Remote Observed Dosing to Increase Suboxone Compliance
Completed · Not applicable
Conditions studied: Opiate Dependence
In brief
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).
Key facts
- Study ID
- NCT01779973
- Run by
- University of Pennsylvania
- People needed
- 9
- Starts
- 2013-02-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2017-11-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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