Opioid Use DisorderNCT05184907

Effects of RME on Engagement in Buprenorphine Treatment

A study testing Remote Motivational Enhancement (RME) Intervention Arm and Information Only in people with Opioid Use Disorder and Behavioral Symptoms, run by Cambridge Health Alliance at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid Use Disorder, Behavioral Symptoms, Psychiatric or Mood Diseases or Conditions
What is being tested?: Remote Motivational Enhancement (RME) Intervention Arm and Information Only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 1 May 2022to 2 Aug 2023
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18 or older
Meets DSM-IV criteria for opioid dependence or DSM-V criteria for opioid use disorder
Current patient enrolled in Bicycle Health's buprenorphine treatment program
Ability to provide informed consent
Access to the internet and an electronic device to attend remote coaching sessions via videoconferencing and complete online assessments
Sufficient English fluency to understand study procedures and assessments
Completion of the CAT-MH screening modules, BAM, and PSS measures (through CHAMindWell and Bicycle Health's service implementation project)

Who cannot join

Non-English speaking
Reporting active homicidal or suicidal ideation
Exhibits signs of active mania or psychosis
Expected incarceration in next 12 weeks (those that are incarcerated during the study will be withdrawn from the study)
Prisoners
Unable or unwilling to use a mobile device

Show all 10Show fewer

Has a medical contraindication to BUP
Unable to complete screening and baseline assessments
Unstable medical illness that could lead to an expected hospitalization in the next 12 weeks
Third-trimester pregnancy (if a pregnant participant plans to deliver within 12 weeks of study consent)

Trial locations and contacts

1 site in 1 country.

United States1 site

Cambridge Health Alliance
Cambridge, Massachusetts, 02141

Other trials in United States

About this study

Official title: Effects of Remote Motivational Enhancement on Engagement in Buprenorphine Treatment

Read the detailed description

In an effort to assess and address patients' mental health needs, Cambridge Health Alliance has developed an innovative screening program (MindWell) using electronic computerized adaptive testing that will be used among telemedicine patients with opioid use disorder prescribed buprenorphine by Bicycle Health to evaluate needs related to mental health (CAT-MH) and social determinants of health (CAT-SDOH), as well as for stress (Perceived Stress Scale-PSS) and addiction (Brief Addiction Monitor- BAM). This automated screening with adaptive testing helps to identify those who need social services support (e.g. housing, legal, immigration, financial, food, transportation, etc.) or need further comprehensive mental health evaluation and treatment.

Remote Motivational Enhancement (RME) sessions provide telehealth coaching sessions based on motivational interviewing (MI), which is a collaborative, goal-oriented style of communication designed to resolve ambivalence and strengthen intrinsic motivation for a person's commitment to behavior change by eliciting their own reasons for change in an environment of acceptance and compassion. It is an evidence-based and standardized approach that has demonstrated consistently positive clinical outcomes for engagement in wellness, healthcare, and addiction treatment, including effectively improving medical regimen adherence.

This study will randomize Bicycle Health patients prescribed Buprenorphine/Naloxone (B/N) who have been screened the MindWell system to receive either standard care reviewing their screening results with their prescriber or they will receive the opportunity to additionally receive up to 3 RME sessions within a 14 day period. This study investigates the effects of the RME intervention on early engagement in psychosocial aspects of B/N telehealth treatment, rates of opioid overdose, and B/N treatment retention. This study will assess the impact of RME sessions on participants' capacity to achieve behavior change goals related to their individual SDOH needs, mental health symptoms, and/or wellness in OUD recovery goals.

Conditions: Opioid Use Disorder, Behavioral Symptoms, Psychiatric or Mood Diseases or Conditions
Being tested: Remote Motivational Enhancement (RME) Intervention Arm, Information Only
Medical subject headings: Opioid-Related Disorders, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote Motivational Enhancement (RME) Intervention ArmBehavioural
Participants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing within 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Information OnlyOther
Participants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).

Study groups in NCT05184907
Study group	Role	What they receive
RME Intervention Arm	Experimental	Participants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing with 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories). Receives: Behavioral: Remote Motivational Enhancement (RME) Intervention Arm
Information Only Arm	Active comparator	Participants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories). Receives: Other: Information Only

What is being measured

The primary outcome is the main question the study is designed to answer.

Engagement through Action Plan Initiation
1. To examine the effects of RME sessions versus information alone on early engagement in treatment support services as measured by the Action Plan Initiation Survey (APIS-5) with a score of 5-7 representing action plan initiation.
Measured: 4 weeks

Secondary outcomes (3)

Number of Self-Reported and Clinic-Reported Opioid Overdose
To examine the effect of RME versus information alone on the number of self-reported (with and without naloxone administered) and clinic-reported opioid overdoses throughout the 12 weeks of the study.
Measured: 12 weeks
B/N Treatment Retention
To examine the effect of RME versus information alone on retention in buprenorphine OUD treatment with an active prescription at 24 weeks as assessed by an active prescription with Bicycle Health in the past 30 days.
Measured: 24 weeks
Brief Addiction Monitor Scale
To examine the effect of RME versus information alone on change in Brief Addiction Monitor (BAM) subscale scores from 0 to 12 weeks.
1. Drug Use (lower is better outcome)
2. Risk Factors (lower is better outcome) (>12 is considered high risk)
3. Protective Factors (higher is better outcome) (<12 is considered high risk)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20222 Aug 2023

First posted11 Jan 2022
Study start1 May 2022
Primary completion11 Jan 2023
Study completion2 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: RME (1-3 sessions) versus information alone
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05184907
Sponsor's protocol ID: CHA-IRB-21-22-29
Other IDs: R01CE003039
Status last verified: Apr 2024
First submitted: 24 Nov 2021
Last updated: 5 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.

