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Remote Observed Dosing to Increase Suboxone Compliance

NCT ID: NCT01779973

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Opiate Dependence

Keywords

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Skype compliance remote dosing suboxone opiate opiates heroin oxycontin Philadelphia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Remote Observed Dosing

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

Group Type EXPERIMENTAL

Remote Observed Dosing

Intervention Type BEHAVIORAL

Interventions

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Remote Observed Dosing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer G Plebani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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816651

Identifier Type: -

Identifier Source: org_study_id