Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Florida State University
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- Pain severity, pain functional interference
Study Overview
Brief Summary
Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.
Detailed Description
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic pain diagnosis (ICD-9 diagnoses 338.xx)
- •treatment with prescription opioids for > 3 months
Exclusion Criteria
- •prior mindfulness training
- •persons who are experiencing acute opioid withdrawal
- •suicidal ideation
- •psychosis
Outcomes
Primary Outcomes
Pain severity, pain functional interference
Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Opioid craving
Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Opioid misuse behaviors
Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Well-being
Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in well-being as measured by the WHO-5
Secondary Outcomes
- Attentional bias(Baseline and immediately following treatment)
- Psychophysiological cue-reactivity(Baseline and immediately following treatment)
- Emotional response inhibition(Baseline and immediately following treatment)
- Pain coping strategies(Baseline, intervention midpoint, and immediately following treatment)
- Anhedonia(Baseline and immediately following treatment)
- Fear of pain(Baseline and immediately following treatment)
- Mindfulness(Baseline, intervention midpoint, and immediately following treatment)
- Positive reappraisal(Baseline and immediately following treatment)
Investigators
Eric Garland
Assistant Professor
Florida State University