Screening for Opioid Misuse Prevention

(STOMP-AI Trial)

Recruiting at 1 trial location

Overseen By Ejura Salihu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Suboxone, Buprenorphine, Methadone, Naltrexone

Disqualifiers: Cancer, Dementia, Traumatic brain injury, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

107 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the present pilot, sequential, multiple-assignment randomized trial (Pilot SMART) is to determine feasibility and acceptability of delivering (from the perspective of the treatment/intervention staff) and receiving (from the perspective of the patient) an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury. A complimentary secondary objective is to ensure the feasibility of conducting a future, multi-site, full-scale SMART. Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently prescribed medication for opioid use disorder, you may not be eligible to participate.

What data supports the effectiveness of the treatment Enhanced Trauma Care Coordination (eTCC) and Pain Coping Skills Training (PCST) for preventing opioid misuse?

Research shows that Pain Coping Skills Training (PCST) is effective in reducing pain and improving outcomes for patients with cancer and osteoarthritis. This suggests that PCST could be beneficial in managing pain and potentially reducing opioid misuse. ^{1 2 3 4 5}

Is the treatment for opioid misuse prevention safe for humans?

The treatment, which includes pain coping skills training and opioid taper support, has been tested in clinical trials and did not show an increase in pain intensity or significant adverse effects, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the Pain Coping Skills Training - Plus (PCST+) treatment different from other treatments for preventing opioid misuse?

PCST+ is unique because it focuses on teaching pain coping skills to help manage chronic pain without relying on opioids, addressing psychological factors that can increase the risk of opioid misuse. This approach is different from traditional treatments that primarily focus on medication. ^{4 10 11 12 13}

Research Team

Randy Brown, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

This trial is for English-speaking individuals hospitalized for a traumatic injury, who received or were prescribed opioids. They must be able to manage their own medications after discharge and have an injury severity score of 9 or more.

Inclusion Criteria

Admission to site hospital for a traumatic injury at time of screening (defined as a physical injury with sudden onset requiring immediate medical attention)

I will manage my own medications after leaving the hospital or rehab.

I've taken strong pain medication recently or have a prescription for it.

Exclusion Criteria

Inability to provide written consent for any reason

I have been told I may have less than 12 months to live due to cancer.

I have a history of illnesses like Alzheimer's, Parkinson's, or vascular dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of four interventions: standard Trauma Care Coordination (sTCC), sTCC + Pain Coping Skills Training (PCST-Lite), enhanced Trauma Care Coordination (eTCC), or eTCC + PCST-Lite. Re-randomization may occur at 4 weeks based on risk assessment.

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and acceptability of the intervention.

up to 6 months

Treatment Details

Interventions

• Enhanced Trauma Care Coordination (eTCC)
• Pain Coping Skills Training - Brief (PCST-LITE)
• Pain Coping Skills Training - Maintenance (PCST-M)
• Pain Coping Skills Training - Plus (PCST+)
• Standard Trauma Care Coordination (sTCC)

Trial Overview The study tests several interventions aimed at reducing opioid misuse in trauma patients: Opioid Risk Monitoring, various levels of Pain Coping Skills Training, and different intensities of Trauma Care Coordination. It's a pilot trial to see if these methods are workable and helpful.

Participant Groups

Group I: sTCC re-randomized to sTCC Experimental Treatment 2 Interventions

Participants initially randomized to sTCC who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC.

Group II: sTCC re-randomized to PCST-LITE Experimental Treatment 3 Interventions

Participants initially randomized to Standard Trauma Care Coordination (sTCC) who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC.

Group III: eTCC re-randomized to eTCC Experimental Treatment 2 Interventions

Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive the same intervention at 4 weeks.

Group IV: eTCC re-randomized to PCST-LITE Experimental Treatment 3 Interventions

Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to PCST-LITE at 4 weeks.

Group V: eTCC Low Risk eTCC Experimental Treatment 2 Interventions

Participants initially randomized to eTCC who are identified to be at low risk for opioid misuse at week 4 will continue eTCC.

Group VI: PSCT-LITE re-randomized to PCST+ Experimental Treatment 3 Interventions

Participants initially randomized to PCST-LITE who are identified to be at elevated risk for opioid misuse at week 4 re-randomized to PCST+.

