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

NCT06532370 | Recruiting

• 2 other identifiers: RA-2024-019U54GM138062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contingency Managment; Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (1)

• TEA Outcomes at 6 and 12-weeks

  Treatment Effectiveness Assessment (TEA): This assessment asks individuals to respond to changes in four domains following a drug treatment program: substance use, health, lifestyle, and community. The score for each domain can range from 1 (no change or not much) to 10 (much better), for a total score of 4-40. This score allows for the prioritization of each participants values, and therefore does not require strict abstinence to demonstrate benefit from drug treatment.

  From enrollment to 6 and 12-weeks

Secondary Outcomes (1)

• Qualitative Outcomes

  At the end of treatment at 12-weeks

Other Outcomes (1)

• Urine Analysis Results

  From enrollment to the end of treatment at 12-weeks

Study Arms (1)

Contingency Managment

EXPERIMENTAL

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.

Behavioral: Contingency Managment

Interventions

Contingency Managment 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.

Contingency Managment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

The Queen's Medical Center

Honolulu, Hawaii, 90813, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 19345341 BACKGROUND

• 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.

  PMID: 33264267 BACKGROUND

• 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.

  PMID: 32555667 BACKGROUND

• 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.

  PMID: 31239805 BACKGROUND

Study Officials

• Todd Seto, MD

  The Queens Medical Center

  STUDY CHAIR

Central Study Contacts

Nicholas R Schumann, Clinical Psychologist

CONTACT

(808) 691-7024; nschumann@queens.org

Karen Ng, RN

CONTACT

808-691-4729; kng@queens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)