Telemedicine-Based Pain Management for Opioid Use Disorder

Not currently recruiting at 3 trial locations

Overseen By Maria Zenoni, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Not engaged in TCM

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain for individuals with opioid use disorder (OUD) using telemedicine. It compares two approaches: one involves clinical pharmacists providing care (Telemedicine and Collaborative Management, or TCM), and the other adds extra support through pain education and self-management (Telemedicine and Collaborative Management plus Cooperative Pain Education and Self-Management, or TCM plus COPES). The researchers seek to determine which method more effectively reduces pain and opioid misuse. Individuals already using the TCM program, with or without the additional COPES support, are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies through telemedicine.

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 doctor.

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

Research has shown that telemedicine and collaborative management (TCM) for treating opioid use disorder are generally well-received by patients. Studies have found telehealth, which involves receiving healthcare services remotely, to be safe for many dealing with opioid issues. For instance, one study examined telehealth for chronic pain and substance use and found it effective for city-dwelling patients.

Limited information exists about combining TCM with the COPES program. However, this combination aims to improve pain management and reduce opioid use. Both methods focus on patient needs and aim to lower opioid use safely.

This trial is in the "Not Applicable" phase, indicating that specific safety data for TCM plus COPES might not be available yet. This phase usually means the treatment is still under study, but past safety results from similar telemedicine setups provide some reassurance. Overall, early findings suggest these treatments might be safe, but further research will offer a clearer picture. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telemedicine-Based Pain Management approach for opioid use disorder because it offers a fresh take on treatment by leveraging telemedicine and clinical pharmacist-led interventions. Unlike traditional methods that heavily rely on in-person visits and long-term opioid therapy (LTOT), this approach uses telemedicine to facilitate remote reassessment of LTOT and, when necessary, initiates buprenorphine treatment with the convenience of virtual consultations. The addition of COPES alongside TCM further enhances this model by providing support and augmenting the effectiveness of the core treatment. This innovative use of technology and pharmacist-led care aims to make treatment more accessible and tailored, potentially transforming how opioid use disorder is managed.

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

Research has shown that telemedicine and team-based care can safely manage opioid use disorder (OUD). In this trial, participants in the TCM arm will receive telemedicine treatment for OUD, which has demonstrated similar results to in-person care, maintaining steady rates of treatment retention. Participants in the TCM plus COPES arm will receive an enhanced treatment that includes the Cooperative Pain Education and Self-Management (COPES) program. This program, which incorporates cognitive behavioral therapy, may further assist patients in managing long-term pain. Digital treatments for pain and OUD have shown promise in improving patient outcomes. Overall, these methods aim to reduce the need for high-dose opioid treatments while effectively managing pain. ^{3 6 7 8 9}

Who Is on the Research Team?

William Becker, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Pain CHAMP is for individuals with opioid use disorder or opioid abuse who are engaged in telemedicine and collaborative management (TCM) at a participating study site. Providers involved with these sites can also participate. Those not engaged in TCM or connected to a study site cannot join.

Inclusion Criteria

You are currently involved with a study site that is participating in the clinical trial.

I am currently receiving traditional Chinese medicine treatments.

I am currently participating in a traditional Chinese medicine program.

Exclusion Criteria

Providers not engaged with a participating study site

I am not currently participating in any traditional Chinese medicine treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Telemedicine Collaborative Management (TCM) or TCM plus Cooperative Pain Education and Self-Management (COPES) interventions

16 weeks

Virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

Implementation Facilitation

Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on RE-AIM guided outcomes

30 months

What Are the Treatments Tested in This Trial?

Interventions

• TCM
• TCM plus COPES

Trial Overview

The trial compares two approaches: one group receives standard TCM, while the other gets TCM plus an additional program called Cooperative Pain Education and Self-Management (COPES). The goal is to see which method better reduces pain interference and symptoms of opioid misuse.

How Is the Trial Designed?

Group I: TCM plus COPES Experimental Treatment 1 Intervention

Participants in this arm will use TCM plus COPES that will augment the effectiveness of TCM alone.

Group II: TCM Active Control 1 Intervention

TCM uses clinical pharmacists leading LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Clinical pharmacists will lead LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician.

TCM is already approved in United States for the following indications:

Approved in United States as TCM for:

• Chronic Pain Management
• Opioid Use Disorder/Misuse Symptoms

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Chronic opioid therapy (COT) for chronic noncancer pain can be safe and effective when healthcare providers are skilled in opioid prescribing and risk management related to abuse and addiction, as highlighted by a systematic review and expert panel recommendations.

Key recommendations include careful patient selection, risk stratification, informed consent, and ongoing monitoring to manage potential adverse effects and ensure safe use, especially in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2009 Clinical Guidelines from the American Pain Society and the American Academy of Pain Medicine on the use of chronic opioid therapy in chronic noncancer pain: what are the key messages for clinical practice? Chou, R.[2018]

Telemedicine (TM) has been rapidly adopted to provide medication treatment for opioid use disorder (MOUD) in rural areas, especially during the COVID-19 pandemic, to improve access to care.

A feasibility study for a larger trial revealed significant challenges in implementing TM-based MOUD, including low identification and referral rates for opioid use disorder, access to digital devices, and insurance coverage issues, highlighting the need for better guidance on effective TM practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial. Hser, YI., Ober, AJ., Dopp, AR., et al.[2021]

A study involving 22 health centers across 14 states found that 8 of them offered telemedicine services for opioid use disorder (Tele-OUD), primarily providing medication management through video consultations after an initial in-person visit.

