NCT01505101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for phase_1 chronic-pain

Timeline
Completed

Started Oct 2011

Typical duration for phase_1 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

January 4, 2012

Last Update Submit

August 4, 2014

Conditions

Chronic PainOpioid Abuse, Unspecified Use

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • Well-being

    Change in well-being as measured by the WHO-5

    Baseline, immediately following treatment, and at 3 month follow-up

Secondary Outcomes (8)

  • Attentional bias

    Baseline and immediately following treatment

  • Psychophysiological cue-reactivity

    Baseline and immediately following treatment

  • Emotional response inhibition

    Baseline and immediately following treatment

  • Pain coping strategies

    Baseline, intervention midpoint, and immediately following treatment

  • Anhedonia

    Baseline and immediately following treatment

  • +3 more secondary outcomes

Study Arms (2)

Mindfulness-Oriented Recovery Enhancement

EXPERIMENTAL
Behavioral: Mindfulness-Oriented Recovery Enhancement

Conventional Support Group (SG)

ACTIVE COMPARATOR
Behavioral: Conventional Support Group (SG)

Interventions

Mindfulness-Oriented Recovery EnhancementBEHAVIORAL

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.

Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)BEHAVIORAL

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.

Conventional Support Group (SG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic pain diagnosis (ICD-9 diagnoses 338.xx)
  • treatment with prescription opioids for \> 3 months

You may not qualify if:

  • prior mindfulness training
  • persons who are experiencing acute opioid withdrawal
  • suicidal ideation
  • psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSU College of Social Work

Tallahassee, Florida, 32306-2570, United States

Location

MeSH Terms

Conditions

Chronic PainOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Eric L Garland, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

US(1)