A Phase 2 interventional study of Onsite treatment and Enhanced referral in Opiate Addiction, sponsored by Montefiore Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Treatment
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, 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. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 97 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Onsite treatment · Drug: Buprenorphine
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Behavioral: Enhanced referral · Drug: Buprenorphine
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.
Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
all participants will receive buprenorphine
Buprenorphine Engagement
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.
Time frame: 30 days after randomization
Treatment Retention
Treatment 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.
Time frame: 6 months
HIV Risk Behaviors
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.
Time frame: 6 months
Buprenorphine Diversion
Buprenorphine 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.
Time frame: 6 months
Incremental Cost-effectiveness Ratio (ICER)
The 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).
Time frame: 6 months
Quality-adjusted Life-years (QALYs) Gained
The 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.
Time frame: 6 months
Mean Difference in Total Costs
Mean 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.
Time frame: 6 months
Time to First Buprenorphine 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.
Time frame: 1 month
Number/Percentage of Participants Who Received Any Buprenorphine Prescription
The 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.
Time frame: 6 months
Total Time Prescribed Buprenorphine
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.
Time frame: 6 months
| Milestone | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Started | 48 | 49 |
| Completed | 35 | 44 |
| Not completed | 13 | 5 |
| Withdrew: Lost to follow-up | 13 | 5 |
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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Buprenorphine Engagement | 19 | 19 |
Treatment 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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Treatment Retention | 2 | 6 |
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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| HIV Risk Behaviors | 5 | 4 |
Buprenorphine 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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Buprenorphine Diversion | 8 | 2 |
The 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).
| Ratio (US dollars/QALY) | O-BMT vs. Enhanced Referral |
|---|---|
| Incremental Cost-effectiveness Ratio (ICER) | -805067 |
The 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.
| years gained | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Quality-adjusted Life-years (QALYs) Gained | 0.20 (0.18 to 0.21) | 0.17 (0.15 to 0.19) |
Mean 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.
| US Dollars | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Mean Difference in Total Costs | 2702.43 (1280.77 to 6825.75) | 26853.97 (7001.37 to 146995.55) |
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.
| days | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Time to First Buprenorphine Prescription | 3.0 ± 4.6 | 14.0 ± 20.9 |
The 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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Number/Percentage of Participants Who Received Any Buprenorphine Prescription | 36 | 29 |
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.
| days | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Total Time Prescribed Buprenorphine | 46.7 ± 32.9 | 56.6 ± 34.8 |
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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Buprenorphine Adherence (Self-reported) | 13 | 13 |
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.
| Participants | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Buprenorphine Adherence (Confirmed) | 5 | 8 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| O-BMT (Onsite Treatment) | 0/48 (0%) | 1/48 (2.1%) | 2/48 (4.2%) |
| Enhanced Referral | 0/49 (0%) | 2/49 (4.1%) | 1/49 (2%) |
| Event | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Skin Infection (Abscess)Infections and infestations | 1/48 | 0/49 |
| Opioid OverdoseInjury, poisoning and procedural complications | 0/48 | 1/49 |
| Skin Infection (Methicillin-resistant Staphylococcus aureus)Infections and infestations | 0/48 | 1/49 |
| Event | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|
| Asthma AttackRespiratory, thoracic and mediastinal disorders | 1/48 | 1/49 |
| Endometriosis painInfections and infestations | 1/48 | 0/49 |
| Transportation AccidentInjury, poisoning and procedural complications | 0/48 | 1/49 |
| Age, Continuous(years) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Mean | 40.6 ± 9.9 | 43.3 ± 11.3 | 42.0 ± 10.6 |
| Sex/Gender, Customized(Participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Male | 38 | 38 | 76 |
| Female | 9 | 10 | 19 |
| Transgender | 0 | 1 | 1 |
| Refuse to answer | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Hispanic Black | 12 | 4 | 16 |
| Hispanic White | 5 | 4 | 9 |
| Hispanic Other | 13 | 14 | 27 |
| Non-Hispanic Black | 6 | 10 | 16 |
| Non-Hispanic White | 11 | 13 | 24 |
| Non-Hispanic Other | 1 | 4 | 5 |
| Region of Enrollment(participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| United States | 48 | 49 | 97 |
| Mental Health Condition(Participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Count of participants | 22 | 22 | 44 |
| Intravenous Drug Use(Participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Count of participants | 28 | 33 | 61 |
| Buprenorphine Use(Participants) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Count of participants | 19 | 16 | 35 |
| Opioid Use Disorder (OUD) Criteria(criteria) | O-BMT (Onsite Treatment) | Enhanced Referral | Total |
|---|---|---|---|
| Mean | 10.5 ± 2.1 | 10.8 ± 2.2 | 10.7 ± 2.2 |
7 further baseline measures are reported on the registry.
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