Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii

NCT ID: NCT06532370

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-09-30

Brief Summary

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The goal of this clinical trial is to use contingency management (CM) as an intervention tool to address methamphetamine use.

The main objectives are to:

* Gather effectiveness data on a pilot a CM program for participants in Hawaii who use methamphetamine following hospitalization due to traumatic injury
* To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program.

Participants will:

* Visit a follow-up clinic up to three times per week to complete urinalysis following discharge from the trauma unit
* Complete Treatment Effectiveness Assessments at 6 and 12-weeks
* Engage in a qualitative interview at the end of the CM program

Detailed Description

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Conditions

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Contingency Managment Methamphetamine Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will all be assigned to the CM intervention group and will be asked to follow-up three times per week for a total of 12-weeks to engage in the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Contingency Managment

Participants are allowed to complete CM three times per week for the maximum of 12-weeks. At the six- and 12-week time points, participants will complete the Treatment Effectiveness Assessment (TEA) with study personnel.

Group Type EXPERIMENTAL

Contingency Managment

Intervention Type BEHAVIORAL

If the sample be methamphetamine negative, participant will be positively reinforced and offered incentives. Participants immediately draw the reinforcement slip of paper to receive a prize from a selection kept on-site. Approximately, half of the slips offer written praise (e.g. "great job!"). The other half of slips are then divided between low value (e.g. food gift cards, bus passes), medium value (e.g. prepaid cell phone, clothing gift cards), and a few large value rewards (e.g. iPad, jewelry). Should the sample be positive for methamphetamine, no reinforcement and/or incentive to be provided. Participant will be encouraged to continue to participate in CM program and follow-up on the next CM date.

Interventions

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Contingency Managment

If the sample be methamphetamine negative, participant will be positively reinforced and offered incentives. Participants immediately draw the reinforcement slip of paper to receive a prize from a selection kept on-site. Approximately, half of the slips offer written praise (e.g. "great job!"). The other half of slips are then divided between low value (e.g. food gift cards, bus passes), medium value (e.g. prepaid cell phone, clothing gift cards), and a few large value rewards (e.g. iPad, jewelry). Should the sample be positive for methamphetamine, no reinforcement and/or incentive to be provided. Participant will be encouraged to continue to participate in CM program and follow-up on the next CM date.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Admitted trauma patients
* Age greater than 18 years old
* Urine drug screen positive for methamphetamines during the current hospitalization
* Report at least weekly methamphetamine use
* First methamphetamine use greater than 6 months prior to injury
* Report at least 4 DSM-V Amphetamine-Type Substance Use Disorder symptoms (at least moderate disease)
* Glasgow Coma Scale ≥13 upon arrival to the emergency department
* Ability to understand and participate in study procedures
* Ability to communicate in English

Exclusion Criteria

* Active psychosis (reporting auditory or visual hallucinations)
* Under ongoing cardiorespiratory monitoring
* Evidence of moderate or severe traumatic brain injury
* Patients who are known to be pregnant
* Prisoner
* Individuals incarcerated at the time of their hospitalization
* Individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Queen's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Seto, MD

Role: STUDY_CHAIR

The Queens Medical Center

Locations

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The Queen's Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicholas R Schumann, Clinical Psychologist

Role: CONTACT

(808) 691-7024

Karen Ng, RN

Role: CONTACT

808-691-4729

Facility Contacts

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Nicholas Schumann

Role: primary

808-691-7024

References

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Gold MS, Kobeissy FH, Wang KK, Merlo LJ, Bruijnzeel AW, Krasnova IN, Cadet JL. Methamphetamine- and trauma-induced brain injuries: comparative cellular and molecular neurobiological substrates. Biol Psychiatry. 2009 Jul 15;66(2):118-27. doi: 10.1016/j.biopsych.2009.02.021. Epub 2009 Apr 5.

Reference Type BACKGROUND
PMID: 19345341 (View on PubMed)

El Moheb M, Herrera-Escobar JP, Breen K, Orlas C, Haynes AN, Levy-Carrick NC, Nehra D, Sanchez SE, Salim A, Velmahos G, Kaafarani HMA. Long-term outcomes of psychoactive drug use in trauma patients: A multicenter patient-reported outcomes study. J Trauma Acute Care Surg. 2021 Feb 1;90(2):319-324. doi: 10.1097/TA.0000000000003032.

Reference Type BACKGROUND
PMID: 33264267 (View on PubMed)

Ronsley C, Nolan S, Knight R, Hayashi K, Klimas J, Walley A, Wood E, Fairbairn N. Treatment of stimulant use disorder: A systematic review of reviews. PLoS One. 2020 Jun 18;15(6):e0234809. doi: 10.1371/journal.pone.0234809. eCollection 2020.

Reference Type BACKGROUND
PMID: 32555667 (View on PubMed)

Ling W, Nadipelli VR, Solem CT, Farabee D, Ronquest NA, Perrochet B, Learned SM, Deshpande CG, Heidbreder C. Measuring recovery in opioid use disorder: clinical utility and psychometric properties of the Treatment Effectiveness Assessment. Subst Abuse Rehabil. 2019 Jun 5;10:13-21. doi: 10.2147/SAR.S198361. eCollection 2019.

Reference Type BACKGROUND
PMID: 31239805 (View on PubMed)

Other Identifiers

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U54GM138062

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RA-2024-019

Identifier Type: -

Identifier Source: org_study_id

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