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Remote Observed Dosing to Increase Suboxone Compliance (RODISC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779973
First Posted: January 30, 2013
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
  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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research

Further study details as provided by Jennifer Plebani, 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 ]

Secondary Outcome Measures:
  • Patterns of missed doses including visit times and frequency impact. [ Time Frame: 9 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jennifer Plebani, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01779973     History of Changes
Other Study ID Numbers: 816651
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: April 3, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists