Elkashef 2008 a.
| Methods | Double‐blind, randomised, placebo‐controlled clinical trial Stastitical analysis: nearly ITT |
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| Participants | n = 151 methamphetamine‐dependent outpatients (DSM‐IV). 20 with ADHD Mean age: 36 years Gender: 101 men Race: African‐American: 4, Caucasian: 112, Other: 35 Employed: NR History: days of methamphetamine use during last month: NR, lifetime methamphetamine use: 10.2 years Route of methamphetamine use: 98 ip, 25 in, 28 iv, 0 oral, 0 rectal |
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| Interventions | Two parallel groups: 1. Bupropion 300 mg tid. (fixed posology), N = 79 2. Placebo, N = 72 + CBT (1 session per week) + CM + groupal CBT (3 sessions per week) Duration: 12 weeks Multiple site (USA) |
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| Outcomes | Amphetamine use assessed with one‐time‐weekly UA Sustained abstinence (defined as at least 3 weeks of continuous abstinence) Self‐reported amphetamine use Retention in treatment Craving assessed by means of BSCS Depressive symptoms assessed by means of HAM‐D Addiction Severity Index |
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| Notes | Author's affiliation: university and other public institutions Funding: public Assessment of compliance: weekly tablet count |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adaptive urn randomisation was used to balance groups |
| 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 (bupropion) 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 | Unclear risk | Moderate attrition in both study groups (globally 48%). Missing outcome data balanced in numbers across intervention groups but reasons not reported. Missing data have not been imputed |
| Incomplete outcome data (attrition bias): Subjective measures Subjective measures | Unclear risk | Moderate attrition in both study groups (globally 48%). Missing outcome data balanced in numbers across intervention groups but reasons not reported. Missing data have not been imputed |
| Selective reporting (reporting bias) | Unclear risk | Some reported outcomes are not included in Clinicaltrials.gov |
| Other bias | High risk | ADHD was not balanced between groups (8% bupropion vs 19% placebo) |