Clinical trial NCT06682364: Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women
Official title: Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: women
criminal justice
substance use
opioid use disorder
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants enrolled and retained in the intervention
timeFrame: 6 months of follow-up for participants
Secondary outcomes:
measure: Preliminary substance use outcomes
timeFrame: 6 months of follow-up for participants
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Recovery, Advocacy, Service, and Empowerment (RASE)
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Abenaa Jones, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: