Trial · NCT03150173
Onsite Buprenorphine Treatment at Syringe Exchange Programs
NCT03150173, Phase 2, Completed, Montefiore Medical Center; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Onsite Buprenorphine Treatment at Syringe Exchange Programs. Trials, record NCT03150173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03150173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Onsite Buprenorphine Treatment at Syringe Exchange Programs
- NCT number
- NCT03150173
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Opiate Addiction
- Interventions
- Onsite treatment, Enhanced referral, Buprenorphine
- First posted
- 2017-05-12
- Last updated
- 2025-12-11
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Buprenorphine Engagement | 30 days after randomization | 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. |
| Secondary | Treatment Retention | 6 months | 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. |
| Secondary | HIV Risk Behaviors | 6 months | 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. |
| Secondary | Buprenorphine Diversion | 6 months | 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. |
| Secondary | Incremental Cost-effectiveness Ratio (ICER) | 6 months | 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). |
| Secondary | Quality-adjusted Life-years (QALYs) Gained | 6 months | 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. |
| Secondary | Mean Difference in Total Costs | 6 months | 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. |
| Secondary | Time to First Buprenorphine Prescription | 1 month | 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. |
| Secondary | Number/Percentage of Participants Who Received Any Buprenorphine Prescription | 6 months | 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. |
| Secondary | Total Time Prescribed Buprenorphine | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Buprenorphine Engagement | 30 days after randomization | Intention to treat (ITT) analysis design. All participants, including those who are lost to follow-up, are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Retention | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | HIV Risk Behaviors | 6 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Buprenorphine Diversion | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incremental Cost-effectiveness Ratio (ICER) | 6 months | Ratio (US dollars/QALY) | NUMBER | |
| SECONDARY | Quality-adjusted Life-years (QALYs) Gained | 6 months | years gained | MEAN | |
| SECONDARY | Mean Difference in Total Costs | 6 months | US Dollars | LEAST_SQUARES_MEAN | |
| SECONDARY | Time to First Buprenorphine Prescription | 1 month | Time to first buprenorphine prescription results data was only available, and reported, from the sub-group of participants that received a prescription. | days | MEAN |
| SECONDARY | Number/Percentage of Participants Who Received Any Buprenorphine Prescription | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Time Prescribed Buprenorphine | 6 months | Total time prescribed buprenorphine results data was only available, and reported, from the sub-group of participants that received a prescription. | days | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Buprenorphine Engagement | O-BMT (Onsite Treatment) | 19 | Participants | ||
| Buprenorphine Engagement | Enhanced Referral | 19 | Participants | ||
| Treatment Retention | O-BMT (Onsite Treatment) | 2 | Participants | ||
| Treatment Retention | Enhanced Referral | 6 | Participants | ||
| HIV Risk Behaviors | O-BMT (Onsite Treatment) | 5 | Participants | ||
| HIV Risk Behaviors | Enhanced Referral | 4 | Participants | ||
| Buprenorphine Diversion | O-BMT (Onsite Treatment) | 8 | Participants | ||
| Buprenorphine Diversion | Enhanced Referral | 2 | Participants | ||
| Incremental Cost-effectiveness Ratio (ICER) | O-BMT vs. Enhanced Referral | -805067 | Ratio (US dollars/QALY) | ||
| Quality-adjusted Life-years (QALYs) Gained | O-BMT (Onsite Treatment) | 0.20 | 95% Confidence Interval 0.18 to 0.21 | years gained |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | O-BMT (Onsite Treatment) | 48 | |
| Overall Study | STARTED | Enhanced Referral | 49 | |
| Overall Study | COMPLETED | O-BMT (Onsite Treatment) | 35 | |
| Overall Study | COMPLETED | Enhanced Referral | 44 | |
| Overall Study | NOT COMPLETED | O-BMT (Onsite Treatment) | 13 | |
| Overall Study | NOT COMPLETED | Enhanced Referral | 5 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthma Attack | Respiratory, thoracic and mediastinal disorders | O-BMT (Onsite Treatment) | 1 | 48 | |
| other | Asthma Attack | Respiratory, thoracic and mediastinal disorders | Enhanced Referral | 1 | 49 | |
| other | Transportation Accident | Injury, poisoning and procedural complications | O-BMT (Onsite Treatment) | 0 | 48 | |
| other | Transportation Accident | Injury, poisoning and procedural complications | Enhanced Referral | 1 | 49 | |
| other | Endometriosis pain | Infections and infestations | O-BMT (Onsite Treatment) | 1 | 48 | |
| other | Endometriosis pain | Infections and infestations | Enhanced Referral | 0 | 49 | |
| serious | Opioid Overdose | Injury, poisoning and procedural complications | O-BMT (Onsite Treatment) | 0 | 48 | 0 |
| serious | Opioid Overdose | Injury, poisoning and procedural complications | Enhanced Referral | 1 | 49 | 1 |
| serious | Skin Infection (Abscess) | Infections and infestations | O-BMT (Onsite Treatment) | 1 | 48 | 1 |
| serious | Skin Infection (Abscess) | Infections and infestations | Enhanced Referral | 0 | 49 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | O-BMT (Onsite Treatment) | 0 | 48 |
| Total, all-cause mortality | Enhanced Referral | 0 | 49 |
| Total, other adverse events | O-BMT (Onsite Treatment) | 2 | 48 |
| Total, other adverse events | Enhanced Referral | 1 | 49 |
| Total, serious adverse events | O-BMT (Onsite Treatment) | 1 | 48 |
| Total, serious adverse events | Enhanced Referral | 2 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34990854 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA044878 | Buprenorphine treatment at syringe exchanges to reduce opioid misuse and HIV risk | FOX, AARON D | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL INSTITUTE ON DRUG ABUSE | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| O-BMT (Onsite Treatment) vs Enhanced Referral: Buprenorphine Diversion | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: Buprenorphine Engagement | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: Number/Percentage of Participants Who Received Any Buprenorphine Prescription | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: HIV Risk Behaviors | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: Buprenorphine Adherence (Confirmed) | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: Treatment Retention | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: deaths from any cause | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: Buprenorphine Adherence (Self-reported) | Trial comparisons |
| O-BMT (Onsite Treatment) vs Enhanced Referral: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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