Overdose Prevention for Opioid Use Disorder

(WJCOIN-II Trial)

Overseen By Michele Staton, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michele Staton

Disqualifiers: Not living in rural area, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women at risk of opioid overdose as they transition from jail back to rural communities. It tests various support methods, such as recovery coaching, engaging a supportive person, and incentive-based programs to encourage sobriety. The goal is to reduce overdose risks by providing resources and building connections. This trial is part of the Overdose Prevention Intervention Package (OPIP). Women with a history of opioid or stimulant use who are preparing for release from jail might be suitable candidates, especially if they have someone willing to support them through their recovery process. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for overdose prevention and recovery support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that public health programs, like the one tested in this trial, can help reduce deaths from opioid overdoses. For instance, one study found a significant drop in both overdose deaths and the number of people with opioid use disorder over time. These programs typically focus on education, harm reduction strategies, and providing tools like naloxone, a medication that can reverse overdoses, to those at risk.

The trial's Overdose Prevention Intervention Package (OPIP) includes recovery coaching, involving a support person, and using rewards to encourage positive behavior. Although specific safety data for OPIP is not yet available, similar programs have been safe in other settings. They emphasize offering support and resources instead of medication, which usually results in fewer side effects.

Overall, these strategies aim to make it safer for women at risk of overdose to return to their communities. The focus on practical support generally ensures the safety of participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Overdose Prevention Intervention Package (OPIP) because it offers a holistic approach to addressing opioid use disorder (OUD) that goes beyond standard medications like methadone or buprenorphine. Unlike traditional treatments, OPIP combines recovery coaching with strategies like Safe Person Engagement and Contingency Management. Recovery coaching offers personal support from individuals with lived experience, while Safe Person Engagement involves training a supportive friend or family member to help reduce overdose risk. Contingency Management adds an incentive-based program to encourage abstinence and engagement in treatment. This comprehensive package aims to tackle the social and behavioral aspects of OUD, potentially leading to more effective long-term recovery outcomes.

What evidence suggests that this trial's treatments could be effective for overdose prevention?

This trial will evaluate the effectiveness of the Overdose Prevention Intervention Package (OPIP) through various treatment arms. Studies have shown that public health programs like OPIP can significantly reduce deaths from opioid overdoses. For example, one study found a 29.9% drop in these deaths. In this trial, participants in different arms will receive interventions such as recovery coaching, which offers support and resources to people returning to the community, helping them meet basic needs and lowering their risk of overdose. Some arms will also include additional components like Safe Person Engagement or Contingency Management. Programs that provide naloxone, a medication that can reverse overdoses, and teach people how to use it, have successfully lowered the number of fatal overdoses. These strategies aim to keep individuals safe and prevent relapse during important transition times. ^{1 4 6 7 8}

Who Is on the Research Team?

Michele Staton, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for women in Kentucky's criminal legal system who are at risk of overdose after leaving jail. They must be willing to consider substance use disorder treatment, have a release date within 7-60 days, and provide a support person's contact info. Participants need DSM-5 scores of 2+ for opioid or stimulant use disorders without cognitive impairments.

Inclusion Criteria

I have a diagnosis of opioid or stimulant use disorder.

I understand and can make decisions about my health care.

I will be released within 7 to 60 days, allowing time for sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-release Intervention

Participants receive Recovery Coaching (RC) and may also receive Support Person Engagement (SPE) to prepare for community re-entry and reduce overdose risk.

Varies

Post-release Intervention

Continuation of pre-release interventions with the addition of Contingency Management (CM) to incentivize target behaviors such as meeting with RC and maintaining abstinence.

12 weeks

Follow-up

Participants are monitored for overdose risk and treatment entry at 3, 6, and 12 months post-release.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Overdose Prevention Intervention Package (OPIP)

Trial Overview The study tests an Overdose Prevention Intervention Package (OPIP) designed to reduce the risk of overdosing as women transition from jail back into rural communities. It aims to improve how the criminal legal system responds to the overdose crisis by providing access to prevention strategies.

How Is the Trial Designed?

