We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01505101
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : August 6, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Pain Opioid Abuse, Unspecified Use Behavioral: Mindfulness-Oriented Recovery Enhancement Behavioral: Conventional Support Group (SG) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505101


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

Responsible Party: Eric Garland, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01505101     History of Changes
Other Study ID Numbers: DA032517-01
R03DA032517 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Chronic Pain
Substance-Related Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents