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

NCT06931197 | Not Yet Recruiting

• 1 other identifier: RA-2025-012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contingency Management; Methamphetamine Use Disorder

Keywords

Contingency management; Methamphetamine Use Disorder; Contingency management during acute hospitalization; Contingency management in Trauma Injured Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Conduct qualitative interviews with participants post-program

  At the end of the treatment at 12 weeks

Other Outcomes (1)

• Assessment of rate of AMA and treatment completion in acute hospital setting in participants

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Contingency management intervention

EXPERIMENTAL

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

Interventions

Contingency management BEHAVIORAL

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.

Contingency management intervention

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 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

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
• 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

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (1)

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Central Study Contacts

Miki Kiyokawa Addiction Medicine Physician, MD

CONTACT

808-586-7425; kiyokawa@hawaii.edu

Nicholas Schumann R Clinical Psychologist

CONTACT

808-691-7024; nschumann@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 be assigned to the CM intervention group and for the total of 12 weeks, he/she will be followed up two times a week during the hospitalization and up to three times per week as an outpatient to engage in intervention.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)