Opioid Use DisorderNCT06682364
Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women
A study testing Trauma-informed case management for women who use drugs and CRS Only Intervention in people with Opioid Use Disorder, run by Abenaa Jones, Ph.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Trauma-informed case management for women who use drugs and CRS Only Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Recovery, Advocacy, Service, and Empowerment (RASE)
Harrisburg, Pennsylvania, 17109
About this study
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.
- Conditions
- Opioid Use Disorder
- Being tested
- Trauma-informed case management for women who use drugs, CRS Only Intervention
- Keywords
- women, criminal justice, substance use, opioid use disorder
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-informed case management for women who use drugsBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case management using certified recovery specialists | Active comparator | 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. Receives: Behavioral: Trauma-informed case management for women who use drugs; Behavioral: CRS Only Intervention |
| Case management using certified recovery specialists + Trauma Support Group | Experimental | 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. Receives: Behavioral: Trauma-informed case management for women who use drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled and retained in the intervention
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.
Measured: 6 months of follow-up for participants
Secondary outcomes (1)
Preliminary substance use outcomes
The investigators will assess participants' urine drug screen results at baseline, 3-month follow-up, and 6-month follow-up.
Measured: 6 months of follow-up for participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start13 Nov 2024
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abenaa Jones, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Abenaa Jones, Ph.D., Penn State University
- Investigators
- Abenaa Jones, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682364
- Sponsor's protocol ID
- STUDY00023933
- Other IDs
- K01DA051715
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be deposited into the National Addiction and HIV Data Archive Program
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women
- ClinicalTrials.gov ID
- NCT06682364
- Acronym / sponsor ID
- STUDY00023933
- Conditions
- Opioid Use Disorder
- Keywords
- women, criminal justice, substance use, opioid use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Abenaa Jones, Ph.D.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 12 Nov 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management using certified recovery specialists | Active comparator | Behavioral: Trauma-informed case management for women who use drugs, Behavioral: CRS Only InterventionThe 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. |
| Case management using certified recovery specialists + Trauma Support Group | Experimental | Behavioral: Trauma-informed case management for women who use drugsIncludes 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Trauma-informed case management for women who use drugsThis 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. | Behavioural | Case management using certified recovery specialists, Case management using certified recovery specialists + Trauma Support Group |
| CRS Only InterventionThis 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. | Behavioural | Case management using certified recovery specialists |
Primary outcome
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.
1 secondary outcome
Preliminary substance use outcomes
Time frame: 6 months of follow-up for participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited into the National Addiction and HIV Data Archive Program
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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. This study is not recruiting at the moment.
Abenaa Jones, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-informed case management for women who use drugs and CRS Only Intervention in people with Opioid Use Disorder, run by Abenaa Jones, Ph.D. at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants enrolled and retained in the intervention (time frame: 6 months of follow-up for participants). 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 6 Apr 2026.