Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

July 21, 2020 updated by: Jianren Mao, MD, PhD, Massachusetts General Hospital
The MGH Center for Translational Pain Research is seeking patients with chronic pain for a research study. The study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of one visit, in which an interview, physical exam, lab work (urine test) and sensory testing will be done. The testing (Quantitative Sensory Testing) is noninvasive (no needles) and involves heat and cold stimulation. Compensation and some parking reimbursement provided.

Study Type

Observational

Enrollment (Actual)

419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Center for Translational Pain Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The groups of subjects on chronic opioid and non-opioid treatment for chronic pain will be recruited from the MGH Pain Center's patients. We want to emphasize that our MGH Pain Center patient population comprehends a significant number of patients on stable dose of non-opioid and opioid pain medication for chronic pain. The investigators and study staff will search daily the MGH Pain Center clinic list and will approach the patients who might qualify for the study. The group of opioid naive subjects will be recruited by advertising in local newspapers and by using e-mail announcements through Partners HealthCare system.

Description

a. Inclusion/exclusion criteria

Inclusion Criteria for the group with chronic pain on chronic treatment with opioids:

  1. Subject has chronic pain and is on stable chronic opioid treatment (morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for chronic pain for at least one month. We consider stable treatment if no change in the type and amount of daily opioid treatment for one month. Only patients with minimal daily opioid dose of at least 30 mg morphine equianalgesic dose will be included.
  2. Subject is age 18 to 65 years.

Inclusion Criteria for the group with chronic pain on chronic treatment with non-opioids (currently not recruiting):

  1. Subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month.
  2. Subject is age 18 to 65 years.

Inclusion Criteria for the group of opioid-naive healthy volunteers without chronic pain (currently not recruiting):

  1. Subject is opioid naive meaning he/she did not receive chronic opioid treatment in the past or present, and did not receive acute treatment with opioids in the last 1 month
  2. Subject does not have pain
  3. Subject is age 18 to 65 years.

Exclusion Criteria for all groups:

  1. Subject has lost tactile sensation in the sites for QST testing (upper extremities)
  2. Subject has scar tissue or acute injury in the skin areas for QST testing (upper extremities)
  3. Subject has neurological disease or a medical condition causing peripheral polyneuropathy and sensory changes (including but not limited to diabetes, alcoholism, AIDS, thyroid disease, liver or kidney disorders). It is the presence of neuropathy, not the causative disease itself, that is the exclusion criteria.
  4. Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months; peripheral neurolytic block within two-months; injection therapy for pain within four-weeks; sympathetic block within six months.
  5. Subject has litigation pending relative to their chronic pain.
  6. Subject has major psychiatric disorder (major depression disorder; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); any known history of these conditions will exclude participation.
  7. Subject has used illicit drugs within past 6 months.
  8. Subject is pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
  • subjects with no pain and no opioid treatment for at least six months
  • subjects receive quantitative sensory testing (QST)
Device: Quantitative Sensory Testing (QST)
QST consists of a series of heat and cold stimulation tests.
Pain, no opioid
  • subjects have chronic pain but have not taken any opioid medication for at least 3 months
  • subjects receive QST
Device: Quantitative Sensory Testing (QST)
QST consists of a series of heat and cold stimulation tests.
Pain, opioid
  • subjects have chronic pain and have been taking opioid medication for at least 3 months
  • subjects receive QST
Device: Quantitative Sensory Testing (QST)
QST consists of a series of heat and cold stimulation tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to warm/cold temperature
Time Frame: 2 hours
Responses to warm/cold temperatures will be recorded by the Quantitative Sensory Testing device (QST).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Jianren Mao, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003P 000110
  • MGH Fund # 1200-204727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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