NCT01779973

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 7, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

January 28, 2013

Last Update Submit

November 3, 2017

Conditions

Opiate Dependence

Keywords

Skypecomplianceremote dosingsuboxoneopiateopiatesheroinoxycontinPhiladelphia

Outcome Measures

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.

    9 months

Secondary Outcomes (1)

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

    9 months

Study Arms (1)

Remote Observed Dosing

EXPERIMENTAL

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

Interventions

Remote Observed DosingBEHAVIORAL
Remote Observed Dosing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersPatient Compliance

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jennifer G Plebani, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 7, 2017

Record last verified: 2017-04

Locations

US(1)