Status:
TERMINATED
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Combination of guanfacine with opioid medication as a standard treatment for chronic pain.
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 Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02192398
Start Date
September 1 2014
End Date
October 1 2022
Last Update
November 6 2025
Active Locations (1)
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1
MGH Center for Translational Pain Research
Boston, Massachusetts, United States, 02114