Clinical trial NCT01505101: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
Official title: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Opioid Abuse, Unspecified Use
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Fahs Beck Fund for Research and Experimentation
First posted: 2012-01-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Pain severity, pain functional interference
timeFrame: Baseline, immediately following treatment, and at 3 month follow-up
measure: Opioid craving
timeFrame: Baseline, immediately following treatment, and at 3 month follow-up
measure: Opioid misuse behaviors
timeFrame: Baseline, immediately following treatment, and at 3 month follow-up
measure: Well-being
timeFrame: Baseline, immediately following treatment, and at 3 month follow-up
Secondary outcomes:
measure: Attentional bias
timeFrame: Baseline and immediately following treatment
measure: Psychophysiological cue-reactivity
timeFrame: Baseline and immediately following treatment
measure: Emotional response inhibition
timeFrame: Baseline and immediately following treatment
measure: Pain coping strategies
timeFrame: Baseline, intervention midpoint, and immediately following treatment
measure: Anhedonia
timeFrame: Baseline and immediately following treatment
measure: Fear of pain
timeFrame: Baseline and immediately following treatment
measure: Mindfulness
timeFrame: Baseline, intervention midpoint, and immediately following treatment
measure: Positive reappraisal
timeFrame: Baseline and immediately following treatment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: FSU College of Social Work
state: Florida
Study officials:
affiliation: Florida State University
name: Eric L Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References: