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

Not Applicable

Completed

• Conditions: Opiate dependency; Mental and Behavioural Disorders

• Registration Number: ISRCTN69313751
• Lead Sponsor: King's College London (UK)

Brief Summary

1. 2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27940188 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30952568

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-23
• Study Completion: 2018-04-20
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> Current secondary outcome measures as of 02/05/2017:<br> Measured at baseline and at 14 weeks after recruitment on last day in the study<br> 1. Percentage of self-reported heroin and cocaine abstinent days during 28 days prior to final follow-up interview<br> 2.Recorded treatment retention and psychological therapy adherence rates<br> 3. Measures of heroin and cocaine craving<br> 4. Measures of the overall costs associated with PBI/TAU and TAU alone treatment configurations<br><br> Previous secondary outcome measures:<br> Measured at baseline and at 14 weeks after recruitment on last day in the study:<br> 1. Recorded treatment retention and psychological therapy adherence rates<br> 2. Measures of heroin and cocaine craving<br> 3. Measures of the overall costs associated with PBI/TAU and TAU alone treatment configurations<br>