NCT04585399

Brief Summary

The increased prevalence of opioid use disorder (OUD) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ED). Thus, the ED may be an ideal location for identifying patients in need of OUD treatment and can serve as the first touch point in the OUD continuum of care to promote medication assisted treatment initiation. Contingency management (CM) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. The primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering CM to increase combined buprenorphine + nalaxone (referred to as BUP hereafter) initiation and continuous adherence for OUD in an existing ED "bridge" program (e.g., Bridge plus CM; B+CM) relative to standard care. Secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 4, 2025

Status Verified

February 1, 2025

Enrollment Period

4.8 years

First QC Date

March 9, 2020

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Attendance at first scheduled clinic appointment

    We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED

    1 week

  • Percentage of sessions where buprenorphine positive urine results was recorded

    Urine-verified buprenorphine

    3-months

  • Percentage of sessions where opioid free urine results were recorded

    Urine-verified opioid abstinence

    3-months

  • Treatment acceptability

    Participants will evaluate the treatment at the end.

    3-months

Secondary Outcomes (4)

  • Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results

    3-months

  • Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results

    3-months

  • Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results

    3-months

  • Neurological Soft Signs correlate with treatment success

    3-months

Study Arms (2)

Contingency Management

EXPERIMENTAL

Participants in this arm of the study will receive financial incentives for attending their buprenorphine appointments and for being clean from other opioids. Participants in this group will also have up to two rides per week paid for to attend bup appointments.

Behavioral: Contingency management

Standard Care

NO INTERVENTION

Participants in this group will be treatment as usual and will not receive any incentives for attending their bup appointments or for being opioid abstinent.

Interventions

Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.

Contingency Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants at least 18 years of age
  • Participants must be newly enrolled in the Bridge program in the Cooper University ED, with their first clinic appointment scheduled to take place at the Cooper Outreach Clinic within one week of enrollment.
  • All subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy

You may not qualify if:

  • Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
  • Participants who are currently pregnant or breastfeeding or have been diagnosed with a DSM-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia)
  • Participants who are non-English speaking or cannot otherwise provide valid informed consent.
  • Individuals who are unable to complete the survey assessments, due to literacy or visual impairments.
  • The participant will not be a prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08108, United States

Location

Related Publications (1)

  • Goodwin SR, Kirby KC, Salzman MS, Raiff BR. Pragmatic and low-cost contingency management intervention increases buprenorphine treatment engagement: Randomized controlled trial. Exp Clin Psychopharmacol. 2026 Feb;34(1):68-77. doi: 10.1037/pha0000823.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants will only told if they are assigned to the contingency management group because there are different procedures for those individuals. The care providers will not know which participants are in the control group but they may know when people are in the CM group because extra urine screens will be collected and they will be scheduled for rides.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

October 14, 2020

Study Start

January 27, 2020

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

April 4, 2025

Record last verified: 2025-02

Locations