Combating the Opioid Epidemic with Aerobic Exercise

Mowery Multidisciplinary Grant Award, University of Florida

4/01/2019 – 4/01/2020

Meredith S. Berry, PhD (University of Florida); Danielle E. Jake Schoffman, PhD (University of Florida) (Multiple PIs)

Jesse Dallery, Demetra Christou

Opioid abuse is a major source of morbidity and mortality in the U.S. and represents an urgent public health crisis. From 2002 to 2017 in the U.S. alone, deaths from opioids have more than quadrupled and more than 100,000 people begin opioid maintenance treatment (OMT) annually. Although OMT is the standard care for opioid use disorder (OUD), patients continue to experience recurrent relapse to harmful opioid abuse, high levels of sleep impairment, heightened sensitivity to pain, and weight gain that has been directly associated with OMT medications. Currently, no established adjunctive OMT treatment target craving, withdrawal, and sleep mechanisms. A promising adjunct treatment option for OUD is the addition of a supervised aerobic exercise program to OMT. However, although exercise treatment for OUD is persuasive in theory with strong preclinical support, no sustained human clinical trials have assessed its effectiveness or mechanistic underpinnings. Despite this, initial evidence for short-term exercise in OMT patients demonstrates reasonable adherence and brief lab studies show craving reductions in other substance use populations. Based on this evidence, this line of research aims to develop and refine (R34) and then rigorously determine (R01) the effectiveness of a supervised aerobic exercise program for OMT patients. This R34 will examine the selection of an optimal device to objectively measure sleep and physical activity (PA), feasibility and acceptability, optimization of strategies to boost intervention adherence, and examine effects of the intervention versus control on (i) biologically verified urinalysis results of illicit drug-use, (ii) craving, withdrawal, and behavioral economic demand for opioids, and (iii) objective and self-reported sleep metrics. The specific aims of the study are: Aim 1: Evaluation and Selection of Technology to Objectively Measure Sleep and PA. In a two-week test, 15 patients will wear two activity monitors to evaluate which device yields the best compliance and highest quality data Semi structured interviews will be conducted with patients to gather input on device selection, proposed topics for health education control group, and proposed study procedures to boost intervention adherence. Aim 2: Feasibility and Acceptability. In the randomized feasibility trial (n=70 patients), we will examine the feasibility of (a) recruitment, (b) intervention adherence, (c) intervention acceptability, (d) trial retention for the aerobic exercise intervention relative to the health education control. Aim 3: Evaluate Concurrent Features of OMT and Sleep. We will examine the effects of aerobic exercise versus control on (a) urinalysis results of illicit drug-use, (b) self-reported craving, withdrawal and behavioral economic demand for opioids, and (c) objective and self-reported sleep quality.

Opioid abuse is a major source of morbidity and mortality in the U.S., and although opioid maintenance therapy is the standard care for opioid use disorder, patients continue to experience recurrent relapse to harmful opioid abuse, high levels of sleep impairment, heightened sensitivity to pain, and weight gain that has been directly associated with opioid maintenance therapy medications. A promising adjunct treatment option for opioid use disorder is the addition of a supervised aerobic exercise program to opioid maintenance therapy, although no sustained human clinical trials have assessed its effectiveness or mechanistic underpinnings. Based on this evidence, this line of research aims to develop and refine and then rigorously determine the effectiveness of a supervised aerobic exercise program for opioid maintenance therapy patients.