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CoMBAT Opioid Use Disorder (CoMBAT OUD)

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ClinicalTrials.gov Identifier: NCT04240093
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Boston University
University of Massachusetts, Boston
National Institute of General Medical Sciences (NIGMS)
Rhode Island Hospital
Information provided by (Responsible Party):
Brown University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Medication-Assisted Treatment Medication Adherence Health Care Utilization Behavioral: Behavioral Activation (BA) Therapy Behavioral: Substance Abuse and Health Navigation Counseling Other: Medications for Opioid Use Disorder Not Applicable

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. We will enroll 80 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. Patient medical records and pharmacy data will also be used to verify self-reported data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Pilot RCT of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Experimental
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral: Behavioral Activation (BA) Therapy
8 sessions of behavioral activation therapy

Behavioral: Substance Abuse and Health Navigation Counseling
2 standard substance abuse and health navigation counseling

Other: Medications for Opioid Use Disorder
Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).

Active Comparator: Standard of Care
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral: Substance Abuse and Health Navigation Counseling
2 standard substance abuse and health navigation counseling

Other: Medications for Opioid Use Disorder
Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).




Primary Outcome Measures :
  1. Days of medication use (engagement in care) [ Time Frame: Baseline, 3 month, 6 month ]
    Self-reported change in the number of days of medication use, confirmed via medical and pharmacy records

  2. Clinic visits completed (engagement in care) [ Time Frame: Baseline, 3 month, 6 month ]
    Self-reported change in the number of office visits attended, confirmed via medical records


Secondary Outcome Measures :
  1. Days of opioid use [ Time Frame: Baseline, 3 month, 6 month ]
    Self-reported change in days of opioid use

  2. Opioid negative urine toxicology screens [ Time Frame: Baseline, 3 month, 6 month ]
    Number of urine toxicology screens negative for opioids (not buprenorphine or methadone)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Initiated medications for opioid use >= 30 day prior to screening
  • Current depressive symptoms
  • Plans to stay in greater Providence area for at least 6-months
  • Able to read, speak, and understand English
  • Willing and able to provide informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240093


Contacts
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Contact: Jaclyn W Hughto, PhD, MPH 401-863-6580 jaclyn_hughto@brown.edu

Locations
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United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Jaclyn W Hughto, PhD, MPH    401-863-6580    jaclyn_hughto@brown.edu   
Principal Investigator: Jaclyn W Hughto, PhD, MPH         
Sponsors and Collaborators
Brown University
Boston University
University of Massachusetts, Boston
National Institute of General Medical Sciences (NIGMS)
Rhode Island Hospital
Investigators
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Principal Investigator: Jaclyn W Hughto, PhD, MPH Brown University
Additional Information:
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT04240093    
Other Study ID Numbers: 1906002463
Junior Investigator Award ( Other Grant/Funding Number: COBRE on Opioids and Overdose )
5P20GM125507-02 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw data for additional analysis will be available to outside individuals through contacting the Multiple Principal Investigators (MPI) at two different times. The first will be after all of the baseline data is collected. We 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 data, we 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' program's web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: The first time point at which outside investigators may request IPD will be after all of the baseline data has been collected and internal study staff have been offered the availability to write papers or give presentations on particular topics. A similar process will take place for outcome data following publication and release of the outcome paper(s). The PI will store the data indefinitely.
Access Criteria: Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI). We 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 data, we will welcome this collaboration. 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 PI's program's web page (see below).
URL: http://www.fresh-research.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents