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Behavioral Intervention
Trauma-Informed Intervention for Substance Use Disorders (TRUST Trial)
Fredonia, KY
N/A
Waitlist Available
Led By Michele Staton, MSW, PhD
Research Sponsored by Michele Staton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 3 and 6 months post-release from prison
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to reduce the risk of overdose for women involved in the criminal legal system as they reintegrate into the community. They will be testing a new intervention called Trust-Based Relational Intervention (TB
See full description
Who is the study for?
This trial is for women with substance use disorders who are transitioning back into the community from the criminal legal system. It's designed to help them reduce their risk of overdose by using a new approach that considers their past trauma.
What is being tested?
The study tests an intervention called Trust-Based Relational Intervention (TBRI) combined with Treatment as Usual (TAU) and additional re-entry recovery support, against TBRI alone or just TAU. The goal is to see which method best reduces substance use and supports transition.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort when addressing traumatic experiences during therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 3 and 6 months post-release from prison
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 3 and 6 months post-release from prison
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in overdose risk
Secondary study objectives
Change in trauma-related symptoms
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TBRI aloneExperimental Treatment1 Intervention
Treatment as usual and the adapted version of TBRI for adult women
Group II: Re-entry Recovery SupportExperimental Treatment1 Intervention
Treatment as usual, the adapted TBRI, and on-going re-entry recovery support with the Safe Support Person (SPP).
Group III: Treatment As Usual (TAU)Active Control1 Intervention
Traditional in-prison SUD treatment
Find a Location
Closest Location:Kentucky Correctional Institution for Women· Pewee Valley, KY· 176 miles
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,890 Previous Clinical Trials
8,050,436 Total Patients Enrolled
Michele StatonLead Sponsor
4 Previous Clinical Trials
1,369 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,651 Previous Clinical Trials
3,408,470 Total Patients Enrolled
Michele Staton, MSW, PhDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
900 Total Patients Enrolled
Kevin Knight, PhDPrincipal InvestigatorTexas Christian University