Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

Phase 1

Completed

• Conditions: Chronic Pain; Opioid Abuse, Unspecified Use
• Interventions: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Conventional Support Group (SG)

• Registration Number: NCT01505101
• Lead Sponsor: Florida State University

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Oriented Recovery Enhancement	Mindfulness-Oriented Recovery Enhancement	-
Conventional Support Group (SG)	Conventional Support Group (SG)	-

Primary Outcome Measures

Name	Time	Method
Pain severity, pain functional interference	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	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	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	Baseline, immediately following treatment, and at 3 month follow-up	Change in well-being as measured by the WHO-5

Secondary Outcome Measures

Name	Time	Method
Attentional bias	Baseline and immediately following treatment	Change in attentional bias as measured by a dot probe task
Psychophysiological cue-reactivity	Baseline and immediately following treatment	Change in psychophysiological cue-reactivity
Emotional response inhibition	Baseline and immediately following treatment	Change in emotional response inhibition
Pain coping strategies	Baseline, intervention midpoint, and immediately following treatment	Change in reinterpretation of pain sensations, catastrophizing, and suppression.
Anhedonia	Baseline and immediately following treatment	Change in anhedonia
Fear of pain	Baseline and immediately following treatment	Change in fear of pain
Mindfulness	Baseline, intervention midpoint, and immediately following treatment	Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
Positive reappraisal	Baseline and immediately following treatment	Change in positive reappraisal

Trial Locations

Locations (1)

FSU College of Social Work; 🇺🇸 Tallahassee, Florida, United States