Trial Outcomes & Findings for Onsite Buprenorphine Treatment at Syringe Exchange Programs (NCT NCT03150173)
NCT ID: NCT03150173
Last Updated: 2025-12-11
Results Overview
Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.
COMPLETED
PHASE2
97 participants
30 days after randomization
2025-12-11
Participant Flow
211 participants were screened and 97 were randomized into the study. Of the 114 participants who were not enrolled into the study, 98 participants did not meet all of the eligibility criteria, 13 did not show up for the enrollment visit and 3 participants signed the informed consent form but were not randomized into the study.
Participant milestones
| Measure |
O-BMT (Onsite Treatment)
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
|
Overall Study
COMPLETED
|
35
|
44
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
O-BMT (Onsite Treatment)
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
5
|
Baseline Characteristics
Onsite Buprenorphine Treatment at Syringe Exchange Programs
Baseline characteristics by cohort
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 9.9 • n=237 Participants
|
43.3 years
STANDARD_DEVIATION 11.3 • n=243 Participants
|
42.0 years
STANDARD_DEVIATION 10.6 • n=480 Participants
|
|
Sex/Gender, Customized
Male
|
38 Participants
n=237 Participants
|
38 Participants
n=243 Participants
|
76 Participants
n=480 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
19 Participants
n=480 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Sex/Gender, Customized
Refuse to answer
|
1 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Hispanic Black
|
12 Participants
n=237 Participants
|
4 Participants
n=243 Participants
|
16 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Hispanic White
|
5 Participants
n=237 Participants
|
4 Participants
n=243 Participants
|
9 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Hispanic Other
|
13 Participants
n=237 Participants
|
14 Participants
n=243 Participants
|
27 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
6 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
16 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
11 Participants
n=237 Participants
|
13 Participants
n=243 Participants
|
24 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
1 Participants
n=237 Participants
|
4 Participants
n=243 Participants
|
5 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=237 Participants
|
49 participants
n=243 Participants
|
97 participants
n=480 Participants
|
|
Mental Health Condition
|
22 Participants
n=237 Participants
|
22 Participants
n=243 Participants
|
44 Participants
n=480 Participants
|
|
Intravenous Drug Use
|
28 Participants
n=237 Participants
|
33 Participants
n=243 Participants
|
61 Participants
n=480 Participants
|
|
Buprenorphine Use
|
19 Participants
n=237 Participants
|
16 Participants
n=243 Participants
|
35 Participants
n=480 Participants
|
|
Amphetamine Use
|
0.2 days
STANDARD_DEVIATION 0.8 • n=237 Participants
|
0.9 days
STANDARD_DEVIATION 4.4 • n=243 Participants
|
0.6 days
STANDARD_DEVIATION 2.7 • n=480 Participants
|
|
Opioid Use Disorder (OUD) Criteria
|
10.5 criteria
STANDARD_DEVIATION 2.1 • n=237 Participants
|
10.8 criteria
STANDARD_DEVIATION 2.2 • n=243 Participants
|
10.7 criteria
STANDARD_DEVIATION 2.2 • n=480 Participants
|
|
Heroin use
|
23.3 days
STANDARD_DEVIATION 11.3 • n=237 Participants
|
24.2 days
STANDARD_DEVIATION 10.1 • n=243 Participants
|
23.8 days
STANDARD_DEVIATION 10.7 • n=480 Participants
|
|
Methadone Use
|
2.0 days
STANDARD_DEVIATION 7.3 • n=237 Participants
|
0.6 days
STANDARD_DEVIATION 1.7 • n=243 Participants
|
1.3 days
STANDARD_DEVIATION 4.5 • n=480 Participants
|
|
Opioid or Analgesic Use
|
3.3 days
STANDARD_DEVIATION 8.5 • n=237 Participants
|
3.3 days
STANDARD_DEVIATION 8.4 • n=243 Participants
|
3.3 days
STANDARD_DEVIATION 8.4 • n=480 Participants
|
|
Alcohol Use
|
1.6 days
STANDARD_DEVIATION 4.9 • n=237 Participants
|
1.3 days
STANDARD_DEVIATION 2.5 • n=243 Participants
|
1.4 days
STANDARD_DEVIATION 3.7 • n=480 Participants
|
|
Cocaine Use
|
10.0 days
STANDARD_DEVIATION 11.4 • n=237 Participants
|
12.6 days
STANDARD_DEVIATION 12.2 • n=243 Participants
|
11.3 days
STANDARD_DEVIATION 11.8 • n=480 Participants
|
|
Polysubstance Use
|
11.0 days
STANDARD_DEVIATION 12.3 • n=237 Participants
|
12.0 days
STANDARD_DEVIATION 13.3 • n=243 Participants
|
11.5 days
STANDARD_DEVIATION 12.8 • n=480 Participants
|
PRIMARY outcome
Timeframe: 30 days after randomizationPopulation: Intention to treat (ITT) analysis design. All participants, including those who are lost to follow-up, are included in the analysis.
Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Buprenorphine Engagement
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTreatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Treatment Retention
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: HIV Risk behavior data was unable to be collected from 12 participants in the onsite buprenorphine treatment (O-BMT) study arm and 9 participants in the Enhanced referral study arm. Accordingly, there is no HIV risk behavior data to report for these participants.
Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection risk, will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=36 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=40 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
HIV Risk Behaviors
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsBuprenorphine diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Buprenorphine Diversion
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure).
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=97 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Incremental Cost-effectiveness Ratio (ICER)
|
-805067 Ratio (US dollars/QALY)
|
—
|
SECONDARY outcome
Timeframe: 6 monthsThe main economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. Mean years gained are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Quality-adjusted Life-years (QALYs) Gained
|
0.20 years gained
Interval 0.18 to 0.21
|
0.17 years gained
Interval 0.15 to 0.19
|
SECONDARY outcome
Timeframe: 6 monthsMean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Mean Difference in Total Costs
|
2702.43 US Dollars
Interval 1280.77 to 6825.75
|
26853.97 US Dollars
Interval 7001.37 to 146995.55
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Time to first buprenorphine prescription results data was only available, and reported, from the sub-group of participants that received a prescription.
Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=36 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=29 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Time to First Buprenorphine Prescription
|
3.0 days
Standard Deviation 4.6
|
14.0 days
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 6 monthsThe Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=48 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Number/Percentage of Participants Who Received Any Buprenorphine Prescription
|
36 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Total time prescribed buprenorphine results data was only available, and reported, from the sub-group of participants that received a prescription.
Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=36 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=29 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Total Time Prescribed Buprenorphine
|
46.7 days
Standard Deviation 32.9
|
56.6 days
Standard Deviation 34.8
|
POST_HOC outcome
Timeframe: 30 days after randomizationPopulation: Self-reported buprenorphine use data was unable to be collected from 20 participants in the onsite buprenorphine treatment (O-BMT) study arm and 15 participants in the Enhanced referral study arm.
Buprenorphine Adherence (self-reported), defined as meeting the primary outcome of buprenorphine engagement and self-reporting buprenorphine use at 30 days, was assessed as a composite measure for sensitivity analysis. The number of participants who both maintained an active buprenorphine prescription at 30 days after randomization, based on a dichotomous (i.e., Yes/No) measure, AND self-reported having taken buprenorphine on 1 or more days during the 30-day period were tabulated. Data are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=28 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=34 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Buprenorphine Adherence (Self-reported)
|
13 Participants
|
13 Participants
|
POST_HOC outcome
Timeframe: 30 days after randomizationPopulation: Urine samples were unable to be collected from 26 participants in the onsite buprenorphine treatment (O-BMT) study arm and 23 participants in the Enhanced Referral study arm. As such, an assessment was unable to be made for these participants.
Buprenorphine Adherence (confirmed) was defined as meeting the primary outcome and having a urine drug screen positive for buprenorphine at 30 days. This outcome was assessed as a composite measure for sensitivity analysis. The number of participants who both maintained an active buprenorphine prescription at 30 days after randomization, based on a dichotomous (i.e., Yes/No) measure, AND tested positive for Buprenorphine in their urine sample following the 30-day period were tabulated. Data are summarized by study arm.
Outcome measures
| Measure |
O-BMT (Onsite Treatment)
n=22 Participants
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=26 Participants
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Buprenorphine Adherence (Confirmed)
|
5 Participants
|
8 Participants
|
Adverse Events
O-BMT (Onsite Treatment)
Enhanced Referral
Serious adverse events
| Measure |
O-BMT (Onsite Treatment)
n=48 participants at risk
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 participants at risk
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Injury, poisoning and procedural complications
Opioid Overdose
|
0.00%
0/48 • 24 weeks
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Skin Infection (Abscess)
|
2.1%
1/48 • Number of events 1 • 24 weeks
|
0.00%
0/49 • 24 weeks
|
|
Infections and infestations
Skin Infection (Methicillin-resistant Staphylococcus aureus)
|
0.00%
0/48 • 24 weeks
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
O-BMT (Onsite Treatment)
n=48 participants at risk
Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment
Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Buprenorphine: all participants will receive buprenorphine
|
Enhanced Referral
n=49 participants at risk
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Buprenorphine: all participants will receive buprenorphine
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
2.1%
1/48 • 24 weeks
|
2.0%
1/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Transportation Accident
|
0.00%
0/48 • 24 weeks
|
2.0%
1/49 • 24 weeks
|
|
Infections and infestations
Endometriosis pain
|
2.1%
1/48 • 24 weeks
|
0.00%
0/49 • 24 weeks
|
Additional Information
Dr. Aaron D. Fox, Professor, General Internal Medicine
Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place