The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder
| ISRCTN | ISRCTN69313751 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69313751 |
| Secondary identifying numbers | ARC2_LHH_2013 |
- Submission date
- 13/05/2013
- Registration date
- 23/05/2013
- Last edited
- 08/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Illicit heroin (illicit drug) has a very high risk of addiction, the main symptom being compulsive drug use despite significant health and social harms. Currently, the majority of people presenting to specialist NHS community treatment clinics have established harmful illicit opioid addiction (drug addiction) but the addiction to cocaine adds considerable severity and this type of patient has a relatively poorer treatment outcome compared to primary heroin users. In the NHS, the standard treatment to heroin dependence is the prescription of a substitute (full or partial) μ-opioid agonist (a medicine) taken once daily along with general counselling support (TAU). About 60-70% retained in treatment for at least six months. However, not all patients derive a clinical benefit. Some respond initially, then resume heroin use during the treatment; a minority deteriorate progressively during the treatment. A Personalised Behavioural Intervention (PBI) has been developed which adapts and integrates techniques from evidence-based, approved psychological treatment for patients who have not responded to standard treatment. The aim is to enable these patients to refrain from heroin and cocaine use.
Who can participate?
Patients who attend Lorraine Hewitt House (LHH), an NHS treatment centre in London and who have received at least 6 weeks of treatment within the clinic service but are still using heroin or cocaine
What does the study involve?
The PBI combined with TAU is compared against TAU alone. Potential participants are selected from those who self-report of heroin use or cocaine use via an interview which is confirmed by an on-site urine test for the presence of these drugs. All participants are provided with written and verbal information about what is required during participation in the study. Those patients refusing to participate receive the standard treatment package at LHH. Participants are randomly allocated to one of two groups using an automated system. Thereafter, participants in the PBI group attend 12 weekly PBI sessions and TAU sessions (case management and general counselling) weekly or fortnightly. Participants in the TAU group only attend case management and general counselling support sessions on a weekly or fortnightly basis. All participants continue to receive treatment as clinically indicated with supervised consumption at community pharmacies. A variety of factors are measured at baseline and at the final follow-up. Further, some of the factors are measured at three points during the 12-week treatment period. In addition, participants are also given the option of participating in two further studies:
1. To provide a DNA sample for research into genetic factor links to treatment response
2. To participate in a longer term study to find out what happens to participants in the study over the next 5 years
They are asked to allow their personal details to be flagged on three public databases: National Drug Treatment Monitoring System (NDTMS), Police National Computer (PNC), NHS Registry of Births and Deaths (NHSCR).
What are the possible benefits and risks of participating?
There are no confirmed direct benefits to participants. There are no greater risks than would occur in the standard treatment program.
Where is the study run from?
Lorraine Hewitt House (LHH), an NHS treatment centre in London, UK
When is the study starting and how long is it expected to run for?
October 2012 to April 2018
Who is funding the study?
Action on Addiction (UK)
Who is the main contact
Prof. John Marsden
john.marsden@kcl.ac.uk
Contact information
Scientific
Addictions Department
Institute of Psychiatry
Box 48, Addiction Sciences Building
De Crespigny Park
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-1307-2498 |
|---|---|
| john.marsden@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder: a randomised controlled trial |
| Study acronym | ARC |
| Study hypothesis | Is there any difference in the clinical and cost effectiveness of a 12-week personalised behavioural intervention (PBI) and treatment-as-usual (TAU) compared to TAU alone at achieving heroin and cocaine abstinence and improved health-related quality of life economic outcomes among patients continuing to receive specialist NHS addictions treatment. |
| Ethics approval(s) | Bromley London NRES Research Ethics Committee, 05/06/2013, ref: 13/LO/0640 |
| Condition | Opiate dependency |
| Intervention | Personalised Behavioural Intervention (PBI): The PBI will be delivered in 12 one hour sessions weekly. The PBI will be tailored to each clients needs and circumstances. The PBI psychologists on the ARC team at LHH will work with clients using techniques derived and adapted from four core therapeutic approaches below recommended by the National Institute of Clinical Excellence. A menu of additional therapeutic methods will be available for use delivered according to patient preference and clinical indication e.g. 12-step facilitation. 1. Motivational enhancement therapy 2. Cognitive behavioural coping and skills training 3. Contingency management (reinforcement therapy) 4. Community reinforcement approach (network member support for recovery) |
