Clinical trial NCT06532370: Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii
Official title: Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contingency Managment
Methamphetamine Use Disorder
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: TEA Outcomes at 6 and 12-weeks
timeFrame: From enrollment to 6 and 12-weeks
Secondary outcomes:
measure: Qualitative Outcomes
timeFrame: At the end of treatment at 12-weeks
Other outcomes:
measure: Urine Analysis Results
timeFrame: From enrollment to the end of treatment at 12-weeks
Locations:
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
Study officials:
affiliation: The Queens Medical Center
name: Todd Seto, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.