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| ID | Type | Description | Link |
|---|---|---|---|
| Junior Investigator Award | Other Grant/Funding Number | COBRE on Opioids and Overdose | |
| 5P20GM125507-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Boston University | OTHER |
| University of Massachusetts, Boston | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
| Rhode Island Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds |
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| Standard of Care | Active Comparator | Substance Abuse and Health Navigation Counseling (2 sessions) + Meds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) Therapy | Behavioral | 8 sessions of behavioral activation therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 3 month follow-up, and 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3 month follow-up, and 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclyn W Hughto, PhD, MPH | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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| Label | URL |
|---|---|
| FRESH Research Lab | View source |
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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.
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.
Raw data for additional analysis will be available to outside individuals by contacting the Principal Investigator (PI). 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 data, the PI 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 web page (see below).
A total of 44 individuals consented; of these, 12 individuals were lost to follow-up prior to randomization, resulting in a randomized sample of 32 participants (16 CoMBAT experimental arm; 16 Standard of Care control arm).
Participants were recruited via ads posted online (i.e., Craigslist) and in-person at outpatient substance use treatment clinics and community organizations serving people who use drugs in Rhode Island and Massachusetts. Substance use treatment providers and staff also provided direct referrals and snowball sampling was used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2020 | Dec 1, 2021 |
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| OTHER |
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.
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| Substance Abuse and Health Navigation Counseling | Behavioral | 2 standard substance abuse and health navigation counseling |
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| Medications for Opioid Use Disorder | Other | Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study). |
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| FG001 | Standard of Care | Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). |
| 3 Month Follow-Up |
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| 6 Month Follow Up |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline data are reported for all enrolled and randomized participants (n=32).
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). |
| BG001 | Standard of Care | Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Medication Type | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Number of missed doses | Baseline, 3 month follow-up, and 6 month follow-up |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Number of missed visits | Baseline, 3 month follow-up, and 6 month follow-up |
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| Secondary | 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) | Intent to Treat Analysis. For the raw count data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit. | Posted | Count of Participants | Participants | Baseline, 3 month follow-up, and 6 month follow-up |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | Standard of Care | Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling 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). | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaclyn White Hughto, PhD, MPH | Brown University | 401-863-6580 | jaclyn_hughto@brown.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2023 | May 23, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2020 | Dec 1, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D055118 | Medication Adherence |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Buprenorphine |
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| 3 Month Follow-Up |
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| 6 Month Follow-Up |
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This is a pilot intervention trial and was not powered to detect statistical significance.
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