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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Guanfacine (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Jianren Mao, M.D., Ph.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
MGH Center for Translational Pain Research, Phone: 617-724-6102, Email: mghpainresearch@partners.org

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Quantitative Sensory Testing (QST)

Secondary outcome:

Heat Pain Threshold

Heat Pain Tolerance

Temporal Pain Summation

Detecting Diffuse Noxious Inhibitory Control (DNIC)

Heat Sensation

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

MGH Center for Translational Pain Research, Phone: 617-724-6102, Email: mghpainresearch@partners.org

MGH Center for Translational Pain Research, Boston, Massachusetts 02114, United States; Recruiting
MGH Center for Translational Pain Research, Phone: 617-724-6102, Email: mghpainresearch@partners.org
Jianren Mao, M.D., Ph.D., Principal Investigator
Additional Information

MGH Center for Translational Pain Research

Starting date: September 2014
Last updated: September 12, 2014

Page last updated: August 23, 2015

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