Clinical trial NCT01779973: Remote Observed Dosing to Increase Suboxone Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Keywords: Skype
compliance
remote dosing
suboxone
opiate
opiates
heroin
oxycontin
Philadelphia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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

Primary outcomes:
measure: The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study.
timeFrame: 9 months
Secondary outcomes:
measure: Patterns of missed doses including visit times and frequency impact.
timeFrame: 9 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jennifer G Plebani, PhD
role: PRINCIPAL_INVESTIGATOR
References: