Substance Use Disorders (SUDs)STEPSNCT07744841
Supportive Treatment With Enhanced Post-Incarceration Services
A study testing Individually Tailored Behavioral Activation and Formerly Incarcerated Transitions Program in people with Substance Use Disorders (SUDs), run by Catherine E. Paquette, PhD.
Trial summary
This study aims to improve health outcomes for people who use drugs after release from incarceration, a period of high risk for overdose and other adverse outcomes. It will examine an individually tailored behavioral activation (IT-BA) intervention integrated into a reentry primary care program with peer support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders (SUDs)
- What is being tested?
- Individually Tailored Behavioral Activation and Formerly Incarcerated Transitions Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jun 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18 years or older
- Have recent illicit drug use, defined as use of any illegal drug in the past week
- Meet DSM-5 criteria for a current (past 12 months) substance use disorder associated with any illegal drug
- Have been released from jail or prison (at least 30 consecutive days incarcerated) within the past year
Who cannot join
- Currently engaged in psychosocial treatment for drug use
- Unable to speak and understand English
- Unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care
This study aims to improve health outcomes for people who use drugs after release from incarceration, a period of high risk for overdose and other adverse outcomes. It will examine an individually tailored behavioral activation (IT-BA) intervention integrated into a reentry primary care program with peer support. The goal is to reduce substance use, improve mental health, and increase engagement in healthcare.
Read the detailed description
People who use drugs (PWUD) often experience adverse outcomes in the year following release from incarceration, including overdose, suicide, and infectious disease acquisition. Depressive symptoms and illicit drug use are key mediators of these adverse outcomes, and risk is compounded by low health service engagement among PWUD. Yet empirically supported interventions that directly target these mechanisms among people with past-year incarceration are lacking. The proposed study addresses this gap.
Current models that integrate medical care with peer support can improve outcomes for formerly incarcerated people but do not adequately address mental health and drug use. The Formerly Incarcerated Transitions (FIT) program in North Carolina employs the Transitions Care Network (TCN) model of reentry primary care enhanced with peer support and linkage to care (including medication for opioid use disorder). Research on the TCN has demonstrated positive outcomes for individuals with recent incarceration, yet PWUD in these programs often continue to use drugs and have low engagement in behavioral health services. There is a need for integrated care models that incorporate tailored treatment approaches to engage more PWUD in treatment for mental and behavioral health after incarceration.
Individually Tailored Behavioral Activation (IT-BA) represents a promising intervention approach for PWUD that would complement integrated care models like the TCN. Behavioral Activation (BA) is an empirically supported intervention that is effective in treating both substance use disorder (SUD) and depression. IT-BA is an individually tailored, low-barrier version of BA that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among PWUD. However, it has not yet been studied as part of integrated care models or among people with past-year incarceration, who experience the greatest risk of adverse health outcomes. This study will evaluate IT-BA as an adjunct to the FIT program for PWUD with recent incarceration. Combining IT-BA with enhanced reentry primary care will target multiple mechanisms contributing to post-release adverse outcomes among PWUD, including depressive symptoms, illicit drug use, and health service disengagement.
The overall goal of this research project is to evaluate an individually tailored behavioral intervention, combined with enhanced reentry primary care for drug use, to address the complex health and behavioral needs of PWUD experiencing recent incarceration.
Specific Aims:
- Aim 1: Identify barriers and facilitators to implementing individually tailored behavior therapy for drug use in a primary care setting.
- Aim 2: Develop a protocol for integrating the IT-BA treatment with the FIT program using a community-engaged approach.
- Aim 3: Test the feasibility, acceptability, and initial efficacy of IT-BA as an adjunct to the FIT enhanced reentry primary care program.
