N/A N=93 Randomized Double-blind Treatment

Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02469077 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Mean of the Change in Morphine Dosage (in mg) Required to Achieve 25% Reduction in Thermal Evoked Pain Responses Relative to Baseline (Pre-intervention) Placebo Condition Responses — 4.17; 6.34; -1.62; 0.92 mg — p=0.12

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 6 week aerobic exercise intervention (Behavioral); Placebo (Drug); Morphine (Drug); naloxone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean of the Change in Morphine Dosage (in mg) Required to Achieve 25% Reduction in Thermal Evoked Pain Responses Relative to Baseline (Pre-intervention) Placebo Condition Responses	4.17; 6.34; -1.62; 0.92	0.12
PRIMARY Mean Change in 5-day Electronic Diary Ratings of Low Back Pain Intensity	2.75; 2.82; 0.72; 0.18	.04 sig
SECONDARY Mean Change in Placebo Condition Ratings of Acute Thermal Pain Intensity on the McGill Pain Questionnaire-Short Form	10.23; 7.83; 0.45; -2.14	.03 sig
SECONDARY Mean Within-participant Changes From Pre- to Post-intervention in Opioid Blockade Effects (Within-participant Difference Between Naloxone and Placebo Conditions) for Ratings of Acute Thermal Pain Intensity on the McGill Pain Questionnaire-Short Form	-0.33; 0.92; 1.97; -0.61	0.17
SECONDARY Mean Change in McGill Pain Questionnaire-2 Total Chronic Back Pain Ratings	2.66; 3.01; 1.60; 1.36	0.13
SECONDARY Mean Within-participant Changes From Pre- to Post-intervention in Opioid Blockade Effects (Within-participant Difference Between Naloxone and Placebo Conditions) for McGill Pain Questionnaire-2 Total Ratings of Back Pain.	0.11; 0.18; -0.12; -0.24	.98
SECONDARY Mean Change in Positive and Negative Affect Scale-Negative Affect Subscale Ratings.	16.38; 15.43; 0.45; -2.14	0.52
SECONDARY Mean Change in Morphine Condition Visual Analog Scale (VAS) Opioid Effects Scale-Euphoria Subscale Ratings	100.60; 108.24; 3.19; 0.75	0.65
SECONDARY Mean Change in Morphine Condition Visual Analog Scale (VAS) Opioid Effects Scale-Sedation Subscale Ratings	66.58; 30.63; 12.89; -9.95	0.1
SECONDARY Mean Change in Morphine Condition Visual Analog Scale (VAS) Opioid Effects - Unpleasantness Subscale Ratings	33.58; 16.52; -3.21; 1.86	.046 sig
SECONDARY Mean Change in Morphine Condition Drug Effects, Liking, and Take Again (DELTA) -Drug Effect Subscale Ratings	2.72; 2.52; 0.10; -0.12	0.61
SECONDARY Mean Change in Morphine Condition Drug Effects, Liking, and Take Again (DELTA) -Drug Liking Subscale Ratings	52.03; 52.89; 4.13; 1.04	0.4
SECONDARY Mean Change in Morphine Condition Drug Effects, Liking, and Take Again (DELTA) -Take Again Subscale Ratings	54.49; 55.04; 4.40; 1.70	0.57

Summary

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).

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02469077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.