Remote Observed Dosing to Increase Suboxone Compliance (RODISC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01779973
First received: January 28, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Opiate Dependence
Behavioral: Remote Observed Dosing
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The number of suboxone dose taken during the course of the study. The number of opiate-negative urine samples provided during the study. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of missed doses including visit times and frequency impact. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Observed Dosing
Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit.
Behavioral: Remote Observed Dosing

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779973

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jennifer G Plebani, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jennifer Plebani, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01779973     History of Changes
Other Study ID Numbers: 816651
Study First Received: January 28, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Skype
compliance
remote dosing
suboxone
opiate
opiates
heroin
oxycontin
Philadelphia

ClinicalTrials.gov processed this record on October 19, 2014