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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA039041 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary goal of this research is to improve the effectiveness of buprenorphine maintenance treatment (BMT) within primary care.
Investigators propose that providing BMT as part of a group medical visit (instead of an individual visit) will improve treatment outcomes for patients with persistent opioid abuse, because members become accountable to the group, are exposed to beneficial habits of others (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly with medical management
Investigators have developed a preliminary model of BMT group medical visits, conducted focus groups with BMT patients and providers, and will use this data to develop a manualized group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy, acceptability, and feasibility. Participants who have persistent opioid abuse while receiving BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5 groups) or to intensify BMT (treatment as usual) with their individual primary care physician (40 participants).
Hypothesis: In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs. treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and adherence to medical visits (feasibility).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-BMT, Buprenorphine | Experimental | This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. |
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| Treatment as usual, Buprenorphine | Active Comparator | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-BMT | Behavioral | The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Opioid Abstinence at 8 Weeks | Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | Retention is defined as having a medical visit or active buprenorphine prescription 12-16 weeks (3 month retention) and 24-28 weeks (6 month retention) after protocol initiation. | 3 months, 6 months |
| Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
1) Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Aaron D Fox, MD, MS | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Health Care Center | The Bronx | New York | 10451 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | G-BMT, Buprenorphine | This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
| FG001 | Treatment as Usual, Buprenorphine | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | G-BMT, Buprenorphine | This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Opioid Abstinence at 8 Weeks | Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone. | Intention to treat analysis - missing urine drug toxicology tests are considered to be positive for illicit opioids | Posted | Count of Participants | Participants | 8 weeks |
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Medical record review was conducted after 24 weeks had elapsed following enrollment.
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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 | G-BMT, Buprenorphine | This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. G-BMT: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
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Due to the small sample size, several analyses were not conducted as planned. Narrow inclusion criteria limited recruitment. Though efficacy data is limited, this pilot study did provide useful information about group feasibility and acceptability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Fox, Principal Investigator | Montefiore Medical Center-Albert Einstein College of Medicine | 718-920-7173 | adfox@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2018 | Jun 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
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| Treatment as usual | Behavioral | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. |
|
| Buprenorphine | Drug | All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
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|
We used the HIV risk measure from the NIDA Seek, Test, Treat, and Retain for Vulnerable Populations study. Items for sexual risk behavior are from the Women's Health CoOp Baseline Questionnaire. Items for injection risk behavior are from the STTR Criminal Justice instrument. We will report the number of participants reporting sharing of injection equipment at 8 weeks following enrollment. |
| 8 weeks |
| Acceptability (Scale) | Satisfaction with BMT will be measured on a 5-point Likert scale for participants following completion of the intervention. We used 17 items from the Primary Care Buprenorphine Satisfaction Scale. Each item addressed satisfaction with a specific component of buprenorphine treatment, which participants rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). A higher score indicates greater satisfaction. | 16 weeks |
| Feasibility (Percentage of Visits Attended) | Visit adherence will be measured as the number of buprenorphine visits attended divided by the number of buprenorphine visits required per protocol and multiplied by 100 to give a percentage | 8 weeks |
| Death |
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| BG001 | Treatment as Usual, Buprenorphine | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education | College = completed some college or graduated | Count of Participants | Participants |
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| Housing Status | Unstable housing = homeless, shelter, single-room occupancy hotel, living with friend or family | Count of Participants | Participants |
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| Recent Incarceration | Spent one or more day in jail or prison in the 90 days before enrollment | Count of Participants | Participants |
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| Unemployed | Count of Participants | Participants |
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| Parole | Count of Participants | Participants |
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| Alcohol use | Reported alcohol use on at least one day in 30 days before enrollment | Count of Participants | Participants |
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| Heroin use | Reported heroin use on at least one day in 30 days before enrollment | Count of Participants | Participants |
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| Any illicit opioid use | Reported use of heroin, non-prescribed methadone, or non-prescribed opioid analgesics on at least one day in 30 days before enrollment | Count of Participants | Participants |
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| Cocaine use | Reported cocaine use on at least one day in 30 days before enrollment | Count of Participants | Participants |
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| Injection drug use | Reported injection drug use on at least one day in 30 days before enrollment | Count of Participants | Participants |
|
| OG001 | Treatment as Usual, Buprenorphine | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone |
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|
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| Secondary | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | Retention is defined as having a medical visit or active buprenorphine prescription 12-16 weeks (3 month retention) and 24-28 weeks (6 month retention) after protocol initiation. | Posted | Count of Participants | Participants | 3 months, 6 months |
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|
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| Secondary | Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks | We used the HIV risk measure from the NIDA Seek, Test, Treat, and Retain for Vulnerable Populations study. Items for sexual risk behavior are from the Women's Health CoOp Baseline Questionnaire. Items for injection risk behavior are from the STTR Criminal Justice instrument. We will report the number of participants reporting sharing of injection equipment at 8 weeks following enrollment. | Data for this outcome measure was missing from 4 participants in the G-BMT arm and 2 participants in Treatment as usual arm. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Acceptability (Scale) | Satisfaction with BMT will be measured on a 5-point Likert scale for participants following completion of the intervention. We used 17 items from the Primary Care Buprenorphine Satisfaction Scale. Each item addressed satisfaction with a specific component of buprenorphine treatment, which participants rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). A higher score indicates greater satisfaction. | Acceptability data was missing from 4 participants in both the G-BMT arm and 2 participants in the Treatment as usual arm. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
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| Secondary | Feasibility (Percentage of Visits Attended) | Visit adherence will be measured as the number of buprenorphine visits attended divided by the number of buprenorphine visits required per protocol and multiplied by 100 to give a percentage | Posted | Median | Inter-Quartile Range | percentage of visits attended | 8 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Treatment as Usual, Buprenorphine | Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Treatment as usual: Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone | 1 | 8 | 0 | 8 | 0 | 8 |
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |