Injectable versus oral opioid maintenance treatment for heroin addicts currently failing to benefit from standard treatment: a three way Randomised Controlled Trial (RCT) of injectable heroin versus injectable methadone versus oral methadone maintenance

Reduction in illicit heroin, measured by urine drug screens taken on a weekly basis over 6 months.

Self-reported to researcher at baseline, 3 months and 6 months (in or out of treatment):
1. Changes in illicit heroin use:
1.1. Number of days used illicit heroin in past 30 days
1.2. No days injected/smoked/snorted illicit heroin in past 30 days
1.3. Average cost of illicit heroin on days used
1.4. Frequency of use in past month, as measured by the Drug Use Section of Opiate Treatment Index (OTI Q score)
2. Changes in other illicit opiate drug use (non-prescribed):
2.1. Injectable opioid pharmaceuticals (methadone, heroin)
2.1.1. Days used in past 30 days
2.1.2. Average cost
2.1.3. Estimate quantity on average day of use
2.2. Oral methadone/morphine:
2.2.1. Days used in past 30 days
2.2.2. Average cost
2.2.3. Estimate quantity on average day of use
2.3. Codeine/codeine like preparations:
2.3.1. Days used in past 30 days
2.3.2. Average cost
2.3.3. Estimate quantity on average day of use
3. Changes in illicit cocaine use:
3.1. Number of days used crack/cocaine in past 30 days
3.2. No days injected/smoked/snorted in past 30 days
3.3. Average cost of cocaine on days used
4. Other illicit drug use and alcohol - benzodiazepines, alcohol, cannabis:
4.1. No days used past 30 days
4.2. Average quantities consumed (estimated as diazepam mg equivalents; units alcohol; grams cannabis)
4.3. Average cost of each drug used on average day
5. Changes in high-risk injecting practices:
5.1. Participation in risk practices for blood borne virus transmission in preceding month using the Injecting Risk Questionnaire, with responses pegged according to number of times occurred in the past month
5.2. Assessment of injecting practices using self-report scale developed for the trial
6. Changes in general health status:
6.1. 36-item Short Form health survey (SF-36)
6.2. Euro-QoL instrument (EQ-5D)
7. Changes in psychosocial functioning:
7.1. 36-item Short Form health survey (SF-36)
7.2. Euro-QoL instrument (EQ-5D)
7.3. Psychosocial Adjustment Section of the OTI
8. Changes in criminality: self-report using adapted OTI Crime Section of MAP
9. Use of other health and social services: health, social and voluntary sector services used, days off work due to illness, criminal justice sector contacts - adapted REDUCE questionnaire for cost effectiveness analysis
10. Measures of patient expectation of and satisfaction with treatment
10.1. Treatment Perceptions Questionnaire
10.2. Drug Use, Expectations and Satisfaction Questionnaire to measure benefits and problems with using street heroin (developed for the trial) and expectations and satisfaction of treatment received whilst on trial (developed for trial)

In addition, we are monitoring injecting practices and complications, any post dosing side effects and serious and non-serious adverse event data and collecting data on retention.