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
| ISRCTN | ISRCTN01338071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01338071 |
| Secondary identifying numbers | KCL/SLaM-CT2004-3 |
- Submission date
- 14/09/2007
- Registration date
- 27/09/2007
- Last edited
- 26/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof John Strang
Scientific
Scientific
National Addiction Centre
Addiction Sciences Building
4 Windsor Walk
Denmark Hill
London
SE5 8AF
United Kingdom
Study information
| Study design | Multi-site open-label randomised controlled trial to compare the safety, efficacy and cost-effectiveness of prescribing injectable opiates versus optimised oral methadone |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RIOTT (Randomised Injectable Opioid Treatment Trial) |
| 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 |
| Ethics approval(s) | 1. Institute of Psychiatry Ethics Committee for single-site study, 26/02/2004, ref: 291/03 2. London MREC for multi-site study, 03/06/2006, ref: 06/MREC02/22 |
| Condition | Opiate dependence/addiction |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Heroin, methadone |
| Primary outcome measure | Reduction in illicit heroin, measured by urine drug screens taken on a weekly basis over 6 months. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2004 |
| Overall study end date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 150 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/07/2004 |
| Recruitment end date | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Addiction Centre
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
South London and Maudsley NHS Foundation Trust and Kings College London (UK)
Hospital/treatment centre
Hospital/treatment centre
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
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Charity
Action on Addiction (UK) - Big Lottery Fund (research part of trial) (ref: PR/1/010256258)
No information available
National Treatment Agency (UK) - clinical part of trial (ref: 2007/08)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/05/2010 | Yes | No | |
| Results article | secondary outcome results | 01/03/2015 | Yes | No |