- Conditions
- Substance Use Disorders (SUDs)
- Being tested
- Individually Tailored Behavioral Activation, Formerly Incarcerated Transitions Program
- Keywords
- Incarceration, Reentry, Peer Support, Addiction, Drug Use, Primary Care, Community Health Workers, Behavioral Activation, Behavior Therapy
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually Tailored Behavioral ActivationBehavioural
Also called IT-BA
IT-BA is an individually tailored, low-barrier version of Behavioral Activation (BA) that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among people who use drugs (PWUD). IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments.
Formerly Incarcerated Transitions ProgramBehavioural
Also called FIT, FIT TAU
The FIT program provides integrated medical care enhanced with peer support and linkage to care for individuals who have been incarcerated within the past year and have at least one chronic health condition, including substance use disorders. After the intake assessment, which includes evaluation of medical and psychosocial needs, community health workers (CHWs) provide peer support and help connect patients to appropriate services at FIT clinic sites and in the community based on their individual needs and goals. CHWs also assist with transportation to/from appointments and may provide smartphones with cellular and internet service to facilitate engagement in care. All FIT patients are also assigned a FIT primary care provider (with appointments coordinated by the CHW), and patients with opioid use disorder are offered an appointment with an MOUD provider. After initial coordination of care, CHWs maintain contact with FIT patients as needed to provide ongoing support
| Study group | Role | What they receive |
|---|---|---|
| FIT TAU | Active comparator | Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU). As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. All participants will also receive referrals to behavioral health services in the community. Receives: Behavioral: Formerly Incarcerated Transitions Program |
| FIT + IT-BA | Experimental | Formerly Incarcerated Transitions (FIT) program engagement with an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments. All participants will also receive referrals to behavioral health services in the community. Receives: Behavioral: Individually Tailored Behavioral Activation; Behavioral: Formerly Incarcerated Transitions Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Attendance (Feasibility)
Assessed via attendance at IT-BA treatment sessions, with primary outcomes being treatment uptake (attending ≥1 session) and adherence (attending ≥6 of 12 sessions). Range 0-12 sessions; Higher number indicates greater attendance (positive outcome).
Measured: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks
Therapeutic Alliance (Acceptability)
Measured using the Working Alliance Inventory - Short Form, Revised (WAI-SR). Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
Measured: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Treatment Satisfaction (Acceptability)
Measured using the Client Satisfaction Questionnaire (CSQ-8). Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Measured: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Substance use
Measured using the Timeline Follow-Back (TLFB) interview, which assesses frequency and quantity of substance use via calendar-based, semi-structured interview. Higher scores indicate greater substance use frequency or quantity (negative outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Depressive Symptoms
Measured using the Patient Health Questionnaire 9 (PHQ-9 Depression). Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Healthcare Engagement
Defined as the total number of outpatient visits during the assessment period, including primary care, medications for opioid use disorder (MOUD), and behavioral health services.
Data sources: self-report; confirmed via electronic health records (EHR). Higher number indicates greater healthcare engagement (positive outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Secondary outcomes (8)
HIV risk behaviors
Measured using HIV Risk Behavior Scale (HRBS). Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Opioid overdose risk behavior
Measured using the Opioid Overdose Risk Behavior Scale, v.2 (ORBS-2). Scale range 0-30, higher scores indicate greater overdose risk behavior (negative outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Overdose events
Number of overdose events, via self-report. Higher number of overdose events is a negative outcome.
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Readiness to change drug use
Measured using the Contemplation Ladder for Drugs. Scale range 1-7, higher scores indicate greater readiness to change (positive outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Steps to change drug use
Measured using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) - Taking Steps subscale. Scale range 8-40, higher scores indicate greater steps to change drug use (positive outcome)
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
DSM-5 SUD symptoms
Measured using the DSM-5 Substance Use Symptom Checklist. Scale range 0-11, higher scores reflect greater number of SUD symptoms (negative outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Behavioral activation
Measured using the Behavioral Activation for Depression Scale (BADS). Scale range 0-150, higher scores indicate greater activation (positive outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Environmental Reward
Measured using the Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome).
Measured: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorders (SUDs)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adults with current substance use disorders (SUDs) who have been incarcerated in the past year will be recruited from community-based settings and randomly assigned in equal distribution to one of two arms: 1) Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU); or 2) FIT program engagement + an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments. All participants will also receive referrals to behavioral health services in the community.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catherine E. Paquette, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Catherine E. Paquette, PhD, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744841
- Sponsor's protocol ID
- Pro00120118
- Other IDs
- 1K23DA063795-01
- Acronym
- STEPS
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be stored long-term in the Duke Research Data Repository following the completion of the study. This repository requires researchers to formally apply to use the data and obtain approval prior to gaining access.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care
- ClinicalTrials.gov ID
- NCT07744841
- Acronym / sponsor ID
- STEPS / Pro00120118
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- Incarceration, Reentry, Peer Support, Addiction, Drug Use, Primary Care, Community Health Workers, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Catherine E. Paquette, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 Aug 2026 (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.
This study aims to improve health outcomes for people who use drugs after release from incarceration, a period of high risk for overdose and other adverse outcomes. It will examine an individually tailored behavioral activation (IT-BA) intervention integrated into a reentry primary care program with peer support. The goal is to reduce substance use, improve mental health, and increase engagement in healthcare.
Detailed description
People who use drugs (PWUD) often experience adverse outcomes in the year following release from incarceration, including overdose, suicide, and infectious disease acquisition. Depressive symptoms and illicit drug use are key mediators of these adverse outcomes, and risk is compounded by low health service engagement among PWUD. Yet empirically supported interventions that directly target these mechanisms among people with past-year incarceration are lacking. The proposed study addresses this gap.
Current models that integrate medical care with peer support can improve outcomes for formerly incarcerated people but do not adequately address mental health and drug use. The Formerly Incarcerated Transitions (FIT) program in North Carolina employs the Transitions Care Network (TCN) model of reentry primary care enhanced with peer support and linkage to care (including medication for opioid use disorder). Research on the TCN has demonstrated positive outcomes for individuals with recent incarceration, yet PWUD in these programs often continue to use drugs and have low engagement in behavioral health services. There is a need for integrated care models that incorporate tailored treatment approaches to engage more PWUD in treatment for mental and behavioral health after incarceration.
Individually Tailored Behavioral Activation (IT-BA) represents a promising intervention approach for PWUD that would complement integrated care models like the TCN. Behavioral Activation (BA) is an empirically supported intervention that is effective in treating both substance use disorder (SUD) and depression. IT-BA is an individually tailored, low-barrier version of BA that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among PWUD. However, it has not yet been studied as part of integrated care models or among people with past-year incarceration, who experience the greatest risk of adverse health outcomes. This study will evaluate IT-BA as an adjunct to the FIT program for PWUD with recent incarceration. Combining IT-BA with enhanced reentry primary care will target multiple mechanisms contributing to post-release adverse outcomes among PWUD, including depressive symptoms, illicit drug use, and health service disengagement.
The overall goal of this research project is to evaluate an individually tailored behavioral intervention, combined with enhanced reentry primary care for drug use, to address the complex health and behavioral needs of PWUD experiencing recent incarceration.
Specific Aims:
- Aim 1: Identify barriers and facilitators to implementing individually tailored behavior therapy for drug use in a primary care setting.
- Aim 2: Develop a protocol for integrating the IT-BA treatment with the FIT program using a community-engaged approach.
