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Completed

NCT Number: NCT01505101

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

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.

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Key information

Conditions

Chronic Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Abuse, Unspecified Use Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

FSU College of Social Work

Tallahassee, Florida, 32306-2570, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Oriented Recovery Enhancement

Behavioral

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.

Conventional Support Group (SG)

Behavioral

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.

Primary outcomes

  1. Pain severity, pain functional interference

    Time frame: 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.

  2. Opioid craving

    Time frame: 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.

  3. Opioid misuse behaviors

    Time frame: Baseline, immediately following treatment, and at 3 month follow-up

    Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure

  4. Well-being

    Time frame: Baseline, immediately following treatment, and at 3 month follow-up

    Change in well-being as measured by the WHO-5

Secondary outcomes

  1. Attentional bias

    Time frame: Baseline and immediately following treatment

    Change in attentional bias as measured by a dot probe task

  2. Psychophysiological cue-reactivity

    Time frame: Baseline and immediately following treatment

    Change in psychophysiological cue-reactivity

  3. Emotional response inhibition

    Time frame: Baseline and immediately following treatment

    Change in emotional response inhibition

  4. Pain coping strategies

    Time frame: Baseline, intervention midpoint, and immediately following treatment

    Change in reinterpretation of pain sensations, catastrophizing, and suppression.

  5. Anhedonia

    Time frame: Baseline and immediately following treatment

    Change in anhedonia

  6. Fear of pain

    Time frame: Baseline and immediately following treatment

    Change in fear of pain

  7. Mindfulness

    Time frame: Baseline, intervention midpoint, and immediately following treatment

    Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale

  8. Positive reappraisal

    Time frame: Baseline and immediately following treatment

    Change in positive reappraisal

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Fahs Beck Fund for Research and Experimentation
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2012
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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