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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

419 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

* subjects with no pain and no opioid treatment for at least six months
* subjects receive quantitative sensory testing (QST)

Quantitative Sensory Testing (QST)

Intervention Type DEVICE

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

Quantitative Sensory Testing (QST)

Intervention Type DEVICE

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

Quantitative Sensory Testing (QST)

Intervention Type DEVICE

QST consists of a series of heat and cold stimulation tests.

Interventions

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Quantitative Sensory Testing (QST)

QST consists of a series of heat and cold stimulation tests.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

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.

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

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)
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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No