Mancino 2011.
| Methods | Double‐blind, randomised, placebo‐controlled clinical trial. Relapse prevention trial Stastitical analysis: not ITT, not PP |
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| Participants | n = 9 methamphetamine‐dependent outpatients (DSM‐IV) Mean age: 32.5 years Gender: 5 men Race: NR Employed: NR History: NR Route of methamphetamine use: NR |
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| Interventions | Two parallel groups: 1. Modafinil 400 mg qd, N = 6 2. Placebo, N = 3 + Psychotherapy not specified (weekly) Duration: 8 weeks Single site (USA) |
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| Outcomes | Amphetamine use assessed with three‐times‐weekly UA Withdrawal symptoms Retention in treatment Dropouts due to adverse events |
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| Notes | Author's affiliation: university Funding: NR Assessment of compliance: NR |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Urn randomisation |
| 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 | Unclear risk | Blinding theoretically can be achieved when a study medication with mild behavioural effects (modafinil) is compared with placebo. Nevertheless, information on whether medications used were identical in appearance is insufficient |
| Blinding (performance bias): Subjective measures | Unclear risk | Information is insufficient to permit judgement |
| Incomplete outcome data (attrition bias): Objective measures except retention in treatment or dropout Objective outcomes | High risk | High attrition (globally 78%). Reasons for missing data across groups not reported. Imputation methods not reported |
| Incomplete outcome data (attrition bias): Subjective measures Subjective measures | High risk | High attrition (globally 78%). Reasons for missing data across groups not reported. Imputation methods not reported |
| Selective reporting (reporting bias) | Low risk | The study protocol is available, and the study publication includes all outcomes. Information obtained from Clinicaltrials.gov |
| Other bias | High risk | Terminated because of lack of funding.The article is not published in a journal (no peer review process is involved for data included in the register) |