Text Size

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

This study is not yet open for participant recruitment.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01681264
First received: August 31, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.


Condition Intervention
Pain
 Drug: Guanfacine
Drug: Morphine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Quantitative Sensory Testing (QST) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Quantitative Sensory Testing (QST) results will be used to compare the 5 treatment groups.


Secondary Outcome Measures:
  • Heat Pain Threshold [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The investigators will measure the heat pain threshold using Quantitative Sensory Testing (QST). The testing will be done at three of the four visits.

  • Heat Pain Tolerance [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The investigators will measure the heat pain tolerance using Quantitative Sensory Testing (QST). The testing will be done at three of the four visits.

  • Temporal Pain Summation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The investigators will measure the temporal pain summation using Quantitative Sensory Testing (QST). The testing will be done at three of the four visits.

  • Detecting Diffuse Noxious Inhibitory Control (DNIC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The investigators will detect the Diffuse Noxious Inhibitory Control (DNIC) using Quantitative Sensory Testing (QST). The DNIC is when pain A is lessened by or inhibited by another pain B. The testing will be done at three of the four visits.

  • Needle Stick Test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The investigators will measure the subject's pain score before and after the subcutaneous needle stick. The testing will be done at three of the four visits.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guanfacine:morphine

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

Subjects who are randomized into the guanfacine:morphine groups will be compared to the placebo-mixed or placebo only groups.

 Drug: Guanfacine

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 10 weeks of drug treatment (combination or placebo).

Drug: Morphine

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 10 weeks of drug treatment (combination or placebo).
Placebo Comparator: Placebo

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

Subjects who are in the placebo-mixed or placebo only groups will be compared to the guanfacine:morphine groups.

 Drug: Guanfacine

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 10 weeks of drug treatment (combination or placebo).

Drug: Morphine

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 10 weeks of drug treatment (combination or placebo).

Drug: Placebo

Subjects will be randomized into 1 of the following 5 treatment groups:

  1. guanfacine (2mg): morphine
  2. guanfacine (1mg): morphine
  3. guanfacine (2mg): placebo
  4. morphine: placebo
  5. placebo:placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 10 weeks of drug treatment (combination or placebo).

Detailed Description:

This aim proposes that guanfacine would be a useful drug to deter opioid-induced hyperalgesia (OIH) when combined with an opioid (morphine) in chronic pain management.

  Eligibility

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

Inclusion Criteria:

  1. back and neck pain refers to pain resulting from conditions such as degenerative facet joint disease, degenerative disc disease, radiculitis, or post-laminectomy pain syndrome; and
  2. abdominal and pelvic pain includes pain due to chronic pancreatitis, endometriosis, etc.
  3. subjects are 18 to 65 years of age,
  4. subjects have a pain condition described above for at least six months and a VAS score of 5 or above, and
  5. subjects have not received guanfacine (or other alpha-2AR agonists) or opioid treatment for at least the past 6 months.

Exclusion Criteria:

  1. have sensory deficits at the site of QST or have Raynaud's syndrome,
  2. have pending litigation related to chronic pain condition,
  3. are on a methadone or suboxone maintenance program for addiction treatment d) currently in a treatment program for alcohol abuse,

e) have major psychiatric disorders that required hospitalization in the past 6 months such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorders, f) are using illicit drugs, recreational drugs, or drugs not prescribed to them as detected by a urine toxicology/drug screen, g) are pregnant or lactating; h) allergic to opioid or guanfacine, i) are on such drugs as valproic acid, antibiotics, antifungal drugs, St. John wort, ACE inhibitors, nefazodone (antidepressant), calcium channel blockers, HIV or AIDS medications, seizure medications, or alpha2-AR agonists and j) have hypotension or bradycardia.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681264

Contacts
Contact: Trang T Vo, B.A. 617-724-6102 tvo3@partners.org
Contact: Abigail S Cohen, B.A. 617-724-6102 acohen18@partners.org

Locations
United States, Massachusetts
Center for Translational Pain Research Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Trang T Vo, B.A.     617-724-6102     tvo3@partners.org    
Contact: Abigail S Cohen, B.A.     617-724-6102     acohen18@partners.org    
Principal Investigator: Jianren Mao, M.D., Ph.D.            
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
  More Information

Additional Information:
Center for Translational Pain Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01681264     History of Changes
Other Study ID Numbers: 2012P-001851
Study First Received: August 31, 2012
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain
Pain Management

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Guanfacine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013