Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Opioid-related overdose deaths and incarceration rates have skyrocketed and have disproportionately affected women. Despite having a higher burden of substance use disorders and HIV/AIDS than criminal justice-involved (CJI) men, CJI women are less likely to have access to substance use and HIV treatment. The planned research aims to improve how women in the criminal justice system connect to and stay in drug treatment. This will be done by creating and putting into practice a well-researched program specifically designed for women, considering their experiences with trauma. The program incorporates several best practices in substance use treatment such as the use of Certified Peer Recovery Specialists (CRS) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare. In addition, half of the women will be randomly selected to participate in a 12-session trauma support group led by CRS which uses the evidence-based curriculum, Beyond Trauma, which was specifically designed for women who use drugs. The aforementioned components are rarely offered in tandem with substance use treatment, and as such, this research is assessing if having this comprehensive program is linked with better substance use and social outcomes. The overall goal is to reduce the problem of opioid addiction and overdoses among women who have recently been involved in the criminal justice system and to reduce the barriers to opioid addiction treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gender-Responsive Treatment for Women Offenders - 1

NCT00249613

Substance Abuse Problem

COMPLETED NA

A Brief Alcohol Intervention for Incarcerated Women

NCT00237003

Alcohol Use Incarceration

COMPLETED PHASE3

Colorado Women's TC Project

NCT00249561

Substance-Related Disorders

COMPLETED PHASE1/PHASE2

Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition

NCT06651528

Substance Use Disorder (SUD)

ENROLLING_BY_INVITATION NA

Criminal Justice Coordinated Transitional Care

NCT05376371

HIV Hepatitis C Substance Use Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case management using certified recovery specialists

The arm incorporates several best practices in substance use treatment such as the use of Certified Peer Recovery Specialists (CRS) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare.

Group Type ACTIVE_COMPARATOR

Trauma-informed case management for women who use drugs

Intervention Type BEHAVIORAL

This intervention assesses the adequacy in which components of the gender-specific and trauma-informed intervention function together using a sample of 50 community-recruited CJI women who use opioids illicitly.

CRS Only Intervention

Intervention Type BEHAVIORAL

This intervention assesses the adequacy in which components of the gender-specific case management by certified peer recovery specialists function together using a sample of 50 community-recruited CJI women who use opioids illicitly.

Case management using certified recovery specialists + Trauma Support Group

Includes all the components in the comparative arm and a 12-session trauma support group led by CRS, which uses the evidence-based curriculum, Beyond Trauma, which was specifically designed for women who use drugs.

Group Type EXPERIMENTAL

Trauma-informed case management for women who use drugs

Intervention Type BEHAVIORAL

This intervention assesses the adequacy in which components of the gender-specific and trauma-informed intervention function together using a sample of 50 community-recruited CJI women who use opioids illicitly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trauma-informed case management for women who use drugs

This intervention assesses the adequacy in which components of the gender-specific and trauma-informed intervention function together using a sample of 50 community-recruited CJI women who use opioids illicitly.

Intervention Type BEHAVIORAL

CRS Only Intervention

This intervention assesses the adequacy in which components of the gender-specific case management by certified peer recovery specialists function together using a sample of 50 community-recruited CJI women who use opioids illicitly.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female
2. 18+ years of age
3. Pennsylvania resident and intends to remain in or near Harrisburg, Carlisle, York or Lancaster areas for the duration of the study
4. Use opioids illicitly
5. Interested in starting drug treatment that uses medication to stop opioid use OR are currently in a drug treatment program for opioid use that uses medication but feel that without additional support they won't be able to continue with the program
6. Not currently pregnant, planning to become pregnant, or breastfeeding during the study period
7. Released from a jail or prison within the past 12 months or have other criminal justice involvement (arrests, probation, or parole) within the past 12 months.

Exclusion Criteria

1. Not female
2. Under 18 years of age
3. Not a Pennsylvania resident or no intention to remain in or near Harrisburg/Carlisle/York or Lancaster areas for the duration of the study
4. Do not use opioids illicitly
5. Not interested in MOUD to stop opioid use
6. No arrests, probation or parole, nor released from a jail or prison within the past 12 months
7. Pregnant, planning to become pregnant, or breastfeeding during the study period

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No