Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

Chronic Pain Clinical Trial

Official title:

Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602535
• Other study ID #: 00078615
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 18-60+

• Current back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)

• Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure

• Willingness to participate in study interventions and assessments

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 substance dependence (other than opioid dependence)

• Presence of clinically unstable systemic illness judged to interfere with treatment

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use Disorders

Intervention

Behavioral:
• Mindfulness-Oriented Recovery Enhancement
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
• Support Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Locations

Country	Name	City	State
United States	University of Utah Primary Care Clinics	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in nonreactivity	subscale on Five Facet Mindfulness Questionnaire	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in interoceptive awareness	Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in reinterpretation of pain sensations	Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in emotion regulation	Emotion regulation as evidenced by responses on the Emotion Regulation Task	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in positive emotion	Positive emotion as evidenced by the PANAS	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in cue-reactivity	Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in attention to positive information	Attention to positive information as evidenced by the APNIS	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Other	Change in anhedonia	Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.	Change from baseline through study completion (9 months post-treatment)
Primary	Change in opioid misuse	Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen	Change from baseline through study completion (9 months post-treatment)
Primary	Change in pain severity and interference	Brief Pain Inventory	Change from baseline through study completion (9 months post-treatment)
Secondary	Change in opioid craving	Opioid craving measure from Wasan et al. 2012	Change from baseline through study completion (9 months post-treatment)
Secondary	Change in psychological distress	Depression Anxiety Stress Scale	Change from baseline through study completion (9 months post-treatment)
Secondary	Change in opioid dose	Opioid dose converted into morphine equivalents via standardized equianalgesic tables	Change from baseline through study completion (9 months post-treatment)