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

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Mindfulness-Oriented Recovery Enhancement
  • Active Comparator: Conventional Support Group (SG)

Outcome Measures for this Clinical Trial

Primary Measures

  • Pain severity, pain functional interference
    • Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
      Safety Issue?: No
  • Opioid craving
    • Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
      Safety Issue?: No
  • Opioid misuse behaviors
    • Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
      Safety Issue?: No
  • Well-being
    • Time Frame: Baseline, immediately following treatment, and at 3 month follow-up
      Safety Issue?: No

Secondary Measures

  • Attentional bias
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No
  • Psychophysiological cue-reactivity
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No
  • Emotional response inhibition
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No
  • Pain coping strategies
    • Time Frame: Baseline, intervention midpoint, and immediately following treatment
      Safety Issue?: No
  • Anhedonia
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No
  • Fear of pain
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No
  • Mindfulness
    • Time Frame: Baseline, intervention midpoint, and immediately following treatment
      Safety Issue?: No
  • Positive reappraisal
    • Time Frame: Baseline and immediately following treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Florida State University
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eric Garland, Assistant Professor – Florida State University
  • Overall Official(s)
    • Eric L Garland, PhD, Principal Investigator, Florida State University
  • Overall Contact(s)
    • Eric L Garland, PhD, 850-645-9571, egarland@fsu.edu

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01505101