Opioid-Related Disorders
Conditions
Keywords
opioid use disorder, group counseling, office-based buprenorphine treatment
Brief summary
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
Detailed description
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).
Interventions
BEHAVIORALG-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.
BEHAVIORALTreatment 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.
DRUGBuprenorphine
All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Sponsors
Montefiore Medical Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Currently receiving BMT at Montefiore community health center (CHC). 2. Received BMT for 12 or more weeks. 3. Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent test or in 50% or more of collected tests in the previous 6 months.) 4. Fluent in English of Spanish
Exclusion criteria
1\) Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Abstinence at 8 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | 3 months, 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. |
| Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks | 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. |
| Acceptability (Scale) | 16 weeks | 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. |
| Feasibility (Percentage of Visits Attended) | 8 weeks | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAaron D Fox, MD, MS
Montefiore Medical Center/Albert Einstein College of Medicine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | G-BMT, Buprenorphine | Treatment as Usual, Buprenorphine | Total |
|---|---|---|---|
| Age, Continuous | 54.5 years | 50.5 years | 52 years |
| Alcohol use | 4 Participants | 2 Participants | 6 Participants |
| Any illicit opioid use | 8 Participants | 7 Participants | 15 Participants |
| Cocaine use | 4 Participants | 2 Participants | 6 Participants |
| Education College | 4 Participants | 2 Participants | 6 Participants |
| Education High School | 6 Participants | 6 Participants | 12 Participants |
| Heroin use | 8 Participants | 6 Participants | 14 Participants |
| Housing Status Rental Apartment | 4 Participants | 2 Participants | 6 Participants |
| Housing Status Unstable Housing | 6 Participants | 6 Participants | 12 Participants |
| Injection drug use | 2 Participants | 2 Participants | 4 Participants |
| Parole | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 0 Participants | 0 Participants | 0 Participants |
| Recent Incarceration | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
| Unemployed | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 1 / 8 |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
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.
Time frame: 8 weeks
Population: Intention to treat analysis - missing urine drug toxicology tests are considered to be positive for illicit opioids
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| G-BMT, Buprenorphine | Number of Participants With Opioid Abstinence at 8 Weeks | 0 Participants |
| Treatment as Usual, Buprenorphine | Number of Participants With Opioid Abstinence at 8 Weeks | 1 Participants |
Comparison: Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.p-value: 0.44Fisher Exact
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.
Time frame: 16 weeks
Population: Acceptability data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G-BMT, Buprenorphine | Acceptability (Scale) | 4.6 units on a scale | Standard Deviation 0.29 |
| Treatment as Usual, Buprenorphine | Acceptability (Scale) | 4.8 units on a scale | Standard Deviation 0.19 |
Comparison: Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.p-value: 0.2t-test, 2 sided
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
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-BMT, Buprenorphine | Feasibility (Percentage of Visits Attended) | 69 percentage of visits attended |
| Treatment as Usual, Buprenorphine | Feasibility (Percentage of Visits Attended) | 71 percentage of visits attended |
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.
Time frame: 8 weeks
Population: 8 week data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| G-BMT, Buprenorphine | Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks | 0 Participants |
| Treatment as Usual, Buprenorphine | Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks | 0 Participants |
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.
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| G-BMT, Buprenorphine | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | 6 month retention | 8 Participants |
| G-BMT, Buprenorphine | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | 3 month retention | 8 Participants |
| Treatment as Usual, Buprenorphine | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | 3 month retention | 7 Participants |
| Treatment as Usual, Buprenorphine | Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months | 6 month retention | 6 Participants |