Response to Relapse in Office-Based Opioid Treatment Trial

NCT03812107 | Terminated DMC

• 2 other identifiers: H-381771H79TI081600-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

In a sample of individuals with co-occurring OUD and mental disorders, the investigators plan to test two medications for opioid use disorder (MOUD) treatment protocols that involve differing approaches to the use of opioids and other drugs during and after stabilization on MOUD - intensive vs. moderate treatment.The study is being conducted alongside the opening of a new clinical service funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) known as the Addiction and Behavioral Health Outpatient Recovery (ABOVE) program. The ABOVE Program is designed to treat patients with co-occurring opioid use disorder (OUD) and mental disorders with MOUD. Participants are individuals seeking treatment for co-occurring opioid use disorder (OUD) and mental disorders and are willing to receive MOUD treatment. Potential participants will be screened in the context of clinical care for opioid use disorder and mental disorders. If they are eligible for treatment in the ABOVE program, they will be asked to complete a baseline assessment, again for the purposes of clinical care. After completing the baseline clinical assessment, they will be asked to participate in this clinical trial, consented, then randomized. Treatment is delivered in the context of clinical care which involves delivery of MOUD and can involve psychiatric medications, and group and individual psychotherapy. Difference in treatment between the two randomization arms will only occur if a relapse to drug use occurs and will only involve two protocol-directed treatment responses to relapse.

Conditions

Opioid-use Disorder

Keywords

Opioid-use Disorder (OUD); Medication for OUD (MOUD); Co-occurring opioid use disorder and mental disorders; Office-based Addiction Treatment

Outcome Measures

Primary Outcomes (1)

• Retention in MOUD treatment

  This is a continuous measure of days a participant is prescribed medications for opioid use disorder for 24 weeks. For example, if the first prescription is for 7 days, then this measure has a minimum value of 7 days and a maximum value of approximately 168 days (24 weeks). If a participant is without MOUD prescribed by the ABOVE clinical program for 7 days or greater, then the participant will be considered discontinued from treatment for study purposes.

  24 weeks

Secondary Outcomes (6)

• Number of medications for opioid use disorder provider visits

  24 weeks

• Change in number of days of past 30-day illicit opioid use by self-report from baseline to 24 weeks

  baseline, 24 weeks

• Change in number of days of past 30-day any illicit drug use or heavy drinking days by self-report from baseline to 24 weeks

  baseline, 24 weeks

• Proportion of urine drug tests negative for opioids from baseline to 24 weeks

  24 weeks

• Proportion of urine drug tests negative for any illicit drug from baseline to 24 weeks

  24 weeks

Study Arms (2)

Moderate Treatment Approach

EXPERIMENTAL

Participants in this arm who relapse will be able to move more freely between follow up steps and are hypothesized to require fewer provider visits than those in the intensive treatment arm.

Other: Moderate Treatment Approach

Intensive Treatment Approach

ACTIVE COMPARATOR

Participants in this arm who relapse will follow the current guidelines follow up steps of weekly, then every two weeks and finally monthly provider visits.

Other: Intensive Treatment Approach

Interventions

Moderate Treatment Approach OTHER

The frequency of visits will be organized similarly as the intensive treatment arm (weekly, every 2 weeks, and every 4 weeks) but participants in this arm will be able to move more freely between these steps and are hypothesized to require fewer provider visits than the intensive treatment arm.

Moderate Treatment Approach

Intensive Treatment Approach OTHER

After stabilization on a MOUD, participants who relapse will be asked to return weekly until 2 consecutive urine drug tests are negative for opioids or other illicit drugs. Participants will then be asked to return every other week until 2 consecutive urine drug tests are negative for opioids or other illicit drugs, before being asked to return every 4 weeks. If the participant tests positive for illicit drugs while returning every other week, they will return to the beginning of the treatment plan (2 consecutive negative tests before going to every other week).

Intensive Treatment Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Opioid use disorder \[based on Diagnostic Statistical Manual 5 (DSM5) criteria assessed by clinician interview\]
• Mental disorder (based on DSM5 criteria assessed by clinician interview)
• Willingness to receive treatment with office-based medication for opioid use disorder
• Willingness to name at least 1 contact for follow up purposes
• Enrollment in the ABOVE program

You may not qualify if:

• Pregnancy (urine testing if childbearing potential) or breast feeding
• Suicidal or homicidal ideation that requires immediate attention
• Cognitive dysfunction that precludes informed consent or research staff assessment that participant cannot understand interview questions

Sponsors & Collaborators

• Boston Medical Center: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Christina Borba, PhD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: February 7, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)