- Aim 3: Test the feasibility, acceptability, and initial efficacy of IT-BA as an adjunct to the FIT enhanced reentry primary care program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adults with current substance use disorders (SUDs) who have been incarcerated in the past year will be recruited from community-based settings and randomly assigned in equal distribution to one of two arms: 1) Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU); or 2) FIT program engagement + an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments. All participants will also receive referrals to behavioral health services in the community.
| Arm | Type | Receives |
|---|---|---|
| FIT TAU | Active comparator | Behavioral: Formerly Incarcerated Transitions ProgramFormerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU). As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. All participants will also receive referrals to behavioral health services in the community. |
| FIT + IT-BA | Experimental | Behavioral: Individually Tailored Behavioral Activation, Behavioral: Formerly Incarcerated Transitions ProgramFormerly Incarcerated Transitions (FIT) program engagement with an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments. All participants will also receive referrals to behavioral health services in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged 18 years or older
- Have recent illicit drug use, defined as use of any illegal drug in the past week
- Meet DSM-5 criteria for a current (past 12 months) substance use disorder associated with any illegal drug
- Have been released from jail or prison (at least 30 consecutive days incarcerated) within the past year
Key exclusion criteria (3 listed)
- Currently engaged in psychosocial treatment for drug use
- Unable to speak and understand English
- Unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia)
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 |
|---|---|---|
| Individually Tailored Behavioral ActivationAlso: IT-BAIT-BA is an individually tailored, low-barrier version of Behavioral Activation (BA) that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among people who use drugs (PWUD). IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments. | Behavioural | FIT + IT-BA |
| Formerly Incarcerated Transitions ProgramAlso: FIT, FIT TAUThe FIT program provides integrated medical care enhanced with peer support and linkage to care for individuals who have been incarcerated within the past year and have at least one chronic health condition, including substance use disorders. After the intake assessment, which includes evaluation of medical and psychosocial needs, community health workers (CHWs) provide peer support and help connect patients to appropriate services at FIT clinic sites and in the community based on their individual needs and goals. CHWs also assist with transportation to/from appointments and may provide smartphones with cellular and internet service to facilitate engagement in care. All FIT patients are also assigned a FIT primary care provider (with appointments coordinated by the CHW), and patients with opioid use disorder are offered an appointment with an MOUD provider. After initial coordination of care, CHWs maintain contact with FIT patients as needed to provide ongoing support | Behavioural | FIT + IT-BA, FIT TAU |
Primary outcome
Treatment Attendance (Feasibility)
Time frame: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks
Assessed via attendance at IT-BA treatment sessions, with primary outcomes being treatment uptake (attending ≥1 session) and adherence (attending ≥6 of 12 sessions). Range 0-12 sessions; Higher number indicates greater attendance (positive outcome).
Therapeutic Alliance (Acceptability)
Time frame: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Measured using the Working Alliance Inventory - Short Form, Revised (WAI-SR). Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
Treatment Satisfaction (Acceptability)
Time frame: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Measured using the Client Satisfaction Questionnaire (CSQ-8). Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Substance use
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Measured using the Timeline Follow-Back (TLFB) interview, which assesses frequency and quantity of substance use via calendar-based, semi-structured interview. Higher scores indicate greater substance use frequency or quantity (negative outcome).
Depressive Symptoms
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Measured using the Patient Health Questionnaire 9 (PHQ-9 Depression). Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Healthcare Engagement
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Defined as the total number of outpatient visits during the assessment period, including primary care, medications for opioid use disorder (MOUD), and behavioral health services. Data sources: self-report; confirmed via electronic health records (EHR). Higher number indicates greater healthcare engagement (positive outcome).
8 secondary outcomes
HIV risk behaviors
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Opioid overdose risk behavior
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Overdose events
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Readiness to change drug use
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Steps to change drug use
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
DSM-5 SUD symptoms
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Behavioral activation
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
Environmental Reward
Time frame: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.
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 4 Aug 2026.
- NC Formerly Incarcerated Transition ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified study data will be stored long-term in the Duke Research Data Repository following the completion of the study. This repository requires researchers to formally apply to use the data and obtain approval prior to gaining access.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Individually Tailored Behavioral Activation and Formerly Incarcerated Transitions Program in people with Substance Use Disorders (SUDs), run by Catherine E. Paquette, PhD.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Catherine Paquette, PhD (+1 919-681-6801, catherine.paquette@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Attendance (Feasibility) (time frame: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.