Clinical trial NCT03812107: Response to Relapse in Office-Based Opioid Treatment Trial
Official title: Response to Relapse in Office-Based Opioid Treatment Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2019-01-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study is a single-center, two-arm, 6-month (24-week), parallel group, open-label, randomized controlled trial to examine the effectiveness of two approaches to managing relapse to illicit drug use in treatment with medications for opioid use disorder (MOUD). It will compare two treatment protocols for treatment of opioid use disorder with medications. The two protocols involve differing approaches to relapse to use of illicit drugs in a sample of individuals with co-occurring OUD and mental disorders.

Intensive Treatment Approach: After stabilization on a medication for OUD (MOUD), if a participant tests positive for opioids or other illicit drugs, they 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).

Moderate treatment approach: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Retention in MOUD treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of medications for opioid use disorder provider visits
timeFrame: 24 weeks
measure: Change in number of days of past 30-day illicit opioid use by self-report from baseline to 24 weeks
timeFrame: baseline, 24 weeks
measure: 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
timeFrame: baseline, 24 weeks
measure: Proportion of urine drug tests negative for opioids from baseline to 24 weeks
timeFrame: 24 weeks
measure: Proportion of urine drug tests negative for any illicit drug from baseline to 24 weeks
timeFrame: 24 weeks
measure: Participant satisfaction using the TPQ
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Christina Borba, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: