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. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Kumar 2020.

Study characteristics
Methods Study design: randomized controlled cross‐over trial
Country: India
Setting: 0utpatient alcohol treatment
Eligibility criteria: individuals with alcohol dependence seeking outpatient treatment and reporting no other substance use
Duration of follow‐up: 6 months
Informed consent: all participants provided written informed consent
Ethical approvals: ethical review obtained. Institution not specified.
Participants Sample size: 90 (30 naltrexone, 30 acamprosate, 30 baclofen)
Description of the target population: Males in outpatient alcohol treatment
Age: not reported
Sex: 100% male
Race/Ethnicity: not reported
Marital status: >85%
Harmful alcohol use (baseline): mean duration of alcohol intake was 18.58 years (SD = 10.62) in baclofen group, 15.43 years (SD = 8.76) in acamprosate group, and 15.75 years (SD = 10 years) in naltrexone group.
Co‐occurring disorders: not described
Interventions Type: pharmacologic
Description (Group 1): Baclofen
Duration and frequency Group 1): started with 20 mg/day and increased to an average of 38.11 mg/day 
Description (Group 2): Acamprosate
Duration and frequency Group 2): started with 333 mg/day and increased to an average of 1021.2 mg/day
Description (Group 3): Naltrexone
Duration and frequency Group 3): started with 25 mg/day and increased to 50 mg/day
Delivery and provider: not described
Outcomes Primary outcome(s): relapse
Primary outcome measurement tool(s): Obsessive Compulsive Drinking Scale
Secondary outcome(s): risk of relapse
Secondary outcome measurement tool(s): Advance Warning of Relapse (AWARE) Questionnaire
Time points: 6 months
Notes Study funding and conflicts of interest: not reported
Linked study records: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization of the participants was done using a computerized random table." Pg. 2
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Our study was not blinded" Pg. 6
Blinding of outcome assessment (detection bias)
All outcomes High risk "Our study was not blinded" Pg. 6
Incomplete outcome data (attrition bias)
All outcomes High risk High dropout not equal across conditions (Table 5)
Selective reporting (reporting bias) Unclear risk Not described