Remote Observed Dosing to Increase Suboxone Compliance | NCT01779973

Studies
Remote Observed Dosing to Increase Suboxone Compliance

NCT01779973

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Nov 7, 2017Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Opiate Dependence

Interventions

Remote Observed Dosing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2017

Last Update Posted Date

Nov 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Remote Observed Dosing	Behavioral		Remote Observed Dosing

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patterns of missed doses including visit times and frequency impact.		9 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009293	Opioid-Related Disorders
D010349	Patient Compliance

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders