Opioid-use DisorderCoMBAT_OUDNCT04240093

CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder

A study testing Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling and Medications for Opioid Use Disorder in people with Opioid-use Disorder and Medication Adherence, run by Brown University 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid-use Disorder, Medication Adherence, Health Care Utilization
What is being tested?: Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling and Medications for Opioid Use Disorder
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2019to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years or older
Initiated medications for opioid use >= 30 day prior to screening
Current depressive symptoms
Plans to stay in Rhode Island or Massachusetts for at least 6-months
Able to read, speak, and understand English
Willing and able to provide informed consent

Who cannot join

Does not plan to continue taking medications for opioid use disorder
Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
Discovery of active suicidal ideation at the time of interview
In the second or third trimester of pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Brown University
Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder

This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.

Read the detailed description

Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes.

This study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.

Conditions: Opioid-use Disorder, Medication Adherence, Health Care Utilization
Being tested: Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling, Medications for Opioid Use Disorder
Keywords: Medications for opioid use disorder, Methadone, Buprenorphine, Behavioral Activation
Medical subject headings: Opioid-Related Disorders, Medication Adherence, Patient Acceptance of Health Care

What participants receive

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

Behavioral Activation (BA) TherapyBehavioural
8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation CounselingBehavioural
2 standard substance abuse and health navigation counseling
Medications for Opioid Use DisorderOther
Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).

Study groups in NCT04240093
Study group	Role	What they receive
Experimental	Experimental	Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Receives: Behavioral: Behavioral Activation (BA) Therapy; Behavioral: Substance Abuse and Health Navigation Counseling; Other: Medications for Opioid Use Disorder
Standard of Care	Active comparator	Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Receives: Behavioral: Substance Abuse and Health Navigation Counseling; Other: Medications for Opioid Use Disorder

What is being measured

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

Number of Missed Medication Doses - Past 30 Days
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Measured: Baseline, 3 month follow-up, and 6 month follow-up
Number of Missed Medication-related Visits - Past 30 Days
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.
Measured: Baseline, 3 month follow-up, and 6 month follow-up

Secondary outcomes (1)

Fentanyl and Opiate-positive Urine Toxicology Screen
Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)
Measured: Baseline, 3 month follow-up, and 6 month follow-up

Timeline

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

15 Nov 201931 Mar 2022

First posted27 Jan 2020
Study start15 Nov 2019
Primary completion18 Feb 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by Brown UniversityThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04240093
Sponsor's protocol ID: 1906002463
Other IDs: Junior Investigator Award, 5P20GM125507-02
Acronym: CoMBAT_OUD
Status last verified: May 2023
First submitted: 21 Jan 2020
Last updated: 26 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI) at two different times. The first will be after all of the baseline data is collected. The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze the data, the PI will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PIs' web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.

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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All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
ClinicalTrials.gov ID: NCT04240093
Acronym / sponsor ID: CoMBAT_OUD / 1906002463
Conditions: Opioid-use Disorder, Medication Adherence, Health Care Utilization
Keywords: Medications for opioid use disorder, Methadone, Buprenorphine, Behavioral Activation
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: Boston University, University of Massachusetts, Boston, National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital
Study start: 15 Nov 2019 (actual)
Primary completion: 18 Feb 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 27 Jan 2020 (actual)
Results: Posted 26 May 2023

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: Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.

Arm	Type	Receives
Experimental	Experimental	Behavioral: Behavioral Activation (BA) Therapy, Behavioral: Substance Abuse and Health Navigation Counseling, Other: Medications for Opioid Use DisorderExperimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Standard of Care	Active comparator	Behavioral: Substance Abuse and Health Navigation Counseling, Other: Medications for Opioid Use DisorderSubstance Abuse and Health Navigation Counseling (2 sessions) + Meds

Who may qualify

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

Key inclusion criteria (6 listed)

Age 18 years or older
Initiated medications for opioid use >= 30 day prior to screening
Current depressive symptoms
Plans to stay in Rhode Island or Massachusetts for at least 6-months
Able to read, speak, and understand English

Key exclusion criteria (4 listed)

Does not plan to continue taking medications for opioid use disorder
Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
Discovery of active suicidal ideation at the time of interview
In the second or third trimester of pregnancy

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
Behavioral Activation (BA) Therapy8 sessions of behavioral activation therapy	Behavioural	Experimental
Substance Abuse and Health Navigation Counseling2 standard substance abuse and health navigation counseling	Behavioural	Experimental, Standard of Care
Medications for Opioid Use DisorderMedications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).	Other	Experimental, Standard of Care

Primary outcome

Number of Missed Medication Doses - Past 30 Days
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Number of Missed Medication-related Visits - Past 30 Days
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.

1 secondary outcome

Fentanyl and Opiate-positive Urine Toxicology Screen
Time frame: Baseline, 3 month follow-up, and 6 month follow-up

Results and safety

Results posted to the registry on 26 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	16	16
Standard of Care	16	16

Primary outcome: Number of Missed Medication Doses - Past 30 Days

Time frame: Baseline, 3 month follow-up, and 6 month follow-up. Mean (Standard Deviation). Unit: Number of missed doses

Measure	CoMBAT (Experimental) n = 16	Standard of Care (SOC; Control) n = 16
Baseline	3.13 (3.48)	2.81 (3.00)
3 Month Follow-Up	3.71 (4.41)	2.25 (3.00)
6 Month Follow-Up	1.19 (2.43)	1.69 (4.29)

CoMBAT (Experimental) vs Standard of Care (SOC; Control): Beta coefficient: -0.46 (95% CI -1.11 to 0.20), p = 0.17, Generalized estimating equations (GEE)

Population analysed: Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.

Primary outcome: Number of Missed Medication-related Visits - Past 30 Days

Time frame: Baseline, 3 month follow-up, and 6 month follow-up. Mean (Standard Deviation). Unit: Number of missed visits

Measure	CoMBAT (Experimental) n = 16	Standard of Care (SOC; Control) n = 16
Baseline	1.13 (1.20)	0.94 (0.85)
3 Month Follow-Up	0.14 (0.36)	0.25 (0.45)
6 Month Follow-Up	0.06 (0.03)	0.06 (0.35)

CoMBAT (Experimental) vs Standard of Care (SOC; Control): Beta coefficient: -0.18 (95% CI -3.09 to 2.72), p = 0.90, Generalized estimating equation (GEE)

Population analysed: Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Standard of Care	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FRESH Research LabLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI) at two different times. The first will be after all of the baseline data is collected. The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze the data, the PI will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PIs' web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.

Related trials for Opioid-use Disorder

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Not yet recruiting
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Recruiting
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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.

Jaclyn W Hughto, PhD, MPH principal investigator

Brown University

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 6 inclusion and 4 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 26 May 2023. 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?

Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Missed Medication Doses - Past 30 Days (time frame: Baseline, 3 month follow-up, and 6 month follow-up). The study lists 2 primary outcomes in all. 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 NCT04240093.

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 26 May 2023.