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OpenTrials
Completed

NCT Number: NCT03306147

Negating Opioid and Pain Actively Through Intervention

Chronic pain is one of the most prevalent and debilitating medical conditions and opioid analgesics are a commonly prescribed class of medications in the United States. Opioid efficacy has been proven in terms of managing acute and chronic pain; however, opioid overdose deaths, addictions, and diversions have all continued to increase over the years. The purpose of this study is to increase patient engagement in pain management and education, and to decrease opioid use by 10% over the study period. This study will also help present opportunities for future studies to obtain insight regarding the chronic use of opioids.

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Key information

Conditions

Pain Chronic Pain Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

About this study

The institutional review board has approved this prospective single-center study at a large 900-bed academic university medical center. The electronic medical record system will identify 300 patients, who are at least 18 years of age, with a history of opioid use for 3 or more months, or who are currently prescribed and are using long-acting or extended release opioids. Procedures by student pharmacists, pharmacy residents, and pharmacists will include reviewing medical records and prescription drug monitoring programs for the use of opioids, evaluating baseline pain, quality of life, and satisfaction via questionnaires and assessment questions, and performing thorough medication consultations on current opioid regimens. Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician. Opioid usage, pain, quality of life, and patient satisfaction will be assessed. The primary outcome measured will be a decrease in opioid usage in morphine milligram equivalents. Secondary outcomes include change in quality of life and patient satisfaction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years of age
  • history of opioid use for 3 or more months or
  • currently prescribed and are using long-acting or extended release opioids

Exclusion criteria

  • substance use
  • oncology patients
  • hematology patients

Treatment and study plan

Pain education with follow up encounters

Behavioral

Patient pain review, counseling and education by pharmacists and physicians in follow up encounters

Primary outcomes

  1. Decrease in opioid prescription strength

    Time frame: Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date

    Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents

Secondary outcomes

  1. Reduction in pain as evidenced by decrease in opioid daily dose

    Time frame: Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date

    Subject will keep a daily opioid calendar to track their opioid daily dose

  2. Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale

    Time frame: Change in quality of life score as measured by the PEG pain screening tool by units on a scale between date of subject enrollment and 90 days after subject enrollment date

    Survey will be administered by investigators and completed by the patients before and after the interventions

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Cardinal Health

Registry information

Acronym: NOPAIN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2017
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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