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Remote Observed Dosing to Increase Suboxone Compliance (RODISC)

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Observed Dosing
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opiate Dependence focused on measuring Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin, Philadelphia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote Observed Dosing

Arm Description

Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit.

Outcomes

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.

Secondary Outcome Measures

Patterns of missed doses including visit times and frequency impact.

Full Information

First Posted
January 28, 2013
Last Updated
November 3, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01779973
Brief Title
Remote Observed Dosing to Increase Suboxone Compliance
Acronym
RODISC
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Skype, compliance, remote dosing, suboxone, opiate, opiates, heroin, oxycontin, Philadelphia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Observed Dosing
Arm Type
Experimental
Arm Description
Compliance with dosage observations of suboxone doses using remote observed dosing 4 days per week and 1 weekly in-office visit.
Intervention Type
Behavioral
Intervention Name(s)
Remote Observed Dosing
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patterns of missed doses including visit times and frequency impact.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer G Plebani, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Remote Observed Dosing to Increase Suboxone Compliance

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