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

Trial Summary

What is the purpose of this trial?

The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.

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 data supports the effectiveness of this treatment for opioid use disorder and chronic pain?

The research highlights the importance of using a combination of strategies, such as screening tools and monitoring programs, to effectively manage opioid use in patients with chronic pain. These strategies help identify patients at risk of misuse and tailor treatments to minimize the risk of addiction. ^{1 2 3 4 5}

Is the treatment for opioid use disorder and chronic pain generally safe for humans?

The research suggests that long-term opioid therapy can have safety issues, including the risk of misuse and overdose. However, a study on sublingual buprenorphine/naloxone, used in a multimodal approach, supports its safety and effectiveness in managing chronic pain in patients with a history of substance use disorder. ^{6 7 8 9 10}

How is the Customized Screening for Opioid Use Disorder and Chronic Pain treatment different from other treatments?

This treatment is unique because it involves a customized screening approach to identify patients at risk of opioid misuse, allowing for tailored treatment plans that balance pain management with minimizing the risk of addiction. Unlike standard treatments, it uses a combination of strategies, including risk assessment tools and monitoring programs, to address both chronic pain and the potential for opioid abuse. ^{1 2 3 9 11}

Research Team

Matthew R Pearson, PhD

Principal Investigator

University of New Mexico

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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

Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. [2022]

2. United States 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). [2022]

3. United States 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. [2022]

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

Screening for addiction in patients with chronic pain and "problematic" substance use: evaluation of a pilot assessment tool. [2022]

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

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

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

A research agenda for enhancing appropriate opioid prescribing in primary care. [2021]

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

Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Health benefits of an adverse events reporting system for chronic pain patients using long-term opioids. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]

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

Risk of injury associated with opioid use in older adults. [2022]

11. England pubmed.ncbi.nlm.nih.gov

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