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Completed

NCT Number: NCT01779973

Remote Observed Dosing to Increase Suboxone Compliance

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).

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Key information

Conditions

Opiate Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Observed Dosing

Behavioral

Primary outcomes

  1. 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 outcomes

  1. Patterns of missed doses including visit times and frequency impact.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: RODISC

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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