Group I: Recovery Coaching Only Experimental Treatment 1 Intervention

Following the clinical assessment, all participants will receive the "base" recovery coaching intervention pre-release. RCs will be employed by VOH and will be women with lived experience with OUD/StUD recovery and CLS involvement who will provide strengths-based, person-centered recovery coaching sessions designed to reduce overdose risk. Women will meet with the RC pre-release to assess basic re-entry needs associated with entering treatment (e.g., lack of housing, food, clothing, transportation, employment). RCs will have access to a "barrier relief fund" to address these needs (e.g., clothes for an interview, transportation vouchers) following established RC protocols. At discharge, all women will be provided re-entry transition kits (e.g., hygiene items, condoms, overdose prevention resources) and naloxone.

Group II: Recovery Coaching + Support Person Eng + Contingency Management Experimental Treatment 1 Intervention

Women in this intervention condition will participate in the RC condition (pre- and post-release), the SPE sessions (pre- and post-release), and CM post-release.

Group III: Recovery Coaching + Safe Person Engagement Experimental Treatment 1 Intervention

Women in this condition will receive the base (RC) pre-release intervention and the Support Person Engagement (SPE) component pre- and post-release. Support Person (SP) designation will draw upon 1) the woman's suggested SP at screening, 2) baseline social network data, and 3) the initial RC meeting. Identified SPs will be screened for eligibility, including being over the age of 18 and willing to engage in intervention sessions. Exclusion criteria for SPs (based on participant and SP self-report) includes past felony conviction, currently incarcerated, on community supervision, or prior history of domestic violence/EPOs. All SPE sessions will align with overdose risk education, understanding treatment options (including MOUD), naloxone distribution, and harm reduction strategies to keep the woman safe during community re-entry. SPs will have access to free naloxone to carry and distribute.

Group IV: Recovery Coaching + Contingency Management Experimental Treatment 1 Intervention

Women randomized to this group will receive the base pre-release RC intervention, 12 weeks of RC meetings post-release, and 12 weeks of CM post-release. Women will be informed before jail release of the expectations in the CM protocol, target behaviors, and incentive opportunities. The WJCOIN-II CM protocol will be an adapted version of Petry and Martin's approach to reinforce three target verifiable behaviors: 1) meeting with the RC; 2) stimulant abstinence; and 3) opioid abstinence using saliva drug screens. At the conclusion of weekly post-release RC sessions, research staff will join the video call for CM. Virtual CM is feasible, acceptable, and comparable to in-person CM, and research staff will administer CM separately to maintain the integrity of the RC/participant rapport. If the participant does not meet with their RC by the last day of a given week, research staff will contact the participant separately for a CM session.

Who Is Running the Clinical Trial?

Michele Staton

Lead Sponsor

Trials

5

Recruited

1,600+

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

2. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01327-4

Allocative efficiency of opioid overdose prevention strategies ... Increasing community naloxone distribution does not impact overdose but decreases probability an overdose is fatal. Individuals may die of ...

3. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/moud-study.html

Medications for Opioid Use Disorder (MOUD) Study The MOUD study examined patient outcomes from several opioid use disorder (OUD) treatments.

4. science.org science.org/doi/10.1126/sciadv.abm8147

Reducing opioid use disorder and overdose deaths in the ... It achieved a maximum annual reduction of 29.9% in opioid overdose deaths and 15.1% in OUD prevalence in 2032, while, cumulatively, the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871620304300

Evaluation of a personally-tailored opioid overdose ... This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users.

6. health.state.mn.us health.state.mn.us/communities/overdose/prevent/practices.html

Promising Overdose Prevention Practices Promising opioid overdose prevention practices include upstream actions and evidence-based practices. Explore some of the options in the ...

7. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/index.html

Data Resources | Overdose Prevention Access CDC's interactive data dashboards and visualizations, including fatal overdose data, nonfatal overdose data, and US dispensing rate maps.

8. library.samhsa.gov library.samhsa.gov/product/overdose-prevention-response-toolkit/pep23-03-00-001

Overdose Prevention and Response Toolkit SAMHSA's updated Overdose Prevention and Response Toolkit provides guidance to a wide range of individuals on preventing and responding to an overdose.