Remote Observed Dosing of Suboxone to Improve Clinical Practice
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/5/2019 |
| Start Date: | April 1, 2019 |
| End Date: | December 2022 |
| Contact: | Katherine Crockett |
| Email: | kcrock@pennmedicine.upenn.edu |
| Phone: | 215-746-1990 |
This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance
in opiate dependent subjects.The main purpose of this study is to see if watching patients
take their medication will improve treatment of opiate dependence by prompting patients to
take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug
Administration (FDA) for the treatment of opiate dependence. All patients receive a
smartphone and patients in the intervention (remote observed dosing) group will use the
smartphone to take videos of themselves taking Suboxone.
in opiate dependent subjects.The main purpose of this study is to see if watching patients
take their medication will improve treatment of opiate dependence by prompting patients to
take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug
Administration (FDA) for the treatment of opiate dependence. All patients receive a
smartphone and patients in the intervention (remote observed dosing) group will use the
smartphone to take videos of themselves taking Suboxone.
Inclusion Criteria:
- Voluntarily provide written informed consent prior to the conduct of any study-related
procedure
- Male, female, or transgender
- 18 - 45 years of age
- Meet DSM 5 criteria for opioid use disorder moderate to severe
- Women of childbearing potential must use a reliable means of contraception
Exclusion Criteria:
- Current diagnosis of AIDS
- Participation in buprenorphine maintenance treatment within the past 3 months
- Presence of AST and/or ALT equal to or > 3X upper limit of normal
- Total bilirubin equal to or > 1.5X upper limit of normal and/or estimated creatinine
clearance < 60ml/min
- Current diagnosis of pain requiring opioids
- Pregnant or lactating women
- Previous hypersensitivity or allergy to buprenorphine
- Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g.
ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors
(e.g. ritonavir, indinavir, saquinavir)
- Meet DSM - 5 criteria for current use disorder for any psychoactive substances other
than opioids, marijuana, cocaine or nicotine (e.g. alcohol, sedatives)
- Current use of benzodiazepines
- Significant medical or psychiatric symptoms or dementia which in the opinion of the
investigators would preclude compliance with the protocol, adequate cooperation in the
study, or obtaining informed consent
- Concurrent medical conditions (such as severe respiratory insufficiency) that may
prevent the patient from safely participating in the study; and/or any pending legal
action that could prohibit participation and/or compliance in study procedures
- Unwilling to accept or use alternative transportation (i.e. public transportation,
taxi services, etc.) instead of driving self to appointments during Suboxone Induction
- Living in unstable housing
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