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

Anderson 2012.

Methods Double‐blind, randomised, placebo‐controlled clinical trial
Stastitical analysis: modified ITT
Participants n = 210 methamphetamine‐dependent outpatients (DSM‐IV), 20 with ADHD, 7 alcohol dependents
Mean age: 39 years
Gender: 124 men
Race: African‐American: 10, Caucasian: 148, Other: 52
Employed: not reported (NR)
History: < 18 days of methamphetamine use during last month: 84, > 18 days of methamphetamine use during last month: 126, lifetime methamphetamine use: NR
Route of methamphetamine use: NR
Interventions Three parallel groups:
1. Modafinil 200 mg qd (fixed posology), N = 72
2. Modafinil 400 mg qd (fixed posology), N = 70
2. Placebo, N = 68
+ CBT (36 sessions) + HIV counselling + motivational enhancement therapy (1 session)
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
Craving
Depressive symptoms assessed by means of HAM‐D
Overall functioning assessed by means of CGI
Dropouts due to adverse events
Notes Author's affiliation: university and other public institutions
Funding: public
Assessment of compliance: self‐report, pill count, modafinil and metabolite in urine
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Adapative urn randomisation used
Allocation concealment (selection bias) Low risk Central allocation. Using telephone. Pharmacy controlled
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. 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 all study groups (globally 53%). Missing outcome data balanced in numbers across intervention groups. Reasons for dropping out not reported. Analysis performed without imputation methods
Incomplete outcome data (attrition bias): Subjective measures 
 Subjective measures High risk High attrition in all study groups (globally 53%). Missing outcome data balanced in numbers across intervention groups. Reasons for dropping out not reported. Analysis performed without imputation methods
Selective reporting (reporting bias) Low risk The study protocol is available and the study report includes all outcomes
Other bias Low risk The study appears to be free of other sources of bias