Shoptaw 2008.
| Methods | Double‐blind, randomised, placebo‐controlled clinical trial Stastitical analysis: ITT |
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| Participants | n = 73 methamphetamine‐dependent outpatients (DSM‐IV TR) Mean age: 34.6 years Gender: 47 men Race: African‐American: 2, Caucasian: 41, Other: 30 Employed: 57 History: days of methamphetamine use during past month: 15.7 days, lifetime methamphetamine use: 9.6 years Route of methamphetamine use: 47 ip, 16 in, 9 iv, 1 oral, 0 rectal |
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| Interventions | Two parallel groups: 1. Bupropion SR 150 mg bid (fixed posology), N = 36 2. Placebo, N = 37 + CBT + CM ( 12 sessions) Duration: 12 weeks Multisite trial (USA) |
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| Outcomes | Amphetamine use assessed with three‐times‐weekly UA Sustained abstinence (defined as at least 3 weeks of continuous abstinence) Retention in treatment Depressive symptoms assessed by means of BDI Dropouts due to adverse events |
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| Notes | Author's affiliation: university Funding: public Assessment of compliance: weekly pill counts, reports of medication taking |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding (detection bias): Objective measures Objective measures | Low risk | Outcome or outcome measurement was not likely to be influenced by lack of blinding |
| Blinding (performance bias): Objective measures | Low risk | Given that the studied intervention has mild behavioural effects, it is unlikely that blinding was broken |
| Blinding (detection bias): Subjective measures Subjective measures | Low risk | Study medication and matched placebo have identical appearance, and blinding can be achieved when the study medication with mild behavioural effects (modafinil) is compared with placebo |
| Blinding (performance bias): Subjective measures | Low risk | Given that the studied intervention has mild behavioural effects, it is unlikely that blinding was broken |
| Incomplete outcome data (attrition bias): Objective measures except retention in treatment or dropout Objective outcomes | High risk | High attrition in both study groups (globally 66%). Missing outcome data balanced in numbers across intervention groups, similar reasons for missing data across groups. No imputation methods used |
| Incomplete outcome data (attrition bias): Subjective measures Subjective measures | High risk | High attrition in both study groups (globally 66%). Missing outcome data balanced in numbers across intervention groups, similar reasons for missing data across groups. No imputation methods used |
| Selective reporting (reporting bias) | Unclear risk | Fewer outcomes present in Clinicaltrials.gov than in the published report |
| Other bias | Low risk | The study appears to be free of other sources of bias |