Shin 2013.

Study characteristics
Methods	Study design: Randomized controlled trial Country: Russia Setting: Tuberculosis treatment clinic; Inpatient and outpatient hospital setting Eligibility criteria: Included were patients with tuberculosis (TB) who were registered for TB therapy and initiated treatment in one of the three study sites along with a diagnosis of alcohol abuse or dependence. Excluded were individuals under 18 years of age, patients who had liver function tests three times above the upper limit of normal range, patients who reported opioid use in the past month or returned positive urine screens for opioids, patients who were pregnant or breastfeeding, and patients with any other co‐occurring medical or psychiatric condition that would affect their ability to participate. Duration of follow‐up: 6‐months Informed consent: Not reported Ethical approvals: Partners Healthcare IRB and the State Research Center Virology and Biotechnology, Novosibirsk Region and the Siberian State Medical University of the Gederal Agency for Healthcare and Social Development IRB
Participants	Sample size: 196 (53 brief counseling, 47 naltrexone, 45 brief counseling + naltrexone, 51 treatment as usual) Description of the target population: Patients in treatment for tuberculosis Age: 40.9 years (SD=11.2) Sex: 17.9% female Race/Ethnicity: Not reported Marital status: 37.8% married/cohabitating Harmful alcohol use (baseline): AUDIT=18.3 (SD=7.6); 63% met criteria for alcohol dependence Co‐occurring disorders: Tuberculosis
Interventions	Type: Non‐pharmacologic; Pharmacologic; Non‐pharmacologic+pharmacologic Description: A) Brief counseling: an adapted version of NIAAAs Helping Patients with Alcohol Health Practitioner's Guide involving motivational interviewing embedded within treatment as usual; B) Naltrexone: Naltrexone along with brief adherence counseling embedded within treatment as usual; C) Combined brief counseling and naltrexone (study conditions A+B) Duration and frequency: Brief counseling involved six 10‐15 minute sessions delivered monthly. Naltrexone was prescribed as 50 mg/day for six months and six 5‐10 minute monthly adherence counseling sessions. The combined brief counseling and naltrexone condition involved six 15‐25 minute sessions focused on brief counseling and naltrexone adherence counseling. Delivery and provider: Tuberculosis physicians administered the brief counseling. Naltrexone was administered by TB clinic staff Comparison group: Treatment as usual included psychotherapy, disulfiram, and placebo implants administered by a narcologist/addiction specialist
Outcomes	Primary outcome(s): Abstinence Primary outcome measurement tool(s): Timeline Followback Secondary outcome(s): Heavy drinking days Secondary outcome measurement tool(s): Timeline Followback Time points: 6‐months
Notes	Study funding and conflicts of interest: National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse (R01AA016318, K24DA019855) Linked study records: clinicaltrials.gov NCT00675961
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Non‐blinded randomization assignment was generated by computer by the study team." Pg. 3
Allocation concealment (selection bias)	High risk	"Non‐blinded randomization assignment was generated by computer by the study team." Pg. 3
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Non‐blinded randomization assignment was generated by computer by the study team." Pg. 3
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcomes reported by participant not blind to intervention
Incomplete outcome data (attrition bias) All outcomes	Low risk	"We performed analysis based on "intention‐to‐treat". To address missing data on alcohol endpoints, log‐linear regression analyses were performed for multivariable analysis on datasets multiply imputed using Markov Chain Monte Carlo methods" Pg. 5
Selective reporting (reporting bias)	Unclear risk	Protocol not available