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Negating Opioid and Pain Actively Through Intervention

Negating Opioid and Pain Actively Through Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03306147
Acronym
NOPAIN
Enrollment
33
Registered
2017-10-10
Start date
2017-10-12
Completion date
2018-05-17
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Opioid Use, Pain

Keywords

Pain, Opioid, Drug monitoring, Pain education

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPain education with follow up encounters

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

Sponsors

Cardinal Health
CollaboratorINDUSTRY
Loma Linda University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in opioid prescription strengthChange in prescription strength between date of subject enrollment and 90 days after subject enrollment dateOpioid usage will be measured by changes in prescription strength of morphine milligram equivalents

Secondary

MeasureTime frameDescription
Reduction in pain as evidenced by decrease in opioid daily doseChange in daily opioid use between date of subject enrollment and 90 days after subject enrollment dateSubject will keep a daily opioid calendar to track their opioid daily dose
Improvement in quality of life score as measured by the PEG pain screening tool by units on a scaleChange 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 dateSurvey will be administered by investigators and completed by the patients before and after the interventions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026