Digital Treatment for Opioid Use Disorder

Not yet recruiting at 3 trial locations
RR
Overseen ByR. Ross MacLean, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: VA Office of Research and Development
Must be taking: Buprenorphine
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital treatment designed to assist veterans with both opioid use disorder (OUD) and chronic pain. The goal is to determine if this online program, Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), can manage pain and addiction more effectively than regular care. Participants will either use the digital program or continue with their standard treatment. Veterans suitable for the trial have been diagnosed with OUD, receive stable doses of buprenorphine, and experience bothersome musculoskeletal pain. They must also have a device with internet access to participate in study activities from home. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of buprenorphine for at least two weeks before participating.

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

Research shows that the digital treatment Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is being tested for safety and effectiveness. IMPACT combines two proven digital cognitive behavioral therapy (CBT) programs. Previous studies have examined patient responses to these digital therapies.

Results suggest that digital CBT is generally well-tolerated, meaning most people can use it without issues. There have been no significant reports of harmful side effects for similar digital treatments. While the treatment is still under study, this type of therapy has been safely used in other contexts.

Since this trial is in a late phase, earlier studies have already demonstrated the treatment's safety for continued testing. This is a positive sign that the treatment could be safe for participants.12345

Why do researchers think this study treatment might be promising for opioid use disorder?

Researchers are excited about the IMPACT digital treatment for opioid use disorder because it offers a novel approach by integrating pain and addiction management through a collaborative digital platform. Unlike traditional treatments that often rely on medications like methadone or buprenorphine, IMPACT provides a structured digital intervention tailored specifically for veterans, allowing for personalized care without the need for in-person visits. This method not only aims to improve accessibility but also seeks to enhance long-term recovery outcomes by addressing both pain and addiction simultaneously.

What evidence suggests that this digital treatment is effective for opioid use disorder?

Research has shown that the IMPACT program, a treatment in this trial, can help people manage chronic pain and opioid use disorder (OUD). This online treatment enables patients to address their pain and addiction from home. Studies indicate that digital programs like IMPACT can help patients control their symptoms, potentially reducing pain and improving addiction management. The goal is to enhance daily life and facilitate continued treatment. Participants in this trial may be randomized to receive either the IMPACT program or Enhanced Treatment as Usual (ETAU), which does not include access to IMPACT.12678

Who Is on the Research Team?

RR

R. Ross MacLean, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veterans with opioid use disorder and chronic pain who are currently on a stable dose of buprenorphine. Participants must have access to the internet, be able to walk at least one block, and have their condition documented in the VHA electronic health record.

Inclusion Criteria

I have been diagnosed with opioid use disorder in my health record.
I experience significant musculoskeletal pain.
I can access the internet daily for surveys and treatment updates.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IMPACT digital intervention for chronic pain and OUD over a 9-week period, supplemented with daily digital surveys and personalized weekly feedback messages.

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures assessed at 3 months post-randomization.

3 months

Extended Follow-up

Additional monitoring of participants for outcomes such as pain interference and sleep disturbance at 6 and 9 months post-randomization.

6-9 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Treatment as Usual (ETAU)
  • Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)

Trial Overview

The study tests an evidence-based digital treatment program called IMPACT that addresses both chronic pain and addiction. It compares this with Enhanced Treatment as Usual (ETAU) to see if it can improve care for Veterans without needing specialized clinicians at every facility.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: IMPACTExperimental Treatment1 Intervention
Group II: ETAUPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Efficacy of Integrating the Management of Pain and Addiction ...

Digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38506917/

Efficacy of Integrating the Management of Pain and Addiction ...

This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital ...

Digital Treatment for Chronic Pain and Addiction in ...

The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital ...

Expert providers implement integrated and coordinated ...

Enhancing care integration and coordination to improve patient outcomes in opioid use disorder treatment is a growing focus in the field.

Study Protocol for the Healing Opioid Misuse and Pain ...

An integrated behavioral treatment is needed to address chronic pain and opioid use disorder. •. Adaptations may be needed to implement the ...

A randomized clinical trial of a digital cognitive behavioral ...

Integrating the Management of Pain and Addiction via Collaborative Treatment ... The Impact of Chronic Pain on Opioid Use Disorder Treatment Outcomes. March ...

Collaborative care in the treatment of opioid use disorder ...

An integrated approach to OUD and other coexisting mental health disorders facilitates treatment for the patients most at risk for poor outcomes. Funding source.

Connecting Chronic Pain and Opioid Use Disorder Clinical ...

The IDEA-CC will create a research community and data commons that connect NIH HEAL IMPOWR centers to translate findings and develop a key CP-OUD research data.