Remote Observed Dosing of Suboxone to Improve Clinical Practice

NCT03769025 | Completed Phase 1 Results DMC

• 2 other identifiers: RODS5U34DA045177-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment of opiate dependence by prompting patients to take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug Administration (FDA) for the treatment of opiate dependence. All patients receive a smartphone and patients in the intervention (remote observed dosing) group will use the smartphone to take videos of themselves taking Suboxone.

Conditions

Opioid-use Disorder; Opioid Dependence; Opiate Dependence

Keywords

remote observed dosing

Outcome Measures

Primary Outcomes (1)

• Mean Urinary Buprenorphine Levels

  compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups

  12 weeks

Secondary Outcomes (1)

• Percent of Urine Positive Drug Screens

  12 weeks

Study Arms (2)

Remote Observed Dosing

EXPERIMENTAL

One group will be assigned to Remote Observed Dosing (ROD) and will have all of their Suboxone® doses remotely observed. The intervention is remote observed dosing

Behavioral: Suboxone Remote Observed Dosing

Attention Control

ACTIVE COMPARATOR

The attention control (AC) group will not have their dosing observed but will send a text message confirming they have taken their study medication to the study team daily matching contact with the study team. Text message confirming that they have taken their study medication is the intervention

Other: Suboxone Attention Control

Interventions

Suboxone Remote Observed Dosing BEHAVIORAL

The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day

Remote Observed Dosing

Suboxone Attention Control OTHER

Attention control group will send a text message daily confirming that they have taken their Suboxone dose

Attention Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily provide written informed consent prior to the conduct of any study-related procedure
• Male, female, or transgender
• years of age
• Meet DSM 5 criteria for opioid use disorder moderate to severe
• Women of childbearing potential must use a reliable means of contraception

You may not qualify if:

• Current diagnosis of AIDS
• Participation in buprenorphine maintenance treatment within the past 3 months
• Presence of AST and/or ALT equal to or \> 3X upper limit of normal
• Total bilirubin equal to or \> 1.5X upper limit of normal and/or estimated creatinine clearance \< 60ml/min
• Current diagnosis of pain requiring opioids
• Pregnant or lactating women
• Previous hypersensitivity or allergy to buprenorphine
• 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 - 5 criteria for current use disorder for any psychoactive substances other than opioids, marijuana, cocaine or nicotine (e.g. alcohol, sedatives)
• Current use of benzodiazepines
• 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
• Unwilling to accept or use alternative transportation (i.e. public transportation, taxi services, etc.) instead of driving self to appointments during Suboxone Induction
• Living in unstable housing

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This trial was intended to be a preliminary trial and involved a small number of subjects. Results should be interpreted accordingly.

Results Point of Contact

• Title: Kyle M Kampman MD Principal Investigator
• Organization: Perelman School of Medicine

kampman@pennmedicine.upenn.edu

215 746 2764

Study Officials

• Kyle Kampman, MD

  University of Pennsylvania

  STUDY DIRECTOR

• Brenda Curtis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 7, 2018
• Study Start: April 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: July 1, 2022
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)