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 |