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

This study has been completed.
Sponsor:
Collaborators:
Fahs Beck Fund for Research and Experimentation
Information provided by (Responsible Party):
Eric Garland, Florida State University
ClinicalTrials.gov Identifier:
NCT01505101
First received: January 4, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Opioid Abuse, Unspecified Use
Behavioral: Mindfulness-Oriented Recovery Enhancement
Behavioral: Conventional Support Group (SG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Pain severity, pain functional interference [ Time Frame: Baseline, immediately following treatment, and at 3 month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in well-being as measured by the WHO-5


Secondary Outcome Measures:
  • Attentional bias [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in attentional bias as measured by a dot probe task

  • Psychophysiological cue-reactivity [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in psychophysiological cue-reactivity

  • Emotional response inhibition [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in emotional response inhibition

  • Pain coping strategies [ Time Frame: Baseline, intervention midpoint, and immediately following treatment ] [ Designated as safety issue: No ]
    Change in reinterpretation of pain sensations, catastrophizing, and suppression.

  • Anhedonia [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in anhedonia

  • Fear of pain [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in fear of pain

  • Mindfulness [ Time Frame: Baseline, intervention midpoint, and immediately following treatment ] [ Designated as safety issue: No ]
    Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale

  • Positive reappraisal [ Time Frame: Baseline and immediately following treatment ] [ Designated as safety issue: No ]
    Change in positive reappraisal


Enrollment: 115
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505101

Locations
United States, Florida
FSU College of Social Work
Tallahassee, Florida, United States, 32306-2570
Sponsors and Collaborators
Florida State University
Fahs Beck Fund for Research and Experimentation
Investigators
Principal Investigator: Eric L Garland, PhD Florida State University
  More Information

No publications provided

Responsible Party: Eric Garland, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01505101     History of Changes
Other Study ID Numbers: DA032517-01, R03DA032517
Study First Received: January 4, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014