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

Heinzerling 2010.

Methods Double‐blind, randomised, placebo‐controlled clinical trial
Stastitical analysis: ITT
Participants n = 71 methamphetamine‐dependent outpatients (DSM‐IV‐TR)
Mean age: 38.4 years
Gender: 50 men
Race: African‐American: 4, Caucasian: 36, Other: 29
Employed: 54
History: days of methamphetamine use during past month: 9.3 days, lifetime methamphetamine use: 14.5 years
Route of methamphetamine use: 49 ip, 17 in, 4 iv, 1 oral
Interventions Two parallel groups:
1. Modafinil 400 mg qd (fixed posology), N = 34
2. Placebo, N = 37
+ CBT + CM (12 sessions)
Duration: 12 weeks
Multiple site (USA)
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‐II
Craving
Dropouts due to adverse events
Notes Author's affiliation: university
Co‐funding: public and private
Assessment of compliance: pill count and self‐report
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk An urn randomisation procedure used
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 62%). Missing outcome data balanced in numbers across intervention groups. Reasons for missing data partially described. No imputation methods used
Incomplete outcome data (attrition bias): Subjective measures 
 Subjective measures High risk High attrition in both study groups (globally 62%). Missing outcome data balanced in numbers across intervention groups. Reasons for missing data partially described. No imputation methods used
Selective reporting (reporting bias) Low risk More outcomes present in Clinicaltrials.gov than in the published report. But typical outcomes for those studies are reported
Other bias Low risk The study appears to be free of other sources of bias