Opioid-use Disorder Clinical Trial
Official title:
Pilot for Improved Office Based Treatment of Opioid-Dependence
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Be between the ages of 18 and 65 years old - Be able to provide informed consent - Be English-speaking - Have consistent phone and/or internet access - Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy - Maintained on a stable B/N dose Exclusion Criteria: - Be younger than 18 or older than 65 years of age - Chronic pain - Be non-English speaking - Be unable to complete informed consent - Be pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Friends Research Institute | Baltimore | Maryland |
United States | Artemis Institute for Clinical Research | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
MedicaSafe, Inc. | Friends Research Institute, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance - Week 4 | Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment. | Week 4 of the 12-week participation period. | |
Other | Compliance - Week 8 | Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment. | Week 8 of the 12-week participation period. | |
Primary | Compliance | Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment. | Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation. | |
Secondary | Urine Drug Screens | Urine Drug Tests will be given at each in-person study visit to test for opiates and other illicit substances. The proportion of negative urine samples (for opiates) will serve as a secondary endpoint. | Bi-weekly, across the 12-week participation period. | |
Secondary | Relapse | This will be determined by opiate-positive Urine Drug Screens. | Examined bi-weekly across the 12-week participation period. |
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