Group VII: PCST-Lite Low Risk PCST-M Experimental Treatment 2 Interventions

Participants initially randomized to PCST-Lite who are identified to be at low risk for opioid misuse at week 4 will be assigned to PCST-M.

Group VIII: PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus Experimental Treatment 4 Interventions

Participants initially randomized to Pain Coping Skills Training-Lite (PCST-Lite) plus enhanced Trauma Care Coordination (eTCC) who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Enhanced Pain Coping Skills Training (PCST-Plus).

Group IX: PCST-Lite + eTCC re-randomized to eTCC + PCST-M Experimental Treatment 4 Interventions

Participants initially randomized to PCST-Lite plus eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Pain Coping Skills Training-Maintenance (PCST-M) at 4 weeks.

Group X: PCST-Lite + eTCC Low Risk eTCC + PCST-M Experimental Treatment 4 Interventions

Participants initially randomized to PCST-Lite plus eTCC who are identified to be at low risk for opioid misuse at week 4 will then receive eTCC and PCST-M.

Group XI: PCST-LITE re-randomized to PCST-Maintenance Experimental Treatment 3 Interventions

Participants initially randomized to PCST-LITE and are not re-randomized to an augmented form of PCST will instead receive PCST-Maintenance (PCST-M).

Group XII: sTCC Low Risk sTCC Active Control 2 Interventions

Participants initially randomized to sTCC who are identified to be at low risk for opioid misuse at week 4 will continued sTCC.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Wisconsin Partnership Program

Collaborator

Trials

9

Recruited

590+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Findings from Research

A brief pain coping skills training (PCST) intervention delivered via mobile health technology was found to be feasible and acceptable for 25 cancer patients, with an impressive session completion rate of 84%.

Participants experienced significant improvements in pain, physical symptoms, psychological distress, and pain catastrophizing after the intervention, suggesting that mHealth delivery can effectively enhance access to pain management resources for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. Somers, TJ., Abernethy, AP., Edmond, SN., et al.[2018]

The study involved 25 older adults with knee osteoarthritis, and those who participated in pain coping-skills training (PCST) showed significant improvements in pain self-efficacy, exercise self-efficacy, lower muscle strength, and mobility after 8 weeks.

PCST also led to an increase in moderate-to-vigorous physical activity and a decrease in reliance on medical behaviors as a coping strategy, indicating its effectiveness in enhancing overall physical function and daily activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of pain coping skills training among older outpatients with osteoarthritis]. Nagasawa, Y., Oka, K., Shibata, A.[2018]

A study involving 327 women with breast cancer showed that Pain Coping Skills Training (PCST) is effective in reducing pain, with the full 5-session program leading to a greater average pain reduction compared to the brief 1-session program.

Adjusting the dose of PCST based on patient response resulted in sustained pain relief over time, indicating that personalized pain management strategies can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral cancer pain intervention dosing: results of a Sequential Multiple Assignment Randomized Trial. Somers, TJ., Winger, JG., Fisher, HM., et al.[2023]

The HOPE social media-based support group significantly increased patient engagement, with intervention participants making nearly 10 times more posts compared to the control group (411 posts vs. 45).

This online community facilitated discussions on important topics such as coping strategies, pain management, and opioid-related issues, indicating its potential as an effective behavioral intervention for patients at risk of opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a social media/online community support group intervention among chronic pain patients on opioid therapy. Young, SD., Koussa, M., Lee, SJ., et al.[2020]

Pain coping skills training (PCST) is effective for managing pain in women with breast cancer, with a study involving 327 participants showing that a 1-session PCST protocol followed by tailored maintenance calls or sessions offers the best cost-effectiveness and quality-adjusted life-years (QALYs).

The analysis revealed that while a 5-session PCST protocol is more expensive, it provides greater QALYs compared to a 1-session protocol, suggesting that a flexible approach based on patient response can optimize both outcomes and costs in cancer pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer. Li, Y., Reed, SD., Winger, JG., et al.[2023]

A new study is testing a cognitive-behavioral therapy-based intervention that combines pain coping skills training with optional opioid taper support for patients on long-term opioid therapy, aiming to reduce opioid doses safely while managing pain.

