Opioid-use DisorderNCT04585399
Increasing MAT Engagement With Financial Incentives
A study testing Contingency management in people with Opioid-use Disorder, run by Rowan University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08108
About this study
Official title: Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program
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.
- Conditions
- Opioid-use Disorder
- Being tested
- Contingency management
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at first scheduled clinic appointment
We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED
Measured: 1 week
Percentage of sessions where buprenorphine positive urine results was recorded
Urine-verified buprenorphine
Measured: 3-months
Percentage of sessions where opioid free urine results were recorded
Urine-verified opioid abstinence
Measured: 3-months
Treatment acceptability
Participants will evaluate the treatment at the end.
Measured: 3-months
Secondary outcomes (4)
Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results
Delay discounting will be evaluated, using the brief, five question delay discounting procedure and will be correlated with urine results determining opioid abstinence and buprenorphine adherence.
Measured: 3-months
Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results
The opioid purchasing task will be used to evaluate opioid demand and will be correlated with urine results determining opioid abstinence and buprenorphine adherence.
Measured: 3-months
Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results
A modified Pleasant Events Scale survey will be used to evaluate access to, and enjoyment from, substance-free activities and the results will be correlated with urine results determining opioid abstinence and buprenorphine adherence.
Measured: 3-months
Neurological Soft Signs correlate with treatment success
Participants will complete a drawing task that has been correlated with other substance use treatment outcomes in the past.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start27 Jan 2020
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group, randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Cooper Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585399
- Sponsor's protocol ID
- 19-112EX
- Status last verified
- Feb 2025
- First submitted
- 9 Mar 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share the data after we have completed the study and have published all of the outcomes. We will only share the data with qualified researchers who provide a written request with clear justification for their need to access the data.
Publications
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.
PubMed 41538228
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program
- ClinicalTrials.gov ID
- NCT04585399
- Acronym / sponsor ID
- 19-112EX
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- The Cooper Health System
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency managementParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementFinancial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week. | Behavioural | Contingency Management |
Primary outcome
Attendance at first scheduled clinic appointment
Time frame: 1 week
We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED
Percentage of sessions where buprenorphine positive urine results was recorded
Time frame: 3-months
Urine-verified buprenorphine
Percentage of sessions where opioid free urine results were recorded
Time frame: 3-months
Urine-verified opioid abstinence
Treatment acceptability
Time frame: 3-months
Participants will evaluate the treatment at the end.
4 secondary outcomes
Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results
Time frame: 3-months
Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results
Time frame: 3-months
Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results
Time frame: 3-months
Neurological Soft Signs correlate with treatment success
Time frame: 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 41538228Goodwin 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.
- Individual participant dataSharing planned: Undecided. We will share the data after we have completed the study and have published all of the outcomes. We will only share the data with qualified researchers who provide a written request with clear justification for their need to access the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Opioid-use Disorder, run by Rowan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at first scheduled clinic appointment (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.