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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

January 4, 2012
August 4, 2014
October 2011
July 2013   (final data collection date for primary outcome measure)
  • 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
  • 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 and functional interference 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
  • 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
Complete list of historical versions of study NCT01505101 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Pain
  • Opioid Abuse, Unspecified Use
  • 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.
  • Experimental: Mindfulness-Oriented Recovery Enhancement
    Intervention: Behavioral: Mindfulness-Oriented Recovery Enhancement
  • Active Comparator: Conventional Support Group (SG)
    Intervention: Behavioral: Conventional Support Group (SG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01505101
DA032517-01, R03DA032517
Yes
Eric Garland, Florida State University
Florida State University
  • National Institute on Drug Abuse (NIDA)
  • Fahs Beck Fund for Research and Experimentation
Principal Investigator: Eric L Garland, PhD Florida State University
Florida State University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP