Substance Use Disorder (SUD)TRUSTNCT06651528
Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition
A study testing TAU + TRUST, TAU + TRUST + Re-entry Recovery Support and Treatment as Usual (TAU) in people with Substance Use Disorder (SUD), run by Michele Staton at 4 sites in United States.
Trial summary
The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- TAU + TRUST, TAU + TRUST + Re-entry Recovery Support and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Dec 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participating in corrections-based SUD treatment
- have an anticipated parole eligibility date within 4 months
- self-identified history of violent victimization
- are willing to work with at least one person living in the community who will be supportive of your recovery when you get out
- interested in participating in the study
Who cannot join
- not participating in corrections-based SUD treatment
- anticipated parole eligibility date greater than 4 months
- no self-identified history of violent victimization
- not willing to work with at least one person living in the community who will be supportive of your recovery when you get out
- not interested in participating in the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Chillicothe Correctional Center
Chillicothe, Missouri, 64601
Franklin County Regional Jail
Frankfort, Kentucky, 40601
Kentucky Correctional Institution for Women
Pewee Valley, Kentucky, 40056
Women's Eastern Reception, Diagnostic and Correctional Center
Vandalia, Missouri, 63382
About this study
Official title: An Innovative, Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison
The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).
Read the detailed description
R61 Phase (Intervention adaptation): The TBRI intervention will be strategically adapted for CLS-involved women during the R61 to achieve 2 specific aims: 1) Adapt TBRI by focusing on adapting two intervention components - prison group sessions and re-entry recovery support - using focus groups with key stakeholders (N=30) including administrators, practitioners, and women with "lived experience," and target alignment with the unique treatment needs of the women and establish intervention approach feasibility; and 2) Pilot test the adapted intervention components in one group of women (n=8) at the KCIW facility. Final adaptations will be made to the TRUST manual for the R33 implementation.
R33 Phase (Intervention testing): The R33 will test the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release, while also collecting data on key constructs hypothesized to influence successful intervention implementation. The primary aim of the R33 is to examine effectiveness of the adapted TBRI Women's Re-entry Approach (TBRI-WRA) in reducing overdose risk among women (N=264) in four sites following release from prison-based SUD treatment. Study conditions include (1) Treatment as Usual (TAU, standard in-prison SUD treatment, n=88), (2) In-prison TBRI (TAU + TBRI prison-based sessions only; n=88), and (3) TBRI + Re-entry Recovery Support (TAU + prison-based TBRI sessions + Re-entry Recovery Support; n=88). The R33 will also examine implementation factors associated with study preparation, launch, sustainability, and scalability.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- TAU + TRUST, TAU + TRUST + Re-entry Recovery Support, Treatment as Usual (TAU)
- Keywords
- Overdose, Criminal legal system, Trust-based relational intervention (TBRI)
- Medical subject headings
- Substance-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + TRUSTBehavioural
The adapted TBRI WRA (Prison Only Component) titled TRUST will consist of an individual introductory module (1 hour) and a series of group modules (a minimum of 4 sessions, approximately 1-2 hours in length, delivered over the course of 3 months, with the final number and frequency to be determined in R61) focused on the core components of TBRI. The original TBRI approach includes a focus on group skills training; similarly, it is anticipated that R61 phase adaptations will meet the need for tailored skills training reflected by anticipated differences in the target population of women - including how their early attachment and trauma histories influence their current self-image and behavior (which likely has a tremendous impact on their relational attachments as adults). Group sessions will provide opportunities to build skills for regulating emotions and building healthy connections.
TAU + TRUST + Re-entry Recovery SupportBehavioural
This condition includes the proposed adapted TRUST intervention as well as on-going re-entry recovery support with the Safe Support Person (SSP). The SSP will be identified by the study participant as someone who will provide prosocial support during re-entry (e.g., support towards abstinence, establishing healthy recovery support relationships, rebuilding relationships with family and children) and in most cases will involve a close family member (mother, grandmother) or friend at the woman's identified home placement. This individual will be identified by the study participant as someone who is not involved in active substance use nor has a current legal system status (e.g., on probation).
