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

Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Abuse, Unspecified Use
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Conventional Support Group (SG)

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306-2570
      • FSU College of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Oriented Recovery Enhancement	Behavioral: Mindfulness-Oriented Recovery Enhancement; MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.
Active Comparator: Conventional Support Group (SG)	Behavioral: Conventional Support Group (SG); The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity, pain functional interference	Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.	Baseline, immediately following treatment, and at 3 month follow-up
Opioid craving	Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.	Baseline, immediately following treatment, and at 3 month follow-up
Opioid misuse behaviors	Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure	Baseline, immediately following treatment, and at 3 month follow-up
Well-being	Change in well-being as measured by the WHO-5	Baseline, immediately following treatment, and at 3 month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute on Drug Abuse (NIDA); Fahs Beck Fund for Research and Experimentation
• Investigators: Principal Investigator: Eric L Garland, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: DA032517-01; R03DA032517 (U.S. NIH Grant/Contract)