Anton 2005.
Methods | RCT. | |
Participants | 160 outpatient alcoholics from the USA. | |
Interventions | 1. naltrexone + MET (n= 41) 2. placebo + MET (n= 39) 3. naltrexone + CBT (n= 39) 4. placebo + CBT (n= 41) |
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Outcomes |
Physiological primary: Blood GGT, CDT, urine drug screen. Non‐physiological primary: Number relapsed, drinks per drinking day, percent abstinent. Secondary: None. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Subjects were randomly assigned to 1 of 4 treatment conditions". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment. |
Blinding (performance bias and detection bias) Patients and providers | Low risk | No blinding, but most outcomes were physiological and also used to validate self‐reports, and not likely to be influenced by lack of blinding. |
Blinding (performance bias and detection bias) Assessors | Low risk | Insufficient information to know whether assessors were blinded. But most outcomes were physiological and also used to validate self‐reports, and not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 15% attrition at 12 weeks post‐treatment. Balanced across conditions. Reasons addressed. ITT performed. "All outcome analyses were conducted under an intent‐to‐treat analysis plan on all subjects who had at least 1 postrandomization outcome measurement." |
Selective reporting (reporting bias) | Unclear risk | The published report included all expected outcomes based on the stated hypotheses. |
Other bias | Low risk | Used collateral and biological measurement to corroborate self‐reports of substance use. There were no differences between groups at baseline. No additional sources of bias appear to be present. |