Trial record 8 of 53 for:    guanfacine

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02192398
First received: July 15, 2014
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

Combination of guanfacine with opioid medication as a standard treatment for chronic pain.


Condition Intervention
Chronic Pain
Drug: Guanfacine
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Quantitative Sensory Testing (QST) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quantitative Sensory Testing (QST) results will be used to compare the 3 treatment groups.


Secondary Outcome Measures:
  • Heat Pain Threshold [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will be measured for their heat pain threshold using Quantitative Sensory Testing (QST). The testing will be done at 3 of the 4 visits.

  • Heat Pain Tolerance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will be measured for their heat pain tolerance using Quantitative Sensory Testing (QST). The testing will be done at 3 of the 4 visits.

  • Temporal Pain Summation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will be measured for their temporal pain summation using Quantitative Sensory Testing (QST). The testing will be done at 3 of the 4 visits.

  • Detecting Diffuse Noxious Inhibitory Control (DNIC) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will be measured for their Diffuse Noxious Inhibitory Control (DNIC). The testing will be done at 3 of the 4 visits.

  • Heat Sensation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will be measured for their heat sensation using Quantitative Sensory Testing (QST). The testing will be done at 3 of the 4 visits.


Estimated Enrollment: 120
Study Start Date: September 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guanfacine (2mg)

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo

Subjects will be instructed to take one capsule in the evening for 4 weeks.

Drug: Guanfacine

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).

Other Name: Tenex, Intuniv
Active Comparator: Guanfacine (1mg)

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo

Subjects will be instructed to take one capsule in the evening for 4 weeks.

Drug: Guanfacine

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo

To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).

Other Name: Tenex, Intuniv
Placebo Comparator: Placebo

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo

Subjects will be instructed to take one capsule in the evening for 4 weeks.

Drug: Placebo

Subjects will be randomized into 1 of the following 3 treatment groups:

  1. guanfacine (2mg)
  2. guanfacine (1mg)
  3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).
Other Name: Placebo, sugar pill

Detailed Description:

This aim proposes that guanfacine would be a useful drug to reverse opioid-induced hyperalgesia (OIH) when combined with opioids 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

  • 18-65 years old
  • Chronic neck or back pain condition for at least 6 months
  • VAS score of 4-8, despite opioid therapy
  • On a stable morphine equivalent dose of at least 60mg/day and ≤ 240mg/day for at least 3 months

Exclusion Criteria

  • Has taken Methadone, Suboxone, Fentanyl, and/or Tramadol in the last six (6) months
  • Has taken guanfacine (or other alpha-2AR agonists) in the last six (6) months
  • Changes to current or adding new pain treatment while enrolled in the study (i.e. opiates, epidural steroid injection) will be reviewed by the study physician
  • Unable to independently provide informed written consent
  • Sensory deficits at site of QST, such as peripheral neuropathy
  • Intolerable allergies or has had a severe adverse reaction to study medication (i.e. guanfacine, lactose, vitamin B2 a.k.a. riboflavin)
  • Takes vitamin B2 > 1.6mg/day during the study
  • Pregnant or breastfeeding
  • Pending litigation related to neck or back pain
  • Diagnosed with Raynaud's syndrome
  • Has other chronic pain conditions such as fibromyalgia or joint osteoarthritis that are predominant over back and neck pain with regard to its intensity (VAS)
  • Has known pre-existing severe cardiovascular disease (i.e. arrhythmia - prolonged QT interval > 440ms), cerebrovascular disease/accident (i.e., stroke), hepatic or renal impairment, CNS condition, metabolic condition, or history of syncope
  • Hypotension (SBP < 90 mmHg and DBP < 60 mmHg for female or SBP < 100 mmHg and DBP < 60 mmHg for male; measured while in a sitting position) will be reviewed by a study physician
  • Bradycardia (resting heart rate < 60 bpm) will be reviewed by a study physician
  • Subjects are on antihypertensive drugs (e.g., a beta-blocker) that result in hypotension and/or bradycardia as defined above
  • Tests positive for illicit drugs, marijuana, or non-prescribed drugs
  • Major psychiatric disorders that required hospitalization in the past 6 months such as: major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorders
  • Currently in a treatment program for alcohol or drug abuse, or currently on methadone or buprenorphine (i.e. suboxone, subutex) for treatment of addiction, or currently prescribed stimulants for treatment of ADHD
  • History of substance or alcohol abuse (meets DSM IV criteria) per medical record or subject admission
  • Subjects are on medications that serve as CYP3A4/5 inhibitors or CYP3A4 inducers including, but are not limited to, valproic acid, macrolide antibiotics, antifungal drugs, St. John wort, ACE inhibitors, nefazodone (antidepressant), calcium channel blockers, H2-receptor antagonists, anti-HIV or AIDS drugs, and antiepileptic drugs
  • Subjects are on medications that are ligands for alpha2-adrenergic receptors including antipsychotic drugs (e.g. clozapine) and tricyclic or tetracyclic antidepressants (e.g. imipramine, mirtazapine, mianserin). Any medications taken by a subject at the enrollment will be reviewed regarding their compatibility with guanfacine as well as possible confounding side effects. Subjects will be allowed to take non-opioid pain medications except for gabapentinoids and amitriptyline/nortriptyline as far as such medications do not have incompatibility with guanfacine.
  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: NCT02192398

Contacts
Contact: MGH Center for Translational Pain Research 617-724-6102 mghpainresearch@partners.org

Locations
United States, Massachusetts
MGH Center for Translational Pain Research Recruiting
Boston, Massachusetts, United States, 02114
Contact: MGH Center for Translational Pain Research    617-724-6102    mghpainresearch@partners.org   
Principal Investigator: Jianren Mao, M.D., Ph.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02192398     History of Changes
Other Study ID Numbers: 2014P-001377, 1R01DA036564-01
Study First Received: July 15, 2014
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain
Pain management
Neck
Back

Additional relevant MeSH terms:
Guanfacine
Chronic Pain
Hyperalgesia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014