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. 2011 May 11;2011(5):CD008063. doi: 10.1002/14651858.CD008063.pub2

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)
Outcomes Physiological primary: Blood GGT, CDT, urine drug screen.
Non‐physiological primary: Number relapsed, drinks per drinking day, percent abstinent.
Secondary: None.
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.