Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function
CompletedNot applicableNCT02469077
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function
- Conditions
- Interventions
- Behavioral: 6 week aerobic exercise intervention
- Drug: Placebo
- Drug: Morphine
- Drug: naloxone
- Sponsor
- Vanderbilt University Medical Center
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2015-08
- Primary completion
- 2019-09
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02469077