| Methods |
Design: three group parallel trial
Purpose: study the effect of naltrexone for alcohol dependence |
| Participants |
Patients: outpatients with alcohol dependence
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo: NS (12 weeks)
Untreated: no placebo or naltrexone
Experimental: naltrexone
(Co‐intervention: various individual or group programs) |
| Outcomes |
Alcohol consumption (time line follow‐back: average drinks per day, percent days drinking, drinks per drinking days, heavy drinking days)
Percentage with at least one heavy drinking episode
Craving (obsessive compulsive drinking scale)
Various explorative analyses |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
urn randomisation |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 59 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
