378 Participants Needed

Pain Self-Management for Opioid Use Disorder

(TREETOP Trial)

Recruiting at 8 trial locations
EW
MS
Overseen ByMelessa Salay, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain opioid treatments like buprenorphine, methadone, or naltrexone for more than 7 days in the past 90 days, you cannot participate.

What data supports the effectiveness of the treatment Pain Self-Management for Opioid Use Disorder?

Research shows that an online pain self-management program can improve pain in adults undergoing treatment for opioid use disorder. Additionally, integrated pain management treatments have led to significant improvements in pain, emotional distress, and medication reduction for individuals with both chronic pain and substance use disorders.12345

Is Pain Self-Management safe for humans?

The research does not provide specific safety data for Pain Self-Management, but it highlights the importance of proper candidate selection and monitoring when using opioids for chronic pain, as there are risks of misuse and addiction.46789

How is the Pain Self-Management treatment different from other treatments for opioid use disorder?

Pain Self-Management is unique because it focuses on helping individuals manage their pain without relying solely on medications, which is important for those with opioid use disorder who are at risk of relapse. This approach may include online programs and interdisciplinary care, offering a more holistic and personalized way to address pain compared to traditional pharmaceutical methods.13101112

What is the purpose of this trial?

The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are:* Does PSM help participants manage their chronic pain more effectively?* Does PSM help participants engage in treatment for opioid use?Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.Participants will:* Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study* Complete surveys every 3 months for 9 months (total of 4 visits)Participants will receive compensation for participating in the study.There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.

Research Team

EW

Erin Winstanley, PhD

Principal Investigator

University of Pittsburgh

JM

Jessica Merlin, MD, PhD, MBA

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with chronic pain who also misuse opioids or have an opioid use disorder. They should be willing to engage in a Pain Self-Management program or receive standard care and complete surveys over 9 months.

Inclusion Criteria

Access to phone and/or internet
Current or new primary care patient at a participating clinic
Must meet criteria for OUD or opioid misuse based on specific criteria
See 3 more

Exclusion Criteria

I experience pain due to my cancer.
Currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action
Had an intentional suicide attempt within the past 3 months
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Pain Self-Management (PSM) program or receive standard care for 12 weeks

12 weeks
10 sessions (phone or web-based)

Follow-up

Participants complete surveys every 3 months for 9 months to monitor engagement and pain management

9 months
4 visits (survey completion)

Treatment Details

Interventions

  • Pain Self-Management
Trial Overview The study tests if Pain Self-Management (PSM) can better manage chronic pain and improve treatment engagement compared to usual care for those with opioid misuse issues. Participants will follow the assigned intervention for 12 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain Self-Management (PSM)Experimental Treatment1 Intervention
PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.
Group II: Usual CareActive Control1 Intervention
Usual care refers to the standard of care that patients receive at their primary care clinic.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

In a pilot study involving 60 adults with chronic pain and opioid use disorder, participants who used an online pain self-management program reported significant reductions in pain interference, pain severity, opioid misuse, and depressive symptoms after 8 weeks.
The study highlights that a majority of participants initially used opioids due to pain, indicating that effective pain management strategies like this online program could be crucial in addressing both pain and opioid misuse.
Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders.Wilson, M., Finlay, M., Orr, M., et al.[2019]
A study involving 44 patients with chronic pain and substance abuse disorders showed significant improvements in pain management, emotional distress, and medication use after a 10-week outpatient treatment program.
At the 12-month follow-up, half of the participants were opioid-free, indicating that an integrated treatment model can effectively address both pain and substance use issues in this population.
Outcome from integrated pain management treatment for recovering substance abusers.Currie, SR., Hodgins, DC., Crabtree, A., et al.[2019]
Chronic pain is reported by 33.4% of individuals entering opioid use disorder (OUD) treatment programs, but 66% of those with chronic pain do not have their pain managed within these programs, leading to worsening pain for 47% of them.
The lack of effective pain management in OUD treatment is linked to a higher risk of opioid relapse, highlighting the need for interdisciplinary care and evidence-based policies to improve pain management and treatment outcomes for OUD patients.
Assessment of Chronic Pain Management in the Treatment of Opioid Use Disorder: Gaps in Care and Implications for Treatment Outcomes.Ellis, MS., Kasper, Z., Cicero, T.[2021]

References

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. [2019]
Outcome from integrated pain management treatment for recovering substance abusers. [2019]
Assessment of Chronic Pain Management in the Treatment of Opioid Use Disorder: Gaps in Care and Implications for Treatment Outcomes. [2021]
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]
Patient Motivation to Reduce or Discontinue Opioids for Chronic Pain: Self-efficacy, Barriers, and Readiness to Change. [2023]
Iatrogenic opioid use disorder, chronic pain and psychiatric comorbidity: A systematic review. [2020]
Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial. [2023]
Risk Factors for Opioid-Use Disorder and Overdose. [2018]
Acute pain and self-directed discharge among hospitalized patients with opioid-related diagnoses: a cohort study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Managing Cancer Pain in Patients with Opioid and Substance Use Disorders. [2020]
Challenges in using opioids to treat pain in persons with substance use disorders. [2021]
Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. [2023]
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