Treatment as Usual (TAU)Other
Women in the TAU condition will not receive TRUST intervention services, but will receive traditional in-prison SUD treatment over 6 months as usual in the four targeted prison sites. The programs are separate units with the prisons and emphasize participation by all program members in the overall goal of addressing substance use and criminal thinking. Although trauma and violence are addressed as part of the holistic group process approach in these programs, these topics are not addressed from an on-going systematic or relational perspective and are not specifically addressed as part of re-entry planning.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Traditional in-prison SUD treatment Receives: Other: Treatment as Usual (TAU) |
| TRUST only | Experimental | Treatment as usual and the adapted version of TBRI for adult women (TRUST Intervention) Receives: Behavioral: TAU + TRUST |
| TRUST + Re-entry Recovery Support | Experimental | Treatment as usual, the adapted intervention (TRUST), and on-going re-entry recovery support with the Safe Support Person (SSP). Receives: Behavioral: TAU + TRUST + Re-entry Recovery Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overdose risk
Change in number of days of any substance from baseline to post-release using self-report data
Measured: Baseline and at 3 and 6 months post-release from prison
Secondary outcomes (1)
Change in trauma-related symptoms
Change in number of trauma-related symptoms associated with violence
Measured: Baseline and at 3 and 6 months post-release from prison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start9 Dec 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michele Staton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Michele Staton, University of Kentucky
- Investigators
- Michele Staton, MSW, PhD, Principal investigator, University of KentuckyKevin Knight, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651528
- Sponsor's protocol ID
- 94956
- Other IDs
- R33DA061365
- Acronym
- TRUST
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data at this time.
Publications
Staton M, Annett J, Carey P, Yang Y, Jones O, Bills L, Logan TK, Tillson M, Oser C, Knight K. Trauma-informed intervention to reduce substance use and to support community transition [TRUST]: Study protocol for a type 1 effectiveness-implementation hybrid trial to reduce overdose risk among justice-involved women. Trials. 2026 Apr 20;27(1):406. doi: 10.1186/s13063-026-09715-2.
PubMed 42010616
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative, Trauma-informed Approach for Reducing Overdose Risk Among Women Re-entering the Community From Prison
- ClinicalTrials.gov ID
- NCT06651528
- Acronym / sponsor ID
- TRUST / 94956
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- Overdose, Criminal legal system, Trust-based relational intervention (TBRI)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Michele StatonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).
Detailed description
R61 Phase (Intervention adaptation): The TBRI intervention will be strategically adapted for CLS-involved women during the R61 to achieve 2 specific aims: 1) Adapt TBRI by focusing on adapting two intervention components - prison group sessions and re-entry recovery support - using focus groups with key stakeholders (N=30) including administrators, practitioners, and women with "lived experience," and target alignment with the unique treatment needs of the women and establish intervention approach feasibility; and 2) Pilot test the adapted intervention components in one group of women (n=8) at the KCIW facility. Final adaptations will be made to the TRUST manual for the R33 implementation.
