Customized Screening for Opioid Use Disorder and Chronic Pain

(OPTIC Trial)

Recruiting at 2 trial locations

Overseen By Angel R Vasquez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Psychiatric, cognitive, medical conditions, others

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

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively clinics can implement special screening and brief interventions tailored to American Indian and Alaska Native cultures for individuals dealing with chronic pain and opioid issues. Researchers seek to understand clinic staff perspectives on these new methods and gain insights into the patients they serve. The trial involves applying these implementation strategies in practice and observing their effectiveness. Individuals who receive services at participating clinics, experience ongoing pain, or struggle with opioid use, and identify as American Indian or Alaska Native, might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored healthcare improvements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these implementation strategies are safe for use in clinics?

Research shows that many methods for managing opioid use and chronic pain are generally safe. Studies have examined various strategies, such as altering clinic prescribing practices and providing education on overdose prevention. These approaches do not involve new medications or risky procedures but instead focus on enhancing existing clinical practices.

For example, some methods include educating individuals on preventing overdoses and using opioids safely when necessary. This approach reduces harm without introducing new risks. Evidence suggests these methods are well-tolerated, with no significant reports of negative effects. They primarily aim to make current practices safer and more effective.

Overall, the safety data is promising, as these strategies aim to improve current care without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new strategies for addressing opioid use disorder and chronic pain through customized clinic protocols. Unlike traditional treatments that typically focus on medication management or standardized therapy programs, this trial aims to implement evidence-based strategies tailored specifically to each clinic's goals. By emphasizing a collaborative approach where clinics set their own targets, there's potential for more sustainable and effective outcomes. This method could significantly enhance how clinics maintain and achieve their implementation goals over time, offering a fresh perspective on managing these challenging conditions.

What evidence suggests that these implementation strategies are effective for opioid use disorder and chronic pain?

Research has shown that culturally tailored methods in clinics can more effectively manage opioid misuse and chronic pain. This trial will implement evidence-based strategies to achieve these goals. For instance, teams of healthcare professionals collaborating and educational programs for patients have shown promise in managing these issues. These methods aim to reduce opioid misuse and improve pain management by focusing on personalized care. While using opioids alone for long-term pain lacks proven effectiveness, combining them with these tailored approaches may yield better results. Overall, these strategies are designed to improve patient outcomes by addressing both opioid misuse and pain management needs. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew R Pearson, PhD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

The OPTIC trial is for individuals in American Indian and Alaska Native communities who are dealing with chronic pain and opioid misuse or disorder. It's focused on improving screening and intervention methods that are culturally tailored to these communities.

Inclusion Criteria

Willing and able to provide informed consent

Have English comprehension and proficiency

Receiving services at one of our participating study sites

Exclusion Criteria

Presence of a psychiatric, cognitive, or medical condition that interferes with the consenting process

Timeline for a Trial Participant

Pre-Intervention

Baseline prior to any involvement with the project

Not specified

Intervention

A workgroup for each clinic meets to select specific goals for the clinic to be targeted during the implementation phase

6 months

Implementation

Evidence-based implementation strategies are put into practice

6 months

Follow-up

Participants are monitored for the sustainment of implementation phase goals

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Strategies

Trial Overview This study tests the process of implementing strategies specifically designed for AI/AN clinics to better address chronic pain and opioid misuse. It includes gathering feedback from clinic staff as well as surveying patients affected by these issues.

How Is the Trial Designed?

Group I: Sustainment Active Control 1 Intervention

Measuring the degree to which the clinic maintains the implementation phase goals.

Group II: Implementation Active Control 1 Intervention

Evidence-based implementation strategies are put into practice for approximately 6 months.

Group III: Pre-Intervention Active Control 1 Intervention

Baseline prior to any involvement with the project

Group IV: Intervention Active Control 1 Intervention

A workgroup for each clinic meets for approximately 6 months to select the specific goals for the clinic to be targeted during the implementation phase.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Long-term opioid therapy for chronic pain presents significant challenges, including potential safety issues like overdose and inadequate pain relief, highlighting the need for careful management.

The authors propose a research agenda focused on improving opioid prescribing practices, which includes developing patient-reported measures for safety and efficacy, creating evidence-based treatment algorithms, and promoting multi-modal treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A research agenda for enhancing appropriate opioid prescribing in primary care. Becker, WC., Fraenkel, L., Kerns, RD., 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]

Chronic pain patients with substance use or mental health disorders are at a higher risk for misusing prescribed opioids, highlighting the need for effective treatment strategies that manage pain while minimizing abuse risks.

Currently, there is no single reliable screening tool to predict which patients are unsuitable for opioid therapy, necessitating a combination of strategies, including risk assessment and monitoring, to effectively manage opioid use and prevent addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. Sehgal, N., Manchikanti, L., Smith, HS.[2022]

A study involving 753 patients over 24 months found that those with suspected adverse drug reactions (ADRs) experienced significantly higher pain intensity and more adverse events compared to controls, indicating a need for careful monitoring in chronic non-cancer pain management.

