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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Chronic Pain

In brief

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

Key facts

Study ID: NCT02192398
Run by: Massachusetts General Hospital
People needed: 8
Starts: 2014-09-01
Expected to finish: 2022-10-01
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

MGH Center for Translational Pain Research — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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