The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder

• Register: ISRCTN
• Last refreshed on: 5 May 2019
• Main ID: ISRCTN69313751
• Date of registration: 23/05/2013
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder
• Scientific title: The Addiction Recovery Clinic (ARC): personalised behavioural intervention for opioid use disorder: a randomised controlled trial
• Date of first enrolment: 05/06/2013
• Target sample size: 380
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN69313751
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: John Marsden

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Opiate dependency
Mental and Behavioural Disorders
Opiate dependency

Intervention(s)

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)

Primary Outcome(s)

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(s)

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

Secondary ID(s)

ARC2_LHH_2013

Source(s) of Monetary Support

Action on Addiction

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 20/04/2018