Trial Outcomes & Findings for Buprenorphine Group Medical Visits in Primary Care (NCT NCT02526212)
NCT ID: NCT02526212
Last Updated: 2020-07-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Incarceration
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Buprenorphine Group Medical Visits in Primary Care
Baseline characteristics by cohort
| Measure |
G-BMT, Buprenorphine
n=10 Participants
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
|
Treatment as Usual, Buprenorphine
n=8 Participants
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
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
50.5 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
High School
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
College
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Housing Status
Unstable Housing
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Housing Status
Rental Apartment
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Recent Incarceration
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Unemployed
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Parole
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Alcohol use
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Heroin use
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Any illicit opioid use
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Cocaine use
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Injection drug use
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Intention to treat analysis - missing urine drug toxicology tests are considered to be positive for illicit opioids
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.
Outcome measures
| Measure |
G-BMT, Buprenorphine
n=10 Participants
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
|
Treatment as Usual, Buprenorphine
n=8 Participants
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
|
|---|---|---|
|
Number of Participants With Opioid Abstinence at 8 Weeks
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsRetention 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.
Outcome measures
| Measure |
G-BMT, Buprenorphine
n=10 Participants
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
|
Treatment as Usual, Buprenorphine
n=8 Participants
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
|
|---|---|---|
|
Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months
3 month retention
|
8 Participants
|
7 Participants
|
|
Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months
6 month retention
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 8 week data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm
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.
Outcome measures
| Measure |
G-BMT, Buprenorphine
n=6 Participants
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
|
Treatment as Usual, Buprenorphine
n=6 Participants
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
|
|---|---|---|
|
Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Acceptability data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm
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.
Outcome measures
| Measure |
G-BMT, Buprenorphine
n=6 Participants
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
|
Treatment as Usual, Buprenorphine
n=6 Participants
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
|
|---|---|---|
|
Acceptability (Scale)
|
4.6 units on a scale
Standard Deviation 0.29
|
4.8 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 8 weeksVisit 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
Outcome measures
| Measure |
G-BMT, Buprenorphine
n=10 Participants
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
|
Treatment as Usual, Buprenorphine
n=8 Participants
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
|
|---|---|---|
|
Feasibility (Percentage of Visits Attended)
|
69 percentage of visits attended
Interval 13.0 to 88.0
|
71 percentage of visits attended
Interval 29.0 to 100.0
|
Adverse Events
G-BMT, Buprenorphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual, Buprenorphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aaron Fox, Principal Investigator
Montefiore Medical Center-Albert Einstein College of Medicine
Phone: 718-920-7173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place