Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/17/2019 |
| Start Date: | August 2015 |
| End Date: | June 2020 |
| Contact: | Stephen Bruehl, PhD |
| Email: | Stephen.bruehl@vumc.org |
| Phone: | 615-936-1821 |
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).
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).
This project will determine whether enhancing endogenous opioids (via aerobic exercise
training) permits achieving desired levels of analgesia with lower dosages of opioid
analgesics, and fewer side effects and abuse-relevant drug effects. This 4 year project will
test study hypotheses in a sample of 116 chronic low back pain patients. The study will have
two key elements: 1) a randomized, controlled aerobic exercise manipulation in CP patients
completing daily electronic pain diaries and 2) laboratory evoked thermal pain protocols pre-
and post-exercise permitting direct examination of changes in both opioid analgesic effects
(in response to a series of incremental morphine doses) and EO activity (indexed by comparing
pain responses after placebo vs. opioid blockade).
The study will employ a mixed between/within-subjects design using double-blind,
counterbalanced, placebo-controlled administration of both an opioid antagonist (naloxone)
and an opioid agonist (morphine). The study will use a 6 week supervised aerobic exercise
manipulation, with subjects randomly assigned to the exercise protocol or a no exercise
control condition. All participants will undergo three identical laboratory pain-induction
sessions (each ≈5 days apart) prior to randomization to experimental condition, and again at
the end of the 6 week exercise manipulation period (regardless of exercise group assignment)
during which they will receive the 3 study drugs and participate in controlled laboratory
evaluation of evoked thermal pain responsiveness.
training) permits achieving desired levels of analgesia with lower dosages of opioid
analgesics, and fewer side effects and abuse-relevant drug effects. This 4 year project will
test study hypotheses in a sample of 116 chronic low back pain patients. The study will have
two key elements: 1) a randomized, controlled aerobic exercise manipulation in CP patients
completing daily electronic pain diaries and 2) laboratory evoked thermal pain protocols pre-
and post-exercise permitting direct examination of changes in both opioid analgesic effects
(in response to a series of incremental morphine doses) and EO activity (indexed by comparing
pain responses after placebo vs. opioid blockade).
The study will employ a mixed between/within-subjects design using double-blind,
counterbalanced, placebo-controlled administration of both an opioid antagonist (naloxone)
and an opioid agonist (morphine). The study will use a 6 week supervised aerobic exercise
manipulation, with subjects randomly assigned to the exercise protocol or a no exercise
control condition. All participants will undergo three identical laboratory pain-induction
sessions (each ≈5 days apart) prior to randomization to experimental condition, and again at
the end of the 6 week exercise manipulation period (regardless of exercise group assignment)
during which they will receive the 3 study drugs and participate in controlled laboratory
evaluation of evoked thermal pain responsiveness.
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
We found this trial at
2
sites
2201 West End Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Stephen Bruehl, PhD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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