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| 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 |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN01338071 |
| Date ISRCTN assigned | 27/09/2007 |
| Local reference number(s) | KCL/SLaM-CT2004-3 |
| Public title | 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 |
| Scientific title | |
| Acronym | RIOTT (Randomised Injectable Opioid Treatment Trial) |
| Disease/condition/study domain | Opiate dependence/addiction |
| Study hypothesis | The research objective of the trial is to examine the safety, efficacy and cost effectiveness of treatment with injectable methadone or injectable heroin compared to optimised oral methadone treatment, for patients not responding to their current oral maintenance treatment episode. Hypotheses: 1. A selected group of patients (not responding to usual oral methadone treatment) receiving injectable heroin treatment or injectable methadone treatment, will make greater reductions in their illicit heroin use, other drug use and criminal activity and greater improvements in their health and social functioning, than if provided with optimised oral methadone treatment 2. Providing injectable heroin or injectable methadone to a selected group of patients (not responding to usual oral methadone treatment) results in a greater economic benefit per extra unit of resource invested in the treatment, than only offering optimised oral methadone |
| Design/methodology | A multi-site, open-label, randomised controlled trial to compare the safety, efficacy and cost effectiveness of prescribing injectable opiates versus optimised oral methadone. |
| Research ethics review | Ethics approval received from: 1. Institute of Psychiatry Ethics Committee for single-site study, granted 26th February 2004 (ref: 291/03) 2. London MREC for multi-site study, granted 3rd June 2006 (ref: 06/MREC02/22) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | The selection criteria targets heroin users with a long-standing history of injecting heroin use who continue to inject heroin frequently whilst in their current episode of methadone treatment. Selection criteria include: 1. History of injecting heroin use sufficient to meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria 2. Aged between 18 and 65 years at recruitment to study 3. In continuous methadone treatment for at least 6 months this episode 4. Regular injecting heroin use |
| Participants - exclusion criteria | 1. No active significant medical (e.g., hepatic failure) or psychiatric condition (active psychosis, severe affective state) as determined by study medical officer 2. Not alcohol dependent or abusing benzodiazepines according to DSM-IV revised criteria 3. Not pregnant, breast feeding, or planning to become pregnant during the study period 4. Able and willing to participate in the study procedures (e.g., no impending prison sentence) and provide informed consent |
| Patient information material | |
| Anticipated start date | 01/07/2004 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | 150 |
| Interventions | Patients randomised to receive optimised oral methadone treatment will receive methadone treatment under enhanced conditions. The intervention will include high methadone doses (at least 80 mg), supervised dispensing of medications contingent upon levels of unsanctioned drug use (daily supervised dosing initially), and patients will be expected to attend for regular key worker and medical appointments. Methadone is a semi-synthetic opioid used in the treatment of opioid drug dependence to prevent opioid withdrawal syndrome by substituting for heroin. The injectable methadone group will receive treatment with once-daily injectable (intraveous [IV]/intramuscular [IM]) methadone ampoules. There will be full supervision of all injected doses. Patients will be expected to attend for regular key worker and medical appointments. Patients will be able to supplement their injectable methadone dose with prescribed oral methadone doses. Methadone Hydrochloride B.P. for injection is a colourless, preservative and oxidant free solution in clear glass ampoules. Those receiving injectable heroin will receive treatment with injectable (IV/IM) heroin ampoules, administered under supervision up to twice a day. Patients will be expected to attend for regular key worker and medical appointments. Patients will be able to supplement their injectable heroin dose with prescribed oral methadone doses. Diacetylmorphine hydrochloride (Diamorphine hydrochloride, heroin hydrochloride, heroin) is a opioid used in the treatment of opioid drug dependence. All injections are supervised in the clinic. All those receiving injectable treatment or optimised oral methadone treatment will receive named keyworker and frequent reviews and ancillary services. The total duration of treatment and follow-up is 6 months. |
| Primary outcome measure(s) | Reduction in illicit heroin, measured by urine drug screens taken on a weekly basis over 6 months. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | 1. Action on Addiction (UK) - Big Lottery Fund (research part of trial) (ref: PR/1/010256258) 2. National Treatment Agency (UK) - clinical part of trial (ref: 2007/08) |
| Sponsor name | South London and Maudsley NHS Foundation Trust and Kings College London (UK) |
| Sponsor details | c/o Dr Gill Dale Director of Research Quality Joint R&D Office of South London and Maudsley NHS Foundation Trust and Institute of Psychiatry P005 Institute of Psychiatry De Crespigny Park London United Kingdom SE5 8AF |
| Sponsor website | http://www.kcl.ac.uk/ |
| Contact name | Prof John Strang |
| Contact details | National Addiction Centre Addiction Sciences Building 4 Windsor Walk Denmark Hill London United Kingdom SE5 8AF |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN01338071 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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