Rapid Initiation of Drug Treatment Engagement

NCT03908437 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: R01CE003049
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recruitment will take place in two targeted neighborhoods of Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and non-fatal opioid overdose. A total of 250 participants will be engaged in the research. Following informed consent and determination of eligibility, 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall Mercer Community Mental Health (serving South Philadelphia). The intervention group will receive four weeks of treatment with buprenorphine /naloxone and support for treatment engagement provided by a case manager and a peer recovery specialist. All participants will be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint for the study is continued enrollment in medication-assisted treatment at 6-month post-enrollment. The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. The specific aims are:

• Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment.
• Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment.
• Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.

Conditions

Opioid-use Disorder; Overdose

Keywords

opiate use disorder; overdose; medication assisted treatment

Outcome Measures

Primary Outcomes (1)

• Enrollment in Medication Assisted Treatment at 1-month Post-enrollment

  Number of participants receiving treatment with medication for opioid use disorder at 1-month post-enrollment

  1-month post-enrollment

Secondary Outcomes (4)

• Enrollment in Medication Assisted Treatment at 6-month Post-enrollment

  6-month follow-up

• Overdose During the 6-month Follow-up

  6 months

• Change in Opioid Use From Baseline to 6-month Follow-up

  6 months

• Economic Value of the Mobile Intervention Relative to Treatment as Usual

  Cost of 1-month intervention --- could not address this outcome

Study Arms (2)

Rapid initiation

EXPERIMENTAL

Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management

Drug: buprenorphine/naloxone

Treatment as usual

ACTIVE COMPARATOR

Seeking treatment from the BAC/CRC (treatment as usual)

Drug: buprenorphine/naloxone

Interventions

buprenorphine/naloxone DRUG

A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager. The team will rapidly confirm opioid use disorder and risk of overdose, complete informed consent, and begin induction procedures for a "transitional" (one month) course of buprenorphine/naloxone treatment. During this time, the dedicated case manager and PRS will work with the participants to help them become engaged in existing medication assisted treatment programs

Rapid initiation; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years of age or older
• Opioid overdose in the prior 12 months
• Meet criteria for opioid use disorder
• Resident of Philadelphia
• Willingness and ability to participate in study procedures

You may not qualify if:

• Inability to comprehend or complete study procedures
• Plans to relocate during study time frame
• Currently in medication assisted treatment (MAT) for substance use disorder
• Evidence of serious liver disease (LFTs \> 3 x the upper limit of normal)
• Pregnancy or lactation
• Moderate to severe alcohol or benzodiazepine use disorder

Sponsors & Collaborators

• University of Pennsylvania: lead
• Prevention Point Philadelphia: collaborator
• Public Health Management Corporation: collaborator
• Philadelphia Department of Public Health: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Drug Overdose

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Metzger, Research Professor, Director of HIV Prevention Research Unit
• Organization: University of Pennsylvania, Dpt of Psychiatry, Perelman School of Medicine

dsm@pennmedicine.upenn.edu

215-746-7355

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 9, 2019
• Study Start: July 15, 2019
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 3, 2024
• Results First Posted: May 6, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)