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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA055835 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).
The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth buprenorphine induction and maintenance | Experimental | Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine |
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| Standard in-person SL buprenorphine induction and maintenance | Active Comparator | In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine SL | Drug | Up to 24 mg per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to drop out | Comparing time to drop out between the treatment arms | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Brezing, MD | Contact | 646-774-6132 | cb3108@columbia.edu | |
| Elizabeth Martinez | Contact | 646-774-8181 |
| Name | Affiliation | Role |
|---|---|---|
| Christina Brezing, MD | New York State Psychiatric Institute | Principal Investigator |
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Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
beginning twelve months and ending 5 years after article publication
to researcher who provides a methodologically sound proposal to achieve aims in approved proposal
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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randomized, active-control, open-label
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| Telehealth | Other | Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session |
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| In-person treatment as usual | Other | in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. |
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