Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (NCT01681264) | Clinical Trial Compass
TerminatedPhase 4
Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance
Stopped: End of NIH funding
United States137 participantsStarted 2014-09
Plain-language summary
Dual medication (guanfacine and morphine) 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 3 months
* VAS score of 4-8
* Has not taken an opioid for the last 3 months
* Has not taken guanfacine (or other alpha-2AR agonists) for the last 6 months
Exclusion Criteria
* Sensory deficits at site of QST, such as peripheral neuropathy
* Allergic to or has had a severe adverse reaction to study medication (i.e. opioids, guanfacine, lactose, vitamin B2 a.k.a. riboflavin)
* Cannot tolerate study drugs' maximum doses
* Takes vitamin B2 \> 1.6mg/day during the study
* Pregnant or breastfeeding
* Pending litigation
* 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 cardiovascular disease (i.e. arrhythmia - prolonged QT interval \> 440ms), cerebrovascular disease, 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) or bradycardia (resting heart rate \< 60 bpm)
* Subjects are on antihypertensive drugs (e.g., a beta-blocker) that result in hypotension and/or bradycardia as defined above
* Tests positive for non-study opioids, illicit drugs, marijuana, or non-prescribed drugs
* Major psychiatric disorders that required hospitalization in the past …