Condition category
Mental and Behavioural Disorders
Date applied
13/05/2013
Date assigned
23/05/2013
Last edited
10/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 drug, in their 6th treatment week. 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. They 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 March 2017

Who is funding the study?
Action on Addiction (UK)

Who is the main contact
Prof. John Marsden
john.marsden@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Marsden

ORCID ID

http://orcid.org/0000-0002-1307-2498

Contact details

Addictions Department
Institute of Psychiatry
Box 48
Addiction Sciences Building
De Crespigny Park
London
SE5 8AF
United Kingdom
-
john.marsden@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ARC2_LHH_2013

Study information

Scientific title

The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder: a randomised controlled trial

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

Bromley London NRES Research Ethics Committee, 05/06/2013, ref: 13/LO/0640

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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 client’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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

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 trial start date

05/10/2012

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

380

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

United Kingdom

Trial participating centre

Lorraine Hewitt House
London
SW9 8DG
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Keith Brennan
1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Action on Addiction

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

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

Intention to publish date

30/06/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/02/2017: The overall trial end date was changed from 28/02/2016 to 31/03/2017.