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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00656942
First received: April 9, 2008
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

The Massachusetts General Hospital 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.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Response to warm/cold temperature [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Responses to warm/cold temperatures will be recorded by the Quantitative Sensory Testing device (QST).


Estimated Enrollment: 164
Study Start Date: July 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656942

Locations
United States, Massachusetts
MGH Center for Translational Pain Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jianren Mao, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00656942     History of Changes
Other Study ID Numbers: 2003P 000110, MGH Fund # 1200-204727
Study First Received: April 9, 2008
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014