Remote Observed Dosing to Increase Suboxone Compliance
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/9/2017 |
| Start Date: | February 2013 |
| End Date: | September 2013 |
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy
of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate
dependence. To that end, 10 opiate dependent subjects will be recruited through the
University of Pennsylvania's Treatment Research Center, an outpatient substance abuse
treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted
as needed according to individual requirements).
of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate
dependence. To that end, 10 opiate dependent subjects will be recruited through the
University of Pennsylvania's Treatment Research Center, an outpatient substance abuse
treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted
as needed according to individual requirements).
Inclusion Criteria:
- Voluntarily provide written informed consent prior to the conduct of any study-related
procedure
- Male or female, 18 to 65 years of age,
- Meet DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of
contraception
- Owns a smartphone with forward facing camera that allows for use of Skype
Exclusion Criteria:
- University of Pennsylvania student, employee, or affiliate
- Current diagnosis of AIDS
- Presence of AST and/or ALT equal to or 3X upper limit of normal
- Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
- Current diagnosis of chronic pain requiring opioids
- Pregnant or lactating females
- Previous hypersensitivity or allergy to buprenorphine or EVA-containing substances
- 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-IV criteria for current dependence on any psychoactive substances other than
opioids or nicotine (e.g. alcohol, sedatives)
- Current use of benzodiazepines other than physician prescribed
- 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
- Participated in a clinical study within the previous 8 weeks
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