Table 2 Outcome measures

Illicit heroin use

• Self-reported data at 3 and 6 month interviews (including number of days used, routes of administration, average amount/cost, and frequency of use in past month as measured by the Opiate Treatment Index (OTI) Q score [43]; self-reported overdoses.

• Random weekly UDS result, testing for papaverine metabolites.

Other drug use

• Self-reported data at 3 and 6 month interviews regarding use of other opioids, alcohol, benzodiazepines, cannabis, cocaine. Measures include number days used, average cost/amount used.

• Random weekly UDS result

High-risk injecting practices

• Self-report data at 3 and 6 month interviews regarding participation in risk practices for blood borne virus transmission in preceding month using modified Injecting Risk Questionnaire [44]

• Self-report data regarding injecting practices in past month (including sites, routes, adverse events, complications) and clinical examination of injecting sites (monthly medical reviews)

General health status and psychosocial functioning

• Self-report data using SF-36 [45], EQ-5D [46, 47] and OTI Psychosocial Adjustment Section collected at 3 and 6 month interview

• Hospital Anxiety Depression Scale [48] completed at monthly medical review.

Changes in criminality

• Self – report data using modified Crime Section of Maudsley Addiction Profile [49] and OTI collected at 3 and 6 month interview

Measures of patient expectation and satisfaction

• Treatment Perceptions Questionnaire [50]

• Drug Use Expectations and User Nominated Outcome Instrument structured and semi-structured interviews examining patient perceptions of positives and negatives of using illicit heroin, and key outcomes/goals of treatment, as identified by service users (developed for the trial). Interviews conducted with service-user researcher at baseline, 3 and 6 months

• Semi-structured interviews with service-user researcher examining patient perspectives of the relative advantages and disadvantages of each of the three treatment approaches.