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Completed

NCT Number: NCT06682364

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Recovery, Advocacy, Service, and Empowerment (RASE)

Harrisburg, Pennsylvania, 17109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 18+ years of age
  • Pennsylvania resident and intends to remain in or near Harrisburg, Carlisle, York or Lancaster areas for the duration of the study
  • Use opioids illicitly
  • 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
  • Not currently pregnant, planning to become pregnant, or breastfeeding during the study period
  • 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

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

Treatment and study plan

Trauma-informed case management for women who use drugs

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

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.

Primary outcomes

  1. Number of participants enrolled and retained in the intervention

    Time frame: 6 months of follow-up for participants

    We will assess the feasibility of this pilot study by assessing the number of participants recruited and retained for the entire six-month duration of the intervention.

Secondary outcomes

  1. Preliminary substance use outcomes

    Time frame: 6 months of follow-up for participants

    The investigators will assess participants' urine drug screen results at baseline, 3-month follow-up, and 6-month follow-up.

Sponsors and collaborators

Lead sponsor

Abenaa Jones, Ph.D.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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