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

Not Applicable

Not yet recruiting

• Conditions: Contingency Management; Methamphetamine Use Disorder

• Registration Number: NCT06931197
• Lead Sponsor: Queen's Medical Center

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, Wednesdays and Fridays by the research team to complete urine analysis during the hospitalization

* Visit a follow up clinic up to 3 times per week on Mondays, Wednesdays and 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Study Start: 2025-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment	From enrollment to 6 and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Conduct qualitative interviews with participants post-program	At the end of the treatment at 12 weeks	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.

Trial Locations

Locations (1)

The Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States