Response to Relapse in Office-Based Opioid Treatment Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | February 7, 2019 |
| End Date: | July 2022 |
| Contact: | Tae Woo Park, MD |
| Email: | taewoo.park@bmc.org |
| Phone: | 617-414-1906 |
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.
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.
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.
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.
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
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