The pharmacovigilance data recording system improved the management of pain therapy, leading to better patient health outcomes and potentially reducing healthcare costs, as it identified previously unknown ADRs and highlighted the risks associated with polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of an adverse events reporting system for chronic pain patients using long-term opioids. Planelles, B., Margarit, C., Ajo, R., et al.[2020]

Chronic pain management with opioids has significantly increased over the past 20 years, leading to a rise in opioid abuse and accidental overdoses, highlighting the urgent need for effective screening and monitoring strategies.

Current screening methods, while varied, lack a single reliable tool to predict which patients are at risk for opioid misuse, emphasizing the importance of a comprehensive approach that includes risk stratification, urine drug testing, and monitoring programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Opioid Abuse in Chronic Pain: An Updated Review of Opioid Abuse Predictors and Strategies to Curb Opioid Abuse (Part 2). Kaye, AD., Jones, MR., Kaye, AM., et al.[2022]

Chronic pain management with opioids has significantly increased over the past 20 years, leading to a rise in opioid abuse and accidental overdoses, highlighting the urgent need for effective screening tools to identify patients at risk for misuse.

Current strategies for assessing opioid abuse risk include evaluating personal and family history of substance abuse, monitoring drug-related behaviors, and using various screening instruments, but no single tool has proven fully reliable, necessitating a combination of approaches for effective risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Opioid Abuse in Chronic Pain: An Updated Review of Opioid Abuse Predictors and Strategies to Curb Opioid Abuse: Part 1. Kaye, AD., Jones, MR., Kaye, AM., et al.[2022]

This systematic review analyzed 16 randomized trials and 8 observational studies involving 1427 and 1190 patients, respectively, to evaluate the efficacy and safety of long-acting opioids for chronic non-cancer pain.

The review found insufficient evidence to conclude that different long-acting opioids have distinct efficacy or safety profiles compared to each other or to short-acting opioids, although some evidence suggested that long-acting and short-acting oxycodone are equally effective for pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. Chou, R., Clark, E., Helfand, M.[2022]

In a study of 78 patients over six years at the High-Risk Pain Clinic, buprenorphine/naloxone was found to significantly reduce pain scores, indicating its efficacy in managing chronic pain for patients with a history of substance use disorder.

The clinic had a retention rate of 41%, suggesting that while many patients continued treatment, there is still a notable number who may not stay engaged in this multimodal approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. Kaski, S., Marshalek, P., Herschler, J., et al.[2021]

A study of over 403,000 adults aged 65 and older found that the use of low- and intermediate-potency opioids is associated with an increased risk of injury, with low-potency opioids having a hazard ratio of 1.36.

Codeine combinations posed the highest risk, showing a 127% greater risk of injury per dose increase, highlighting the need for caution when prescribing these medications to older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of injury associated with opioid use in older adults. Buckeridge, D., Huang, A., Hanley, J., et al.[2022]

Screening tests are essential for predicting aberrant opioid use in chronic pain treatment, but their effectiveness can be influenced by the prevalence of opioid misuse, making interpretation challenging.

The article emphasizes the need for clear clinical guidelines on the use of these screeners, focusing on understanding sensitivity, specificity, and predictive value to improve decision-making in opioid management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Screening Tests to Predict Aberrant Use of Opioids in Chronic Pain Patients: Caveat Emptor. Bailey, RW., Vowles, KE.[2022]

A new screening tool for addiction in chronic pain patients was tested on a small group of 52 individuals, showing significant differences in responses between those with and without substance use disorders.

The study identified three key indicators from the screening questionnaire that effectively predicted the presence of addiction, suggesting the tool could improve the assessment of addiction risk in patients receiving chronic opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for addiction in patients with chronic pain and "problematic" substance use: evaluation of a pilot assessment tool. Compton, P., Darakjian, J., Miotto, K.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK458653/

Evidence on Strategies for Addressing the Opioid Epidemic The purpose of this chapter is to review available evidence on strategies that have been used to address the problems of opioid misuse, OUD, and related deaths.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590020300900

Assessment of Chronic Pain Management in the Treatment ... This article suggests chronic pain is commonly reported, yet not managed by many OUD treatment programs, increasing the likelihood of opioid relapse.

3. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.

4. acpjournals.org acpjournals.org/doi/10.7326/M14-2559

The Effectiveness and Risks of Long-Term Opioid Therapy ... Evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.

5. nam.edu nam.edu/product/research-data-and-metrics-working-group-research-agenda/

Research, Data, and Metrics Working Group ... Potential areas of focus should include the use of interdisciplinary pain management teams, developing and implementing pain education programs for patients and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000598

Do communities implementing the CTH intervention have ... Implementation of the CTH intervention did not result in statistically significant differences in the rate of safer opioid prescribing, ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824679

Strategies to Deimplement Opioid Prescribing in Primary ... Providing clinic- and prescriber-level deimplementation strategies may help health systems take positive steps toward reducing reliance on opioid medications.

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230918

Harm Reduction for Opioid Use Disorder: Strategies and ... Strategies designed to reduce opioid-related harms include syringe exchange programs, overdose education and naloxone distribution, supervised consumption ...