MOUD Pre-Treatment + Telehealth for Opioid Use Disorder

(W-JCOIN Trial)

Recruiting at 8 trial locations

Overseen By Michele Staton, MSW, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michele Staton

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

Compensation: Varies

Number of Visits: 1

900 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, to increase MOUD initiation and maintenance in the community following jail release. This trial will focus on incarcerated women in 6 experimental and 3 control sites in Kentucky. Enrollment is not open to the general public.

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.

What data supports the effectiveness of the treatment MOUD Pre-Treatment Telehealth for Opioid Use Disorder?

Research shows that using telehealth for opioid use disorder treatment can help keep patients engaged in their medication programs, like buprenorphine, and reduce the risk of stopping treatment. Telehealth also makes it easier for patients to access counseling and other support services, which can be challenging to attend in person. ^{1 2 3 4 5}

Is the MOUD Pre-Treatment + Telehealth approach safe for humans?

The use of telehealth for delivering medication-assisted treatment for opioid use disorder (MOUD) has been generally well-received, with benefits such as easier access to care and reduced stigma. However, some challenges include decreased access to basic resources like food and clothing, which were previously available at clinics. ^{1 3 5 6 7}

How is the MOUD Pre-Treatment + Telehealth for Opioid Use Disorder treatment different from other treatments?

This treatment is unique because it combines telehealth (remote healthcare services) with medication for opioid use disorder (MOUD) and includes a peer navigator, which is a person who has experienced similar challenges and can provide guidance and support. This approach aims to increase access to care and support through virtual means, making it more convenient and potentially more engaging for patients. ^{1 3 6 8 9}

Research Team

Michele Staton, MSW, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telehealth-Based Delivery of Medication-Assisted Treatment for Opioid Use Disorder: a Critical Review of Recent Developments. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Use of a Telemedicine Bridge Clinic to Engage Patients in Opioid Use Disorder Treatment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Youth OUD treatment during and after COVID: Increasing family involvement across the services continuum. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The provision of counseling to patients receiving medications for opioid use disorder: Telehealth innovations and challenges in the age of COVID-19. [2020]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Lessons from the First Wave of COVID-19 for Improved Medications for Opioid Use Disorder (MOUD) Treatment: Benefits of Easier Access, Extended Take Homes, and New Delivery Modalities. [2022]

8. England pubmed.ncbi.nlm.nih.gov

E-consultation for medications to treat opioid use disorders: a pilot study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. [2023]