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Onsite Buprenorphine Treatment at Syringe Exchange Programs
Phase 2 trial testing Onsite treatment in Opiate Addiction in 97 participants. Completed in 31 March 2024.
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 2 January 2019 |
| Primary completion | 11 October 2023 |
| Estimated completion | 31 March 2024 |
| Sites | 3 locations across United States |
Montefiore Medical Center
18 and older, any sex, with Opiate Addiction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 19 | |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 2 | |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 5 | |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 8 | |
| Enhanced Referral | 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).
| Group | Value | 95% CI |
|---|---|---|
| O-BMT vs. Enhanced Referral | -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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 0.20 | 0.18 – 0.21 |
| Enhanced Referral | 0.17 | 0.15 – 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 2702.43 | 1280.77 – 6825.75 |
| Enhanced Referral | 26853.97 | 7001.37 – 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 3.0 | ± 4.6 |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 36 | |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 46.7 | ± 32.9 |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 13 | |
| Enhanced Referral | 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.
| Group | Value | 95% CI |
|---|---|---|
| O-BMT (Onsite Treatment) | 5 | |
| Enhanced Referral | 8 |
Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|---|
| Opioid Overdose | Injury, poisoning and procedural complications | — | — |
| Skin Infection (Abscess) | Infections and infestations | — | — |
| Skin Infection (Methicillin-resistant Staphylococcus aureus) | Infections and infestations | — | — |
| Reaction | System | O-BMT (Onsite Treatment) | Enhanced Referral |
|---|---|---|---|
| Asthma Attack | Respiratory, thoracic and mediastinal disorders | — | — |
| Transportation Accident | Injury, poisoning and procedural complications | — | — |
| Endometriosis pain | Infections and infestations | — | — |
Most-reported serious reactions: Opioid Overdose, Skin Infection (Abscess), Skin Infection (Methicillin-resistant Staphylococcus aureus).
Data from ClinicalTrials.gov NCT03150173 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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