Barriers to adopting Tele-OUD included strict regulations on prescribing controlled substances like buprenorphine and challenges in coordinating lab results, highlighting the need for policy changes to enhance telemedicine's role in treating opioid use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health center implementation of telemedicine for opioid use disorders: A qualitative assessment of adopters and nonadopters. Uscher-Pines, L., Raja, P., Mehrotra, A., et al.[2023]

The study demonstrated that a care coordination model for telemedicine-delivered medication treatment for opioid use disorder (MOUD) was feasible in 6 rural clinics, with an overall referral rate of 11.7% among patients.

Five out of the six clinics experienced an increase in patient-days on MOUD during the intervention, particularly in those with limited MOUD capacity, suggesting that telemedicine can effectively expand access to treatment in underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care coordination between rural primary care and telemedicine to expand medication treatment for opioid use disorder: Results from a single-arm, multisite feasibility study. Hser, YI., Mooney, LJ., Baldwin, LM., et al.[2023]

In a study of over 41,000 individuals receiving buprenorphine for opioid use disorder during the COVID-19 pandemic, telemedicine initiation of treatment was linked to better retention rates in both Kentucky and Ohio, suggesting it is an effective method for maintaining treatment.

Telemedicine initiation did not increase the risk of opioid-related nonfatal overdoses, indicating that this approach is safe for patients starting buprenorphine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine Buprenorphine Initiation and Retention in Opioid Use Disorder Treatment for Medicaid Enrollees. Hammerslag, LR., Mack, A., Chandler, RK., et al.[2023]

The percentage of opioid use disorder (OUD) visits conducted via telemedicine decreased from 56.9% in December 2020 to 41.5% by March 2022, but clinicians preferred telemedicine to account for 34.8% of visits post-pandemic, indicating a shift in practice preferences.

Despite some discomfort with telemedicine for certain patient types, 70.9% of clinicians reported that most of their patients preferred telemedicine, and 76.7% believed it helped patients stay in treatment longer, highlighting its perceived benefits for patient retention and clinician well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Prospects for Telemedicine in Opioid Use Disorder (OUD) Treatment: Results from a Longitudinal Survey of OUD Clinicians. Huskamp, HA., Riedel, L., Campa, I., et al.[2023]

Traditional Chinese medicine (TCM), including acupuncture and herbal treatments, has shown significant efficacy in managing chronic pain, supported by large meta-analyses involving thousands of patients.

TCM offers a non-addictive alternative to opioids for pain management, which is crucial given the opioid crisis in the U.S., and opinion leaders advocate for its integration into treatment strategies to avoid the dangerous side effects associated with opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can eastern wisdom resolve western epidemics? Traditional Chinese medicine therapies and the opioid crisis. Efferth, T., Xu, AL., Damiescu, R., et al.[2021]

A novel educational session on complementary and alternative medicine (CAM) for chronic pain management significantly increased second-year medical students' knowledge and understanding of CAM practices, as evidenced by matched pre- and post-session surveys involving 345 participants.

Students also reported a greater appreciation for the importance of physician familiarity with CAM practices and their associated costs, highlighting the session's effectiveness in enhancing awareness and understanding of nonpharmacologic treatment options in the context of the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Interactive Introduction to Complementary Medicine for Chronic Pain Management Into the Medical School Curriculum. Gadde, U., Matthew, P., Kumar, R., et al.[2023]

A pilot study involving 152 military health system beneficiaries demonstrated that an app-based pain education program was feasible and well-received, with 73% of participants finding the videos helpful.

The study suggests that providing tablet-based pain management education in various clinic settings, not just specialty pain clinics, can enhance patient understanding and discussions about pain management and opioid safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Pain Management and Opioid Education Program for Patients in Clinic Waiting Rooms. Highland, KB., Giordano, NA., Kirk, K., et al.[2021]

A web-based self-management intervention based on cognitive behavior therapy significantly reduced aberrant drug-related behavior and pain catastrophizing in chronic pain patients at risk for opioid misuse, compared to standard treatment alone, in a study of 110 participants over 12 weeks.

The intervention also led to fewer pain-related emergency department visits, indicating its potential effectiveness in improving the management of chronic pain and reducing risky behaviors associated with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial. Guarino, H., Fong, C., Marsch, LA., et al.[2023]

The Pain E-Consult Program (PEP) led to a significant reduction in opioid use among patients, with a median decrease of 7.4 mg/day at 6 months and 15.1 mg/day at 12 months compared to usual care.

Patients in the PEP group were more likely to achieve a ≥20% decrease in opioid dosage, with 41.6% at 6 months and 48.0% at 12 months, indicating the program's effectiveness in managing pain without increasing nonopioid medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of an Outpatient Multidisciplinary Chronic Pain Management Telementoring Service. Gersch, WD., Delate, T., Bergquist, KM., et al.[2023]

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]

The scoping review identified 40 distinct telemedicine-mediated opioid use disorder (TMOUD) services, primarily in the US, highlighting the growing role of telemedicine in providing medications like buprenorphine and methadone during and after the COVID-19 pandemic.

Four models of TMOUD care were established, focusing on inclusion health, transitions in care, addressing complex healthcare needs, and ensuring resilience in opioid use disorder services, which can inform future policy and practice in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the use of telemedicine across different opioid use disorder treatment models: A scoping review. Tay Wee Teck, J., Butner, JL., Baldacchino, A.[2023]

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These findings suggest that adding app-based contingency management to MOUD is associated with better treatment outcomes in clinical settings.

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Pain Care at Home to Amplify Function (Pain CHAMP)

This project aims to test simultaneously the effectiveness of telemedicine and collaborative management (TCM) vs. TCM plus Cooperative Pain Education and ...

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