Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
This study is currently recruiting participants.
Verified March 2012 by Florida State University
Sponsor:
Florida State University
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: March 18, 2012
Last verified: March 2012
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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
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505101
Contacts
| Contact: Eric L Garland, PhD | 850-645-9571 | egarland@fsu.edu |
Locations
| United States, Florida | |
| FSU College of Social Work | Recruiting |
| Tallahassee, Florida, United States, 32306-2570 | |
| Contact: Eric L Garland, PhD 850-645-9571 egarland@fsu.edu | |
| Principal Investigator: Eric L Garland, PhD | |
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: | March 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013