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Clinical Trials/NCT04567043
NCT04567043
Active, not recruiting
Not Applicable

Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention

University of Utah1 site in 1 country63 target enrollmentSeptember 24, 2020
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ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Utah
Enrollment
63
Locations
1
Primary Endpoint
Change in momentary craving
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.

Registry
clinicaltrials.gov
Start Date
September 24, 2020
End Date
September 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Garland

Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • •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
  • •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
  • •Presence of clinically unstable systemic illness judged to interfere with treatment
  • •No access to internet (which will prevent telehealth-based treatment)

Outcomes

Primary Outcomes

Change in momentary craving

Time Frame: Baseline through 1-month follow-up

Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)

Change in momentary pain: numeric rating scale

Time Frame: Baseline through 1-month follow-up

Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)

Secondary Outcomes

  • Change in momentary stress(Baseline through 1-month follow-up)
  • Change in momentary positive affect(Baseline through 1-month follow-up)
  • Change in heart rate variability(Baseline through 1-month follow-up)

Study Sites (1)

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