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

TerminatedNot applicableNCT02192398
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
Conditions
Interventions
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH); National Institute on Drug Abuse (NIDA)
Start date
2014-09
Primary completion
2022-10
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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, val…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02192398