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 |