Clinical trial NCT03298269: Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Official title: Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.


Eligibility criteria: Inclusion Criteria:

* Age 18-60+
* Current chronic pain condition
* Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days

Exclusion Criteria:

* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
* Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
* Opioid misuse as determined by Current Opioid Misuse Measure

Primary outcomes:
measure: Change in pain symptoms
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in aberrant drug-related behaviors
timeFrame: Change from baseline through study completion (9 months post-treatment)
Secondary outcomes:
measure: Change in emotional distress
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in opioid dose
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in opioid craving
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in interoceptive awareness
timeFrame: Change from baseline through 8 weeks
measure: Change in reappraisal
timeFrame: Change from baseline through 8 weeks
measure: Change in savoring
timeFrame: Change from baseline through 8 weeks
measure: Change in meditative experiences
timeFrame: Change from baseline through 8 weeks
measure: Change in body sensations
timeFrame: Change from baseline through 8 weeks
Other outcomes:
measure: Change in cue-reactivity
timeFrame: Change from baseline through 8 weeks
measure: Change in emotion regulation
timeFrame: Change from baseline through 8 weeks
Locations:
city: Salt Lake City
country: United States
facility: College of Social Work
state: Utah
Study officials:
References:
citation: Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.
citation: Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390.