Psychosocial Pain Management for Opioid Use Disorder

(Persist Trial)

No longer recruiting at 1 trial location

Overseen By Mandy Lewis, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Buprenorphine

Disqualifiers: Pregnancy, Living outside US, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how educational and therapy sessions can assist individuals in managing chronic pain while on medication for opioid use disorder. Participants will either receive usual care with two educational phone sessions or engage in a new approach involving eight therapy sessions using Cognitive Behavioral Therapy (a type of talk therapy). The trial seeks individuals diagnosed with opioid use disorder in the past year, who began buprenorphine treatment in the last six months, and have experienced moderate or greater pain for at least three months. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves people who have recently started buprenorphine treatment, you will likely need to continue with that medication.

What prior data suggests that these programs are safe for managing chronic pain and medication treatment?

Research shows that psychosocial pain management is generally safe for people with chronic pain and opioid use disorder. Studies have found that Cognitive Behavioral Therapy (CBT), a key component of this treatment, safely improves pain and enhances functioning.

These studies have reported no major side effects. In fact, CBT has been safely used to manage both pain and substance use disorders, with no serious problems occurring during therapy sessions.

Overall, psychosocial pain management appears well-tolerated, and existing research supports its safety for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Psychosocial Pain Management for Opioid Use Disorder because it offers a fresh approach compared to traditional methods. Unlike standard treatments that often rely on medication-assisted therapy, this method uses Cognitive Behavioral Therapy (CBT) through individual telephone or video sessions. This innovative delivery method focuses on tackling both pain and opioid use disorders simultaneously, potentially reducing reliance on medications. Moreover, the accessibility and convenience of remote therapy could make it a game-changer for individuals who lack easy access to in-person care.

What evidence suggests that this trial's treatments could be effective for managing chronic pain in individuals with opioid use disorder?

Earlier studies have shown that managing pain through psychological and social support holds promise for individuals with long-term pain and opioid addiction. This trial will compare two approaches: Enhanced Usual Care (EUC) and Psychosocial Pain Management (PPMI). Research indicates that these methods can improve adherence to medication plans. Participants have reported that therapy sessions make pain less disruptive in daily life. Cognitive Behavioral Therapy (CBT), included in the PPMI program, has effectively reduced pain and improved mental health. Overall, combining pain management with psychological support may lead to better treatment outcomes for those with opioid addiction. ^{2 5 6 7 8}

Who Is on the Research Team?

Mark Ilgen, Ph.D.

Principal Investigator

University of Michigan

Allison Lin, M.D., M.S.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with opioid use disorder in the last year, started buprenorphine treatment within the past six months, and suffer from moderate to severe chronic pain. Participants must have regular phone access for study sessions. Pregnant individuals or those living outside the US cannot participate.

Inclusion Criteria

I have experienced moderate to severe pain on average over the last 3 months.

You have started taking buprenorphine in the last 6 months.

You have been diagnosed with opioid use disorder in the last 12 months.

Exclusion Criteria

I am prescribed buprenorphine as a monthly shot or skin patch.

Self-reported pregnancy at the time of study enrollment

Currently living outside of the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Enhanced Usual Care or Psychosocial Pain Management sessions

8 weeks

2 visits (telephone) for EUC, 8 visits (telephone or video) for PPMI

Follow-up

Participants are monitored for substance use, pain-related functioning, and retention on buprenorphine treatment

12 months

Follow-ups at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Psychosocial Pain Management

Trial Overview The study compares two approaches: Psychosocial Pain Management (PPMI), which includes education and strategies for managing pain and medication, versus Enhanced Usual Care (EUC) that participants currently receive. The goal is to see if PPMI can improve outcomes for those on buprenorphine therapy.

How Is the Trial Designed?

Group I: Psychosocial Pain Management (PPMI) Experimental Treatment 1 Intervention

Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Two individual telephone educational sessions with research study therapist.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40972890/

The psychosocial pain management to improve opioid use ... The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04433975

Psychosocial Pain Management to Improve Opioid Use ... The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7391182/

Efficacy of a Psychosocial Pain Management Intervention ... This randomized clinical trial examines the efficacy of a behavioral pain management intervention for men and women with substance use disorders.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352250X25000168

Psychological treatments for comorbid chronic pain and ... This article reviewed psychological treatment approaches for comorbid chronic pain and opioid use disorder.

5. researchprotocols.org researchprotocols.org/2024/1/e54342

Efficacy of Integrating the Management of Pain and ... The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04433975

Psychosocial Pain Management to Improve Opioid Use ... The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... MBT and CBT were associated with safe improvements in pain and functional outcomes among adults affected with refractory, complex, opioid- ...

8. paloaltou.edu paloaltou.edu/resources/business-of-practice-blog/dbt-vs-cbt-for-chronic-pain-hybrid-protocols-and-opioid-reduction-outcomes

DBT vs CBT for Chronic Pain: Hybrid Protocols and Opioid ... Many clients with chronic pain rely on long-term opioid therapy, which can lead to dependence, reduced effectiveness, and increased risk of overdose.