Remote Observed Dosing to Increase Suboxone Compliance

Opiate Dependence Clinical Trial

— RODISC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779973
• Other study ID #: 816651
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: November 3, 2017
• Start date: February 2013
• Est. completion date: September 2013

Study information

• Verified date: April 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Remote Observed Dosing

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patterns of missed doses including visit times and frequency impact.		9 months