R33 Phase (Intervention testing): The R33 will test the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release, while also collecting data on key constructs hypothesized to influence successful intervention implementation. The primary aim of the R33 is to examine effectiveness of the adapted TBRI Women's Re-entry Approach (TBRI-WRA) in reducing overdose risk among women (N=264) in four sites following release from prison-based SUD treatment. Study conditions include (1) Treatment as Usual (TAU, standard in-prison SUD treatment, n=88), (2) In-prison TBRI (TAU + TBRI prison-based sessions only; n=88), and (3) TBRI + Re-entry Recovery Support (TAU + prison-based TBRI sessions + Re-entry Recovery Support; n=88). The R33 will also examine implementation factors associated with study preparation, launch, sustainability, and scalability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)Traditional in-prison SUD treatment |
| TRUST only | Experimental | Behavioral: TAU + TRUSTTreatment as usual and the adapted version of TBRI for adult women (TRUST Intervention) |
| TRUST + Re-entry Recovery Support | Experimental | Behavioral: TAU + TRUST + Re-entry Recovery SupportTreatment as usual, the adapted intervention (TRUST), and on-going re-entry recovery support with the Safe Support Person (SSP). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- participating in corrections-based SUD treatment
- have an anticipated parole eligibility date within 4 months
- self-identified history of violent victimization
- are willing to work with at least one person living in the community who will be supportive of your recovery when you get out
- interested in participating in the study
Key exclusion criteria (5 listed)
- not participating in corrections-based SUD treatment
- anticipated parole eligibility date greater than 4 months
- no self-identified history of violent victimization
- not willing to work with at least one person living in the community who will be supportive of your recovery when you get out
- not interested in participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + TRUSTThe adapted TBRI WRA (Prison Only Component) titled TRUST will consist of an individual introductory module (1 hour) and a series of group modules (a minimum of 4 sessions, approximately 1-2 hours in length, delivered over the course of 3 months, with the final number and frequency to be determined in R61) focused on the core components of TBRI. The original TBRI approach includes a focus on group skills training; similarly, it is anticipated that R61 phase adaptations will meet the need for tailored skills training reflected by anticipated differences in the target population of women - including how their early attachment and trauma histories influence their current self-image and behavior (which likely has a tremendous impact on their relational attachments as adults). Group sessions will provide opportunities to build skills for regulating emotions and building healthy connections. | Behavioural | TRUST only |
| TAU + TRUST + Re-entry Recovery SupportThis condition includes the proposed adapted TRUST intervention as well as on-going re-entry recovery support with the Safe Support Person (SSP). The SSP will be identified by the study participant as someone who will provide prosocial support during re-entry (e.g., support towards abstinence, establishing healthy recovery support relationships, rebuilding relationships with family and children) and in most cases will involve a close family member (mother, grandmother) or friend at the woman's identified home placement. This individual will be identified by the study participant as someone who is not involved in active substance use nor has a current legal system status (e.g., on probation). | Behavioural | TRUST + Re-entry Recovery Support |
| Treatment as Usual (TAU)Women in the TAU condition will not receive TRUST intervention services, but will receive traditional in-prison SUD treatment over 6 months as usual in the four targeted prison sites. The programs are separate units with the prisons and emphasize participation by all program members in the overall goal of addressing substance use and criminal thinking. Although trauma and violence are addressed as part of the holistic group process approach in these programs, these topics are not addressed from an on-going systematic or relational perspective and are not specifically addressed as part of re-entry planning. | Other | Treatment As Usual (TAU) |
Primary outcome
Change in overdose risk
Time frame: Baseline and at 3 and 6 months post-release from prison
Change in number of days of any substance from baseline to post-release using self-report data
1 secondary outcome
Change in trauma-related symptoms
Time frame: Baseline and at 3 and 6 months post-release from prison
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 42010616Staton M, Annett J, Carey P, Yang Y, Jones O, Bills L, Logan TK, Tillson M, Oser C, Knight K. Trauma-informed intervention to reduce substance use and to support community transition [TRUST]: Study protocol for a type 1 effectiveness-implementation hybrid trial to reduce overdose risk among justice-involved women. Trials. 2026 Apr 20;27(1):406. doi: 10.1186/s13063-026-09715-2.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele Staton, MSW, PhD principal investigator
University of Kentucky
Kevin Knight, PhD principal investigator
Texas Christian University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + TRUST, TAU + TRUST + Re-entry Recovery Support and Treatment as Usual (TAU) in people with Substance Use Disorder (SUD), run by Michele Staton at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overdose risk (time frame: Baseline and at 3 and 6 months post-release from prison). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.