Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (NCT02192398) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
Stopped: End of NIH funding
United States8 participantsStarted 2014-09
Plain-language summary
Combination of guanfacine with opioid medication as a standard treatment for chronic pain.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 D…