Konstenius 2010.
Methods | Double‐blind, randomised, placebo‐controlled clinical trial. Relapse prevention trial Stastitical analysis: ITT |
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Participants | n = 24 amphetamine‐dependent outpatients (DSM‐IV) with ADHD, abstinent for a minimum of 2 weeks Mean age: 37.4 years Gender: 18 men Race: African‐American: NR, Caucasian: NR, Other: NR Employed: 5 History: days of methamphetamine use during past month: NR, lifetime methamphetamine use: 13.9 years Route of methamphetamine use: NR |
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Interventions | Two parallel groups: 1. Methylphenidate 18 to 72 mg qd (flexible posology), N = 12 2. Placebo, N = 12 + individual skills training program (12 sessions) Duration: 12 weeks Single site (Sweden) |
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Outcomes | Amphetamine use assessed with two‐times‐weekly UA Sustained abstinence (defined as at least 3 weeks of continuous abstinence) Retention in treatment Craving Depressive symptoms assessed by means of BDI‐II Anxiety symptoms assessed by BAI Dropouts due to adverse events |
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Notes | Author's affiliation: university Co‐funding: public and private Assessment of compliance: pill count |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Ranzomisation performed with Trombul software |
Allocation concealment (selection bias) | Low risk | Randomisation done by an independent pharmacist. Randomisation list was kept at the pharmacy until the end of the trial and was collected and opened thereafter |
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 | Unclear risk | Given that the studied intervention has powerful behavioural effects, it is likely that blinding was broken, which could have yielded to the provision of additional interventions, depending on the treatment the participant was receiving |
Blinding (detection bias): Subjective measures Subjective measures | Unclear risk | It is unclear whether blinding can be achieved when the study medication with powerful behavioural effects (methylphenidate) is compared with placebo |
Blinding (performance bias): Subjective measures | Unclear risk | Given that the studied intervention has powerful behavioural effects, it is likely that blinding was broken, which could have yielded to the provision of additional interventions, depending on the treatment the participant was receiving |
Incomplete outcome data (attrition bias): Objective measures except retention in treatment or dropout Objective outcomes | Unclear risk | Moderate attrition in both study groups (globally 29%). Missing outcome data not balanced in numbers across intervention groups. Reasons for missing data across groups not reported. Imputation by worst case scenario |
Incomplete outcome data (attrition bias): Subjective measures Subjective measures | Unclear risk | Moderate attrition in both study groups (globally 29%). Missing outcome data not balanced in numbers across intervention groups. Reasons for missing data across groups not reported. Imputation methods not reported |
Selective reporting (reporting bias) | Low risk | The report includes expected outcomes (current controlled trials) |
Other bias | Low risk | The study appears to be free of other sources of bias |