The trial will involve 215 participants and assess outcomes like opioid dose reduction and pain interference over 12 months, building on previous findings that showed a 43% reduction in opioid dose with this approach compared to only 19% with usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Wartko, PD., Boudreau, DM., Turner, JA., et al.[2022]

A 4-week Pain Coping Strategies (PCS) program significantly improved mood, functional status, and physical ability in 31 chronic pain patients, as measured by standardized scales before and 6 weeks after the program.

The study suggests that early intervention with pain management strategies can effectively promote self-management and positive coping skills in chronic pain patients, even while they are undergoing other medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Mead, K., Theadom, A., Byron, K., et al.[2011]

The STRIPE trial, involving 153 patients on long-term opioid therapy for chronic pain, found that a structured intervention combining pain coping skills training and support for opioid tapering did not significantly reduce opioid doses or improve pain and functioning after 12 months.

Only 41% of participants completed all intervention sessions, indicating challenges in adherence, and highlighting the need for alternative strategies to effectively reduce opioid use while enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Wartko, PD., Krakauer, C., Turner, JA., et al.[2023]

In a study of 289 trauma-exposed adults with chronic pain, higher levels of perceived distress tolerance were found to reduce the risk of opioid misuse and dependence associated with posttraumatic stress symptoms.

These results suggest that addressing distress tolerance could be an important factor in developing interventions for individuals with chronic pain and a history of trauma, potentially helping to prevent opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress and distress tolerance in relation to opioid misuse and dependence among trauma-exposed adults with chronic pain. Fogle, BM., Kabel, K., Shepherd, JM., et al.[2023]

This study is testing a 2-hour skills-based pain management class against a health education class in 136 adults with chronic pain who are currently using opioids, aiming to see if the skills class can better improve pain control and reduce opioid use.

The trial hypothesizes that the skills-based intervention will enhance self-regulation of pain-specific distress and lead to a decrease in daily opioid consumption, potentially offering a cost-effective alternative to traditional opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Ziadni, MS., Chen, AL., Winslow, T., et al.[2021]

In a study of 77 patients with chronic pain, long-term opioid treatment significantly reduced both maximum and habitual pain levels over a 6-month period, improving overall quality of life.

Patients with a lower risk of opioid misuse, as indicated by psychological assessments, experienced better pain relief outcomes, highlighting the importance of psychological screening before starting opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of opioid analgesics in chronic noncancer pain. Ferrari, R., Zanolin, ME., Duse, G., et al.[2019]

In a study of 223 oncology patients, factors such as younger age, male sex, and higher depression scores were linked to a higher risk of opioid misuse, as indicated by the SOAPP-SF assessment.

An SOAPP-SF score of 3 or higher was found to predict noncompliant toxicology tests with a sensitivity of 74% and specificity of 64%, suggesting it can be a useful tool for screening opioid misuse in cancer patients, although caution is advised due to potential false positives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Risk Screening in an Oncology Palliative Medicine Clinic. Greiner, RS., Boselli, D., Patel, JN., et al.[2021]

The Opioid Risk Tool (ORT) effectively predicts the likelihood of patients developing aberrant behaviors when prescribed opioids, with a high sensitivity (90.9% for high-risk patients) and specificity (94.4% for low-risk patients) based on a study of 185 new patients monitored for 12 months.

The ORT demonstrated excellent discrimination in predicting risk across both male and female patients, suggesting it could be a valuable screening tool for clinicians to identify individuals at risk for substance abuse when managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Webster, LR., Webster, RM.[2022]

References

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

A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

[The effects of pain coping skills training among older outpatients with osteoarthritis]. [2018]

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

Behavioral cancer pain intervention dosing: results of a Sequential Multiple Assignment Randomized Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of a social media/online community support group intervention among chronic pain patients on opioid therapy. [2020]

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

Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer. [2023]

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

STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. [2022]

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

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. [2011]

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

STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. [2023]

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

Posttraumatic stress and distress tolerance in relation to opioid misuse and dependence among trauma-exposed adults with chronic pain. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. [2021]

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

Effectiveness of opioid analgesics in chronic noncancer pain. [2019]

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

Opioid Risk Screening in an Oncology Palliative Medicine Clinic. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. [2022]