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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505101
• Other study ID #: DA032517-01
• Secondary ID: R03DA032517
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2012
• Last updated: August 4, 2014
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Abuse, Unspecified Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	FSU College of Social Work	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	Fahs Beck Fund for Research and Experimentation, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity, pain functional interference	Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.	Baseline, immediately following treatment, and at 3 month follow-up	No
Primary	Opioid craving	Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.	Baseline, immediately following treatment, and at 3 month follow-up	No
Primary	Opioid misuse behaviors	Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure	Baseline, immediately following treatment, and at 3 month follow-up	No
Primary	Well-being	Change in well-being as measured by the WHO-5	Baseline, immediately following treatment, and at 3 month follow-up	No
Secondary	Attentional bias	Change in attentional bias as measured by a dot probe task	Baseline and immediately following treatment	No
Secondary	Psychophysiological cue-reactivity	Change in psychophysiological cue-reactivity	Baseline and immediately following treatment	No
Secondary	Emotional response inhibition	Change in emotional response inhibition	Baseline and immediately following treatment	No
Secondary	Pain coping strategies	Change in reinterpretation of pain sensations, catastrophizing, and suppression.	Baseline, intervention midpoint, and immediately following treatment	No
Secondary	Anhedonia	Change in anhedonia	Baseline and immediately following treatment	No
Secondary	Fear of pain	Change in fear of pain	Baseline and immediately following treatment	No
Secondary	Mindfulness	Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale	Baseline, intervention midpoint, and immediately following treatment	No
Secondary	Positive reappraisal	Change in positive reappraisal	Baseline and immediately following treatment	No