Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Pain

In brief

Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (via greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will test the novel hypothesis that effective pain relief can be achieved at lower opioid analgesic doses by increasing levels of endogenous opioids (EOs).

Key facts

Study ID

NCT02469077

Run by

Vanderbilt University Medical Center

People needed

117

Starts

2015-08-01

Expected to finish

2019-09-01

Last updated by the study team

2020-09-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Intact cognitive status and ability to provide informed consent
• Ability to read and write in English sufficiently to understand and complete study questionnaires
• Age 18-55 inclusive
• Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity

You may not qualify if…

• Engagement in > 2 days/wk and > 60 min/wk of moderate or vigorous intensity activity based on responses to 6 validated survey questions at screening (CDC BRFSS)
• History of renal or hepatic dysfunction
• Current or past alcohol or substance dependence
• A history of PTSD, psychotic, or bipolar disorders
• Chronic pain due to malignancy (e.g., cancer), autoimmune disorders (e.g., rheumatoid arthritis, lupus), or fibromyalgia
• Recent daily opiate use
• Use of any opioid analgesic medications within 72 hours of study participation (confirmed through rapid urine screening conducted prior to study participation)
• Females who are pregnant
• History of cardiovascular disease (including myocardial infarction)
• History of seizure disorder
• Prior allergic reaction/intolerance to morphine or its analogs
• Presence of cardiac disease or any other medical condition that would make engaging in the aerobic exercise manipulation unsafe

Where it is running

• Rush University — Chicago, Illinois, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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