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. 2013 Sep 2;2013(9):CD009695. doi: 10.1002/14651858.CD009695.pub2

Konstenius 2010.

Methods Double‐blind, randomised, placebo‐controlled clinical trial. Relapse prevention trial
Stastitical analysis: ITT
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
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)
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
Notes Author's affiliation: university
Co‐funding: public and private
Assessment of compliance: pill count
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