| Intervention type | Other |
| Primary outcome measure | Self-report of heroin use or cocaine use via structured clinical interview and individual diary record, confirmed by rapid-result (on-site) urine screen for morphine and cocaine metabolites. Outcome measures taken at baseline following recruitment into the study and at 14 weeks after recruitment on last day in the study |
| Secondary outcome measures | Current secondary outcome measures as of 02/05/2017: Measured at baseline and at 14 weeks after recruitment on last day in the study 1. Percentage of self-reported heroin and cocaine abstinent days during 28 days prior to final follow-up interview 2.Recorded treatment retention and psychological therapy adherence rates 3. Measures of heroin and cocaine craving 4. Measures of the overall costs associated with PBI/TAU and TAU alone treatment configurations Previous secondary outcome measures: Measured at baseline and at 14 weeks after recruitment on last day in the study: 1. Recorded treatment retention and psychological therapy adherence rates 2. Measures of heroin and cocaine craving 3. Measures of the overall costs associated with PBI/TAU and TAU alone treatment configurations |
| Overall study start date | 05/10/2012 |
| Overall study end date | 20/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 380 |
| Participant inclusion criteria | Current inclusion criteria as of 02/05/2017: 1. 18 years of age or older (no upper limit, but generally <60yrs) 2. Undergoing treatment at Lorraine Hewitt House for a minimum of 6 weeks by the date of randomisation 3. Able to comprehend English to the extent required by the study protocol 4. Demonstrates verbal understanding of the study patient information material 5. Able to provide written consent and can understand and confirm willingness to comply with the protocol 6. Current diagnosis of opioid dependence 7 .Currently prescribed methadone or buprenorphine mono or combination therapy 8. Self reported use heroin and/or cocaine use (verified by urine drug screen toxiology test) 9. Voluntarily seeking treatment and able to attend the clinic as described in the protocol 10. Lives in sufficiently stable accommodation in the community, with a personal phone 11. Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments Previous inclusion criteria: 1. 18 years of age or older (no upper limit, but generally <60 years) 2. Undergoing treatment at Lorraine Hewitt House for a minimum of 6 weeks by the date of randomisation 3. Able to comprehend English to the extent required by the study protocol 4. Demonstrates verbal understanding of the study patient information material 5. Able to provide written consent and can understand and confirm willingness to comply with the protocol 6. Current diagnosis of opioid dependence 7 .Currently prescribed methadone or buprenorphine mono or combination therapy 8. Voluntarily seeking treatment and able to attend the clinic as described in the protocol 9. Lives in sufficiently stable accommodation in the community, with a personal phone 10. Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments |
| Participant exclusion criteria | 1. Clinically significant medical conditions other than addiction that may compromise subject safety or study conduct; or any abnormality which, in the investigator's judgment, is clinically significant. 2. Current criminal justice involvement with legal proceedings and in the opinion of the chief Investigator, is expected to fail to complete the study protocol due to incarceration or relocation from the centre's catchment area 3. Current (past 30 day) suicidal planning or recent (past six months) suicidal ideation or suicide attempt 4. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder - addressed in routine admissions protocol) and/or a history or evidence of organic brain disease or dementia that would compromise the participant's ability to comply with the study protocol 5. Has been in any research study in the past 30 days or an intervention research study in the past 6 months |
| Recruitment start date | 05/06/2013 |
| Recruitment end date | 21/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SW9 8DG
United Kingdom
Sponsor information
University/education
c/o Keith Brennan
1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Two papers will be published in a peer reviewed journal (to be determined) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to conditions of research ethical approvals secured for the study |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/02/2017 | Yes | No | |
| Results article | results | 01/05/2019 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/04/2019: Publication reference added.
12/03/2018: Overall trial end date was changed from 31/03/2017 to 20/04/2018.
16/06/2017: Publication reference added.
07/02/2017: The overall trial end date was changed from 28/02/2016 to 31/03/2017.
