Stein 2002.

Methods	Study design: RCT. Recruitment modality of participants: study was advertised at 3 NEP sites using posters. NEP volunteers offered all clients referral cards. NEP clients called a study telephone to be screened by a research assistant at a separate research site in hospital. During the initial study visit, all NEP clients presented their study cards (received at NEP). Conducted between February 1998 ‐ October 1999.
Participants	Number of participants: 187 Gender: 119 male (63.6%) Mean age: 36.2 years Condition: problem alcohol use, i.e. AUDIT‐positive (> 8) active IDUs. "Current alcohol abuse or dependence diagnosis was ascertained using the SCID interview. 159 (85.0%) met DSM‐IV criteria for current alcohol abuse (80%) or dependence (70%)". Participants were eligible if they were not receiving formal drug or alcohol treatment, with the exception of self‐help groups. Other relevant information Baseline sample characteristics: mean number of years of education: 11.5 years; ethnicity: 162 (86.6%) Caucasian; most frequently injected drug: heroin for 141 (75.4%) participants, cocaine for 15 (8.0%), heroin and cocaine for 31 (16.6%); 120 (64.1%) participants visited the NEP at least once a month; mean AUDIT score at screening was 22.2; 159 (85.0%) met DSM‐IV criteria for current alcohol abuse or dependence (80% for abuse, 70% for dependence); mean ± SD number of drinking days in the past 30 days prior to baseline assessment: 12.0 ± 10.3; 71.4% of quantities on all drinking days exceeded conventional criteria defining heavy alcohol consumption (5+ drinks for men and 3+ drinks for women); mean ± SD drinks per drinking days 7.3 ± 5.8.
Interventions	(1) MI group: focus on alcohol use and HIV risk‐taking (n = 95) Goals: to assess the degree to which the participant engages in hazardous drinking; to identify relationships between alcohol consumption and alcohol‐related negative consequences including HIV risk behaviour; to identify goals for behaviour change and any barriers to change. Included a written change plan, designed to reduce the link between alcohol consumption and hazardous behaviours that may lead to negative consequences of drinking, including HIV risk behaviour Interventionist trained by studying the manual and watching MI tapes from Project MATCH Standard delivery of the MI protocol Adherence monitoring by: an MI checklist completed by the therapist after each session and audiotapes of sessions were randomly reviewed by a supervisor trained in MI (2) Control group: assessment‐only, approximately 3 hours (n = 92) Duration of the intervention: 2 therapist sessions, 1 month apart; 1st session: 60 minutes, 2nd session: 30 to 45 minutes. Duration of follow‐up: 1 and 6 months Country of origin, setting: NEP clients, study site: Rhode Island Hospital in Providence, USA.
Outcomes	Alcohol use as number of days in the past 30 days with alcohol use at 1 month Alcohol use as number of days in the past 30 days with alcohol use at 6 months Alcohol use as 25% reduction of drinking days in the past 30 days Alcohol use as 50% reduction of drinking days in the past 30 days Alcohol use as 75% reduction of drinking days in the past 30 days Alcohol use as 1 or more drinking days' reduction in the past 30 days Alcohol use as 7 or more drinking days' reduction in the past 30 days Number of days in the past 30 days with IRRB ‐ defined as answer to a question: "Have you used needles etc. after someone else?" (reported only for a subset of 109 participants in the Stein 2002b paper). Retention ‐ end of treatment
Notes	Control and MI subjects received identical research assessments at baseline, 1 and 6 months: at baseline and 1 month later, both MI and control group received a list of referrals for substance abuse and medical treatment; participants in the control group spent approximately 3 total hours (assessment time) with research staff, "the assessment included sections on demographics, drug and alcohol use, drug and alcohol treatment, health‐related quality of life, attitudes and experiences with alcohol and HIV risk behavior"; the assessment control group also experienced meaningful reduction in alcohol use; 6‐month follow up: 11 subjects were interviewed in prison and 6 were interviewed by telephone; total reimbursement: $90 with $20 given at baseline, $30 at the 1‐month interview and $40 at the final interview; 65 (34.8%) participants reported 4 or fewer drinking days at baseline: their maximum possible decrease in drinking days at follow‐up is 4 or less (i.e. floor and ceiling effects); change in heroin use was not associated with change in alcohol use; the association between change in IRRB days and change in alcohol use days was not statistically significant. The paper reporting IRRB outcomes (Stein 2002b) was included in another Cochrane Review (Meader 2010); therefore, it was not considered for this review. The study was funded by National Institutes of Health; information on conflicts of interest was not provided.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not enough information provided: "Following the baseline interview subjects were assigned to treatment conditions using a randomisation schedule created with permuted blocks of eight assignments." "After randomisation, the research interventionist saw participants assigned to MI...".
Allocation concealment (selection bias)	Unclear risk	Not stated how the randomisation schedule was prepared: "This method ensured that the treatment groups were balanced in number to within four patients throughout the trial. The data manager prepared the randomisation schedule before the first patient enrolled".
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	"At each follow‐up assessment, research assistants were blinded to the treatment condition of the subject; the interventionist did not perform research assessments".
Incomplete outcome data (attrition bias) End of Study outcomes	Unclear risk	Not available. The study did not assess outcomes at the time of the study end.
Incomplete outcome data (attrition bias) Follow up	Low risk	"We conducted an intent‐to‐treat analysis using a conservative 'worst case scenario' strategy in which observations with missing follow‐up data were assigned the maximum value of 30 drinking days, a data imputation approach which tends to minimize observed reductions in mean drinking days across time. To ensure that our substantive results were not sensitive to missing observations (there were no condition differences in missing data) we replicated our analyses using observations with complete data (n = 181), and using other imputation strategies (e.g. mean substitution, regression estimation and 'best case scenario'). All imputation strategies resulted in substantively consistent findings. To evaluate the adequacy of random assignment, we used t‐ and x2‐tests to compare treatment groups with respect to background characteristics and baseline measures of drinking behaviours and alcohol problems". Number of dropouts and reasons: There were no study withdrawals: 93 of 95 in the MI group received both MI sessions: 2 people missed their second session. 6‐month follow‐up data were available for 96.8% (n = 181) of the 187 randomly assigned subjects. 3 subjects in each treatment arm were lost to follow‐up at 6 months.
Selective reporting (reporting bias)	Low risk

ASI: Addiction Severity Index; ASSIST: Alcohol, Smoking and Substance Involvement Screening Test; ASP: antisocial personality disorder; BAL: blood alcohol level; BI: brief intervention; CBCST: cognitive‐behavioural coping skills training; CBT: cognitive behavioural therapy; CM: clinical management; DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders, Third Edition ‐ Revised; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; HCV: hepatitis C virus; HIV: human immunodeficiency virus; HHP: hepatitis health promotion; ICD‐10: International Classification of Diseases ‐ Tenth Revision; IDU: injection drug use; ITT: intention to treat; IRRB: injection‐related HIV risk behaviour; MI: motivational intervention; MSW: master in social work; NEP: needle exchange programme; PhD: doctor of philosophy; PWID: people who use illicit drugs; RCT: randomised controlled trial; SD: standard deviation; TAU: treatment as usual; TLFB: timeline follow‐back; TSF: twelve‐step facilitation programme; UCG: usual care group; WHO: World Health Organization.