Opiate Dependence
Conditions
Keywords
Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin, Philadelphia
Brief summary
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).
Interventions
BEHAVIORALRemote Observed Dosing
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Patterns of missed doses including visit times and frequency impact. | 9 months |
Countries
United States
Outcome results
None listed