MOUD Pre-Treatment + Telehealth for Opioid Use Disorder

(W-JCOIN Trial)

Not currently recruiting at 8 trial locations

Overseen By Michele Staton, MSW, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michele Staton

Must be taking: MOUD

Disqualifiers: Cognitive impairment

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of starting medication for opioid use disorder (MOUD) through telehealth, with and without peer navigator support. It focuses on helping incarcerated women in Kentucky begin and continue treatment after release from jail. The trial connects participants with MOUD providers via telehealth, testing this approach alone and with additional peer support. It seeks women who have been in jail for at least a week, are willing to start MOUD, and have a history of opioid use. As an unphased trial, participants contribute to innovative research that may improve treatment access for others.

Do I need to stop my current medications to join the trial?

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.

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

Research has shown that using telehealth for treating opioid use disorder (OUD) is generally well-received. Studies have found that patients using telehealth maintain their treatment as effectively as those receiving in-person care. This indicates that telehealth is a safe way to provide medication for opioid use disorder (MOUD).

Adding a peer navigator, who offers extra support, to the telehealth approach might help individuals manage their treatment more effectively. Although specific safety data on adding a peer navigator is limited, this combination aims to enhance support without increasing risk.

Overall, using telehealth, with or without a peer navigator, for OUD treatment does not result in more negative side effects compared to traditional methods. This suggests it is a safe option for those considering participation in a clinical trial using these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the MOUD Pre-Treatment Telehealth and MOUD Pre-Treatment Telehealth with Peer Navigator because these approaches could transform how opioid use disorder is managed. Unlike traditional in-person therapy or medication-assisted treatments, these methods use telehealth to connect patients with community MOUD providers, offering convenient access to care. The addition of a Peer Navigator provides personalized guidance and support, enhancing the treatment experience. These innovations could improve accessibility and engagement, potentially leading to better outcomes for individuals struggling with opioid addiction.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research shows that using telehealth to provide medication for opioid use disorder (MOUD) can help more people begin and continue their treatment. In this trial, participants may receive MOUD Pre-Treatment Telehealth, which has made it easier for people in rural areas to access MOUD, allowing them to get the help they need. Another option in this trial is MOUD Pre-Treatment Telehealth and Peer Navigator, which includes a peer navigator to guide and support patients. Studies suggest that this approach can further increase the likelihood of people starting and continuing MOUD after being released from jail. This method benefits women in particular, with nearly half starting substance use treatment soon after leaving jail. Overall, these findings suggest that telehealth, especially with peer support, can effectively improve the success of MOUD treatment. ^{2 3 6 7 8}

Who Is on the Research Team?

Michele Staton, MSW, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for incarcerated women in Kentucky who have been jailed for at least a week, show significant opioid use with an ASSIST score of 4 or more, and are willing to start treatment for opioid addiction. It's not open to the public and excludes those with cognitive impairments.

Inclusion Criteria

Incarceration period of at least 7 days

You must agree to participate in medication treatment before starting the study.

You have used opioid drugs (prescription or street) frequently and have a high score on a screening test called ASSIST.

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MOUD PreTreatment Telehealth

Participants are connected via telehealth to the community MOUD provider for a psychosocial assessment and medical evaluation.

4 weeks

1 initial telehealth visit, ongoing telehealth sessions

MOUD PreTreatment Telehealth + Peer Navigation

In addition to telehealth, participants receive support from a Peer Navigator for community MOUD initiation and maintenance.

12 weeks

Weekly telephone recovery services

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recidivism and criminal activity.

13 months

What Are the Treatments Tested in This Trial?

Interventions

• MOUD Pre-Treatment Telehealth
• MOUD Pre-Treatment Telehealth and Peer Navigator
• Services as Usual

Trial Overview The study tests if telehealth services before release from jail can help women start and stick with medication treatments for opioid addiction. Some will also get support from peers who've had similar experiences, while others receive usual care without these additions.

How Is the Trial Designed?

Group I: MOUD Pre-Treatment Telehealth and Peer Navigator Experimental Treatment 1 Intervention

Telehealth connection to a community MOUD provider, in addition to a peer navigator

Group II: MOUD Pre-Treatment Telehealth Experimental Treatment 1 Intervention

Telehealth connection to a community MOUD provider.

Group III: Services as Usual (SAU) Active Control 1 Intervention

Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.

Who Is Running the Clinical Trial?

Michele Staton

Lead Sponsor

Trials

5

Recruited

1,600+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A study of Veterans with opioid use disorder found that using telehealth for counseling significantly reduced the likelihood of discontinuing buprenorphine treatment compared to traditional in-person visits, with a hazard ratio of 0.69 for both substance use and mental health services.

Patients who exclusively used telehealth had an even lower risk of treatment discontinuation (hazard ratios of 0.48 for substance use and 0.46 for mental health), suggesting that telehealth can effectively support ongoing engagement in treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. Vakkalanka, JP., Lund, BC., Ward, MM., et al.[2022]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

Telehealth-delivered medication-assisted treatment for opioid use disorder (tele-MOUD) has shown favorable outcomes, including improved retention and abstinence rates, as well as positive experiences from both clinicians and patients, despite the need for more long-term assessments.

Challenges remain, particularly for underserved populations with limited access to technology, highlighting the need for additional support and permanent regulatory reforms to enhance the effectiveness and reach of tele-MOUD services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-Based Delivery of Medication-Assisted Treatment for Opioid Use Disorder: a Critical Review of Recent Developments. Mahmoud, H., Naal, H., Whaibeh, E., et al.[2022]

Patients using a fully virtual telemedicine service for opioid use disorder (tele-OUD) reported significant advantages, including a more patient-centered approach and reduced social barriers to treatment, based on interviews with 20 adults who had received 3 to 5 weeks of care.

Nearly all participants appreciated the quick initiation of medication for opioid use disorder (MOUD) through tele-OUD, indicating its potential effectiveness in improving access to treatment, although further research is needed to assess long-term outcomes and suitability for different recovery stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. Sousa, JL., Raja, P., Huskamp, HA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167081/

Emergency Department-Based Medication for Opioid Use ... Outcomes included the number of patients inducted over 5 years (2019-2023), the number inducted through telehealth, and the retention rate in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S037687162500081X

The opioid epidemic in rural communities: Can telehealth ... This paper examines rural telehealth use, its impact on medication for opioid use disorder (MOUD) provision, and issues that require attention for sustainment.

3. withpower.com withpower.com/trial/phase-opioid-related-disorders-11-2020-66c98

MOUD Pre-Treatment + Telehealth for Opioid Use Disorder ... This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04069624

Kentucky Women's Justice Community Opioid Innovation ... This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827185

Smartphone App–Based Contingency Management and ... These findings suggest that adding app-based contingency management to MOUD is associated with better treatment outcomes in clinical settings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10396057/

Use of telehealth for opioid use disorder treatment in safety ... This mixed methods study examines characteristics associated with having the majority of OUD-related visits via telehealth versus in-person, and changes in mode ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05832879

Telehealth Treatment for Opioid Use Disorders This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its ...

8. health.ny.gov health.ny.gov/health_care/medicaid/ebbrac/2025/docs/2025-07_hlth_tech_assessment.pdf

Treatment of Opioid Use Disorder Delivered Exclusively by ... These studies found treatment of OUD exclusively by telehealth was not significantly different for retention in treatment outcomes or rates of.