Opioid-use DisorderRR-OBOTNCT03812107
Response to Relapse in Office-Based Opioid Treatment Trial
A study testing Moderate Treatment Approach and Intensive Treatment Approach in people with Opioid-use Disorder, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Moderate Treatment Approach and Intensive Treatment Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Moderate Treatment Approach, Intensive Treatment Approach
- Keywords
- Opioid-use Disorder (OUD), Medication for OUD (MOUD), Co-occurring opioid use disorder and mental disorders, Office-based Addiction Treatment
- Medical subject headings
- Opioid-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Treatment ApproachOther
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.
Intensive Treatment ApproachOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intensive Treatment Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (6)
Number of medications for opioid use disorder provider visits
The number of provider visits attended will be recorded for each participant. Types of provider visits include visits with a nurse, psychiatrist, nurse practitioner, or mental health clinician for either individual or group psychotherapy.
Measured: 24 weeks
Change in number of days of past 30-day illicit opioid use by self-report from baseline to 24 weeks
Participants will be asked the number of days of illicit opioid use (includes use of non-prescribed opioid analgesics) in the past 30 days at baseline and 24 week follow-up. This outcome will be the difference in the number of days of illicit opioid use between baseline and 24 weeks.
Measured: 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
Participants will be asked the number of days of any illicit drug use or heavy drinking days (5 or more alcoholic drinks in one sitting for males or 4 or more alcohol drinks in one sitting for females) in the past 30 days at baseline and 6 month follow-up. This outcome will be the difference in the number of days of any illicit drug use or heavy drinking days between baseline and 6 months.
Measured: baseline, 24 weeks
Proportion of urine drug tests negative for opioids from baseline to 24 weeks
Participants will be asked to provide urine drug tests that test for illicit drugs including illicit opioids at least once every 4 weeks from baseline to 24 weeks. Because urine drug tests will only be obtained on clinical visit days and the two arms may have a different number of urine drug tests obtained per participant, only monthly or near-monthly drug tests in each arm (week 4, week 8, week 12, etc.) will be included in the study.
Measured: 24 weeks
Proportion of urine drug tests negative for any illicit drug from baseline to 24 weeks
Participants will be asked to provide urine drug tests that test for illicit drugs including amphetamines, barbiturates, cocaine, benzodiazepines, opioids (including opiates, fentanyl, oxycodone, methadone), at least once every 4 weeks from baseline to 24 weeks. Because urine drug tests will only be obtained on clinical visit days and the two arms may have a different number of urine drug tests obtained per participant, only monthly or near-monthly drug tests in each arm (week 4, week 8, week 12, etc.) will be included in the study.
Measured: 24 weeks
Participant satisfaction using the TPQ
The Treatment Perceptions Questionnaire (TPQ) is a 10-item questionnaire with Likert scale responses from 0 to 4 it also allows open-responses / feedback. Potential range of scores is from 0 to 40 and higher scores indicate greater satisfaction
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start7 Feb 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: The study was stopped due to COVID-19 as it interfered with the study intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Christina Borba, PhD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812107
- Sponsor's protocol ID
- H-38177
- Other IDs
- 1H79TI081600-01
- Acronym
- RR-OBOT
- Status last verified
- Dec 2021
- First submitted
- 18 Jan 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Relapse in Office-Based Opioid Treatment Trial
- ClinicalTrials.gov ID
- NCT03812107
- Acronym / sponsor ID
- RR-OBOT / H-38177
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to COVID-19 as it interfered with the study intervention.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Treatment Approach | Experimental | Other: Moderate Treatment ApproachParticipants 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. |
| Intensive Treatment Approach | Active comparator | Other: Intensive Treatment ApproachParticipants in this arm who relapse will follow the current guidelines follow up steps of weekly, then every two weeks and finally monthly provider visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Treatment ApproachThe 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. | Other | Moderate Treatment Approach |
| Intensive Treatment ApproachAfter 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). | Other | Intensive Treatment Approach |
Primary outcome
Retention in MOUD treatment
Time frame: 24 weeks
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.
6 secondary outcomes
Number of medications for opioid use disorder provider visits
Time frame: 24 weeks
Change in number of days of past 30-day illicit opioid use by self-report from baseline to 24 weeks
Time frame: 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
Time frame: baseline, 24 weeks
Proportion of urine drug tests negative for opioids from baseline to 24 weeks
Time frame: 24 weeks
Proportion of urine drug tests negative for any illicit drug from baseline to 24 weeks
Time frame: 24 weeks
Participant satisfaction using the TPQ
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: The study was stopped due to COVID-19 as it interfered with the study intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Borba, PhD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Treatment Approach and Intensive Treatment Approach in people with Opioid-use Disorder, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to COVID-19 as it interfered with the study intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in MOUD treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.