Publications

Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.
PubMed 26030317
Drake C, Yu J, Lurie N, Kraemer K, Polsky D, Chaiyachati KH. Policies to Improve Substance Use Disorder Treatment With Telehealth During the COVID-19 Pandemic and Beyond. J Addict Med. 2020 Sep/Oct;14(5):e139-e141. doi: 10.1097/ADM.0000000000000727.
PubMed 32826619
Gibbons RD, deGruy FV. Without Wasting a Word: Extreme Improvements in Efficiency and Accuracy Using Computerized Adaptive Testing for Mental Health Disorders (CAT-MH). Curr Psychiatry Rep. 2019 Jul 1;21(8):67. doi: 10.1007/s11920-019-1053-9.
PubMed 31264098
Langabeer JR 2nd, Yatsco A, Champagne-Langabeer T. Telehealth sustains patient engagement in OUD treatment during COVID-19. J Subst Abuse Treat. 2021 Mar;122:108215. doi: 10.1016/j.jsat.2020.108215. Epub 2020 Nov 24.
PubMed 33248863
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
PubMed 11392867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Remote Motivational Enhancement on Engagement in Buprenorphine Treatment
ClinicalTrials.gov ID: NCT05184907
Acronym / sponsor ID: CHA-IRB-21-22-29
Conditions: Opioid Use Disorder, Behavioral Symptoms, Psychiatric or Mood Diseases or Conditions
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Cambridge Health AllianceUniversity, hospital or other
Collaborators: University of South Florida, Centers for Disease Control and Prevention
Study start: 1 May 2022 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 2 Aug 2023 (actual)
First posted: 11 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: RME (1-3 sessions) versus information alone

Arm	Type	Receives
RME Intervention Arm	Experimental	Behavioral: Remote Motivational Enhancement (RME) Intervention ArmParticipants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing with 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).
Information Only Arm	Active comparator	Other: Information OnlyParticipants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18 or older
Meets DSM-IV criteria for opioid dependence or DSM-V criteria for opioid use disorder
Current patient enrolled in Bicycle Health's buprenorphine treatment program
Ability to provide informed consent
Access to the internet and an electronic device to attend remote coaching sessions via videoconferencing and complete online assessments

Key exclusion criteria (10 listed)

Non-English speaking
Reporting active homicidal or suicidal ideation
Exhibits signs of active mania or psychosis
Expected incarceration in next 12 weeks (those that are incarcerated during the study will be withdrawn from the study)
Prisoners

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
Remote Motivational Enhancement (RME) Intervention ArmParticipants will discuss the results of their CAT-MH, BAM, and PSS with a coach trained in motivational interviewing within 14 days of study randomization. Based on these results, the coach will help to identify behavior change goals, resolve ambivalence, amplify activation, explore their options, and empower the participant toward taking action to obtain appropriate support services tailored to their individual issues and concerns. The number of RME sessions will range from 1-3, determined by the participant's level of activation and desire to engage in additional sessions, as well as the number of challenges identified in their initial session or determined by their CAT-MH results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).	Behavioural	RME Intervention Arm
Information OnlyParticipants randomized to the information-only arm will have their CAT-MH, BAM, and PSS screening report results sent to their primary B/N prescriber and will encouraged to set up an appointment with their prescriber within 14 days to discuss the results. Participants will be sent a link at the end of week 1 with the aim to complete an action plan questionnaire, in which they will be asked to describe up to 3 action plan goals (in mental health, social services, and stress reduction/mental wellness categories).	Other	Information Only Arm

Primary outcome

Engagement through Action Plan Initiation
Time frame: 4 weeks
1. To examine the effects of RME sessions versus information alone on early engagement in treatment support services as measured by the Action Plan Initiation Survey (APIS-5) with a score of 5-7 representing action plan initiation.

3 secondary outcomes

Number of Self-Reported and Clinic-Reported Opioid Overdose
Time frame: 12 weeks
B/N Treatment Retention
Time frame: 24 weeks
Brief Addiction Monitor Scale
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Background: PubMed 26030317Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.
Background: PubMed 32826619Drake C, Yu J, Lurie N, Kraemer K, Polsky D, Chaiyachati KH. Policies to Improve Substance Use Disorder Treatment With Telehealth During the COVID-19 Pandemic and Beyond. J Addict Med. 2020 Sep/Oct;14(5):e139-e141. doi: 10.1097/ADM.0000000000000727.
Background: PubMed 31264098Gibbons RD, deGruy FV. Without Wasting a Word: Extreme Improvements in Efficiency and Accuracy Using Computerized Adaptive Testing for Mental Health Disorders (CAT-MH). Curr Psychiatry Rep. 2019 Jul 1;21(8):67. doi: 10.1007/s11920-019-1053-9.
Background: PubMed 33248863Langabeer JR 2nd, Yatsco A, Champagne-Langabeer T. Telehealth sustains patient engagement in OUD treatment during COVID-19. J Subst Abuse Treat. 2021 Mar;122:108215. doi: 10.1016/j.jsat.2020.108215. Epub 2020 Nov 24.
Background: PubMed 11392867Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
Individual participant dataSharing planned: Yes. De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.

Related trials for Opioid Use Disorder

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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.

Zev Schuman-Olivier, MD principal investigator

Cambridge Health Alliance

Kathleen Moore, PhD principal investigator

University of South Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 5 Apr 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Engagement through Action Plan Initiation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184907, which also lists 5 linked publications.

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 5 Apr 2024.