44 years; male 79%. African American 83%, Caucasian 17% Education: 12.7 years (mean) Reporting cocaine use: 100% Route of cocaine used: smoked 78%, intranasal 21%: years of cocaine use: 14 (mean) Inclusion criteria: In the 30 days before study entry, participants used no less than $200‐worth of cocaine and met the following drinking criteria as measured by the Timeline Followback (TLFB; Sobelland Sobell, 1995): (1) drank within 30 days of intake day, (2) reported a minimum of 48 standard alcoholic drinks (avg 12 drinks/wk) for women and 60 standard drinks (15 drinks/wk) for men in a consecutive 30‐day period over the 90‐day period before starting intake, and (3) had 2 or more days of heavy drinking (defined as 5 or more drinks/d in males and 4 or more drinks/d in females) in this same pretreatment period Exclusion criteria: Patients with current dependence (DSM‐IV criteria) on any additional drug except nicotine and cannabis were excluded. Psychiatric exclusion criteria included psychosis, dementia and use of other psychotropic medications. Medical exclusion criteria included unstable medical illness, impaired renal function and a history of hypersensitivity to topiramate. Patients with a history of kidney stones and those taking carbonic anhydrase inhibitors or any other antiepileptic drugs were excluded from the study |
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Interventions | (1) topiramate titrated to 300 mg daily; participants 83; (2) placebo, participants 87 In addition to medication or placebo, participants received weekly individual cognitive‐behavioural relapse prevention therapy utilising a Cognitive‐Behavioural Coping Skills Therapy (CBT) manual Setting: outpatient Follow‐up: 13 weeks Country of origin: USA |
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Outcomes | Alcohol and cocaine use; Treatment retention; Severity of addiction‐related problems measured by the Addiction Severity Index (ASI); Minnesota Cocaine Craving Scale (MCCS) for cocaine craving intensity (MCCS‐I), cocaine craving frequency (MCCS‐F) and cocaine craving duration (MCCS‐D); Adverse events; Compliance | |
Notes | The National Institute on Drug Abuse (NIDA) provided funding for this trial through the following grants: P60‐DA‐05186‐17, P50DA012756 and T32 MH065218. NIDA had no further role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper Conflict of interest: All study authors declare they have no conflict of interest |
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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 double‐blind Quote: "The Investigational Drug Service of the University of Pennsylvania prepared study medication by over encapsulating topiramate tablets and preparing identical appearing placebo capsules" |
Blinding of participants and personnel (performance bias) subjective outcomes | Low risk | Study declared double‐blind Quote: "The Investigational Drug Service of the University of Pennsylvania prepared study medication by over encapsulating topiramate tablets and preparing identical appearing placebo capsules" |
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 but 1 expected outcomes, including those that were prespecified in the Methods section. Results for cocaine craving not reported. Study authors only stated that they noted no differences |