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Trial record 33 of 186 for:    BUPRENORPHINE AND NALOXONE

Rapid Initiation of Drug Treatment Engagement (RIDE)

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ClinicalTrials.gov Identifier: NCT03908437
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Prevention Point Philadelphia
Public Health Management Corporation
Philadelphia Department of Public Health
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Overdose Drug: buprenorphine/naloxone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Initiation of Buprenorphine/Naloxone to Optimize MAT Utilization in Philadelphia
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapid initiation
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management
Drug: buprenorphine/naloxone
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

Active Comparator: Treatment as usual
Seeking treatment from the BAC/CRC (treatment as usual)
Drug: buprenorphine/naloxone
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




Primary Outcome Measures :
  1. Confirmation of enrollment in ongoing medication assisted treatment at 1-month post-enrollment [ Time Frame: 1-month post-enrollment ]
    Engagement in ongoing medication assisted treatment at 1-month post-enrollment


Secondary Outcome Measures :
  1. Engagement in medication assisted treatment at 6-month post-enrollment [ Time Frame: 6-month follow-up ]
    Number of participants who are still engaged in medication assisted treatment

  2. Number of overdose between baseline and 6-month follow-up [ Time Frame: 6 months ]
    Report of the number of fatal and non-fatal overdoses

  3. Change in substance use from baseline to 6-month follow-up [ Time Frame: 6 months ]
    Evaluation of the change in substance use between baseline and 6-month follow-up assessed by the drug and alcohol section of the Addiction Severity Index and urine drug screen

  4. Economic value of the mobile intervention relative to treatment as usual [ Time Frame: Cost of 1-month intervention ]
    Cost evaluation of the mobile intervention using data collected with the DATCAP (Drug Abuse Treatment Cost Analysis Program) and NMOS (Non-Medical and Other Services)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908437


Contacts
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Contact: David S Metzger, PhD 215-746-7346 dsm@pennmedicine.upenn.edu
Contact: Cecile M Denis, PhD 215-746-0354 cdenis@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David S Metzger, PhD    215-746-7346    dsm@pennmedicine.upenn.edu   
Contact: Cecile M Denis, PhD    2157467352    cdenis@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Prevention Point Philadelphia
Public Health Management Corporation
Philadelphia Department of Public Health
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03908437     History of Changes
Other Study ID Numbers: R01CE003049 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
opiate use disorder
overdose
medication assisted treatment
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists