Why Wait? Initiating Contingency Management in Traumatically Injured Patients During Hospitalization

This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients.

The goals are:

• Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma 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.
• To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants.
• To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital.

For total of 12 weeks, participants will:

• Be visited on Mondays/Thursdays or Tuesdays/Fridays by the research team to complete urine analysis during the hospitalization
• Visit a follow up clinic up to 2 times per week on Mondays/Thursdays or Tuesdays/Fridays to complete urinalysis following discharge from the hospital
• Complete Treatment Effectiveness Assessments at 6 and 12 weeks
• Engage in qualitative interview at the end of the CM program

Study Overview

• Status: Not yet recruiting
• Conditions: Contingency Management; Methamphetamine Use Disorder
• Intervention / Treatment: Behavioral: Contingency management

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miki Kiyokawa Addiction Medicine Physician, MD; Phone Number: 808-586-7425; Email: kiyokawa@hawaii.edu
• Study Contact Backup: Name: Nicholas Schumann R Clinical Psychologist; Phone Number: 808-691-7024; Email: nschumann@queens.org

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
      • Contact: Miki Kiyokawa Addiction Medicine Physician, MD; Phone Number: 808-586-7425; Email: kiyokawa@hawaii.edu
      • Contact: Nicholas Schumann R Clinical Psychologist; Phone Number: 808-691-7024; Email: nschumann@queens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Diagnostic and Statistical Manual of Mental Disorders 5th Edition, 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
• Expected discharge date within 45 days on the day of screening / recruitment

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
• Prisoners
• Individuals incarcerated at the time of their hospitalization
• Individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Contingency management intervention; Intervention is total of 12 weeks. During the hospitalization, participants will be visited by study personnel and will be asked to complete a urine drug screen that will screen for presence of methamphetamine on Mondays/Thursdays or Tuesdays/Fridays (M/Th or T/F). Once discharged, participants will be asked to come into the out patient clinic 2 times per week (M/Th or T/F) to complete a urine drug screen that will screen for presence of methamphetamine. If the specimen is negative for methamphetamine, the participants will be rewarded. Participants will also be asked to complete the Treatment Effectiveness Assessment (TEA) with study personnel.

Behavioral: Contingency management; If the urine sample is 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 50% of the slips offer written praises (i.e. "great job!"). The other 50% of slips are the divided between low value (i.e. food gift cards, bus passes), medium value (i.e. prepaid cellphone, clothing gift cards), and a few large value rewards (i.e. electronic tablet, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment	TEA (Treatment Effectiveness Assessment) at 6- and 12-weeks post-enrollment to assess both patient-reported medium-term program effectiveness. TEA 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conduct qualitative interviews with participants post-program	Interviews will be conducted as semi-structured qualitative interviews with participants post-program and will be transcribed and analyzed using a Template Analysis approach. Coders will conduct coding of the interview data to ultimately identify themes that will be used as the basis for interpretation. The final analysis of the qualitative data will include contrasts and comparisons made across interviews to examine overlaps and divergences across any relevant sub-samples (i.e. sex, age). Results will present thematic patterns, how frequently each code occurs, and any contradictory evidence. This will allow for the identification of common themes and perspectives, which will provide necessary cultural insights and possible adaptations for further implementation efforts.	At the end of the treatment at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of rate of AMA and treatment completion in acute hospital setting in participants	To assess the rate of AMA and treatment completion in acute hospital setting in participants To assess the optimal timing of CM initiation for trauma injury hospitalized patients by comparing patient outcomes to the Schumann's pilot project 2024 (7/2024-6/2025) (NCT06532370 - Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii). We will compare the duration of CM participation and the rates of CM program completion and providing negative urine samples.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Queen's Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Contingency management; Methamphetamine Use Disorder; Contingency management during acute hospitalization; Contingency management in Trauma Injured Patients
• Other Study ID Numbers: RA-2025-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No