Chronic PainPhase 1NCT01505101

Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

A Phase 1 study testing Mindfulness-Oriented Recovery Enhancement and Conventional Support Group (SG) in people with Chronic Pain and Opioid Abuse, Unspecified Use, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Opioid Abuse, Unspecified Use
What is being tested?: Mindfulness-Oriented Recovery Enhancement and Conventional Support Group (SG)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Jul 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

FSU College of Social Work
Tallahassee, Florida, 32306-2570

Other trials in United States

About this study

Official title: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms

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.

Read the 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.

Conditions: Chronic Pain, Opioid Abuse, Unspecified Use
Being tested: Mindfulness-Oriented Recovery Enhancement, Conventional Support Group (SG)
Medical subject headings: Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Oriented Recovery EnhancementBehavioural
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.
Conventional Support Group (SG)Behavioural
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.

Study groups in NCT01505101
Study group	Role	What they receive
Mindfulness-Oriented Recovery Enhancement	Experimental	Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)	Active comparator	Not described Receives: Behavioral: Conventional Support Group (SG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain severity, pain functional interference
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Measured: 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.
Measured: 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
Measured: Baseline, immediately following treatment, and at 3 month follow-up
Well-being
Change in well-being as measured by the WHO-5
Measured: Baseline, immediately following treatment, and at 3 month follow-up

Secondary outcomes (8)

Attentional bias
Change in attentional bias as measured by a dot probe task
Measured: Baseline and immediately following treatment
Psychophysiological cue-reactivity
Change in psychophysiological cue-reactivity
Measured: Baseline and immediately following treatment
Emotional response inhibition
Change in emotional response inhibition
Measured: Baseline and immediately following treatment
Pain coping strategies
Change in reinterpretation of pain sensations, catastrophizing, and suppression.
Measured: Baseline, intervention midpoint, and immediately following treatment
Anhedonia
Change in anhedonia
Measured: Baseline and immediately following treatment
Fear of pain
Change in fear of pain
Measured: Baseline and immediately following treatment
Mindfulness
Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
Measured: Baseline, intervention midpoint, and immediately following treatment
Positive reappraisal
Change in positive reappraisal
Measured: Baseline and immediately following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jul 2013

First posted6 Jan 2012 (estimated)
Study startOct 2011
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01505101
Sponsor's protocol ID: DA032517-01
Other IDs: R03DA032517
Status last verified: Aug 2014
First submitted: 4 Jan 2012
Last updated: 6 Aug 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
ClinicalTrials.gov ID: NCT01505101
Acronym / sponsor ID: DA032517-01
Conditions: Chronic Pain, Opioid Abuse, Unspecified Use
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Fahs Beck Fund for Research and Experimentation
Study start: Oct 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 6 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Oriented Recovery Enhancement	Experimental	Behavioral: Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)	Active comparator	Behavioral: Conventional Support Group (SG)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Oriented Recovery EnhancementMORE 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.	Behavioural	Mindfulness-Oriented Recovery Enhancement
Conventional Support Group (SG)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.	Behavioural	Conventional Support Group (SG)

Primary outcome

Pain severity, pain functional interference
Time frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Opioid craving
Time frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Opioid misuse behaviors
Time frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Well-being
Time frame: Baseline, immediately following treatment, and at 3 month follow-up
Change in well-being as measured by the WHO-5

8 secondary outcomes

Attentional bias
Time frame: Baseline and immediately following treatment
Psychophysiological cue-reactivity
Time frame: Baseline and immediately following treatment
Emotional response inhibition
Time frame: Baseline and immediately following treatment
Pain coping strategies
Time frame: Baseline, intervention midpoint, and immediately following treatment
Anhedonia
Time frame: Baseline and immediately following treatment
Fear of pain
Time frame: Baseline and immediately following treatment
Mindfulness
Time frame: Baseline, intervention midpoint, and immediately following treatment
Positive reappraisal
Time frame: Baseline and immediately following treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric L Garland, PhD principal investigator

Florida State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain severity, pain functional interference (time frame: Baseline, immediately following treatment, and at 3 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01505101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.