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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33DA057675-02 | U.S. NIH Grant/Contract | View source | |
| 1R61DA057675-01 | 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 trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RecoveryPad platform | Experimental | Participants randomized to RecoveryPad platform |
|
| Treatment as usual | No Intervention | Treatment as usual: referrals to harm reduction and other community resources that are already being given to individuals in the various community and healthcare settings from which these participants are being recruited. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RecoveryPad platform | Device | Telehealth platform to enhance motivation and engagement in treatment for OUD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance for MOUD | Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 30 days of enrollment. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance for MOUD | Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 31 to 90 days of enrollment. | Up to 90 days |
| Engagement with MOUD | Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebekah Heckmann, MD | Contact | (203) 737-8335 | rebekah.heckmann@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebekah Heckmann, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
In accordance with the HEAL Public Access and Data Sharing policy, de-identified IPD underlying the results reported in study-related publications will be shared. These will include participant-level data such as demographics/baseline characteristics, randomization results, and primary and secondary outcome measures.Direct identifiers will not be shared. Data will be de-identified using accepted standards.
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The de-identified IPD and relevant supporting documentation will be available no later than 12 months after completion of primary analyses and publication of the primary results, or within the period required by the HEAL Initiative data sharing policy. Data will remain available for a minimum of 3 years after the initial release date, subject to repository support and other policy requirements.
All shared data and associated supporting documentation will be uploaded to the National Addiction and Health Data Archive Program.
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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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| Up to 90 days |
| Overdose Events at 30 Days | A self-report of the number of subsequent overdose events within 30 days. | Up to 30 days |
| Overdose Events at 90 Days | A self-report of the number of subsequent overdose events within 90 days. | Up to 90 days |