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Alpha-2 Adrenergic Agonist
Guanfacine for Hyperalgesia
N/A
Waitlist Available
Led By Jianren Mao, M.D., Ph.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial suggests that combining guanfacine with opioids may be a more effective treatment for chronic pain than opioids alone.
Who is the study for?
Adults aged 18-65 with chronic neck or back pain for at least 6 months, experiencing moderate to severe pain despite opioid treatment, and on a stable opioid dose. Excluded are those with substance abuse history, recent use of certain drugs like Methadone or Fentanyl, severe allergies to study meds, cardiovascular issues, pregnant/breastfeeding women, and those on conflicting medications.Check my eligibility
What is being tested?
The trial is testing whether Guanfacine can reverse Opioid-induced Hyperalgesia in people with chronic pain who are already taking opioids. Participants will either receive Guanfacine or a placebo alongside their standard opioid medication.See study design
What are the potential side effects?
Guanfacine may cause side effects such as drowsiness, dry mouth, constipation and low blood pressure. It might also slow down the heart rate which could be significant for individuals with pre-existing heart conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have moderate to severe pain despite taking painkillers.
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I have been on a stable pain medication dose for 3 months.
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I have had chronic neck or back pain for at least 6 months.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitative Sensory Testing (QST)
Secondary outcome measures
Detecting Diffuse Noxious Inhibitory Control (DNIC)
Heat Pain Threshold
Heat Pain Tolerance
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Guanfacine (1mg)Active Control1 Intervention
Subjects will be randomized into 1 of the following 3 treatment groups:
guanfacine (2mg)
guanfacine (1mg)
placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Group II: Guanfacine (2mg)Active Control1 Intervention
Subjects will be randomized into 1 of the following 3 treatment groups:
guanfacine (2mg)
guanfacine (1mg)
placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Subjects will be randomized into 1 of the following 3 treatment groups:
guanfacine (2mg)
guanfacine (1mg)
placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
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13,198,235 Total Patients Enrolled
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National Institutes of Health (NIH)NIH
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22,728 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,473 Total Patients Enrolled
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82,380 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used Methadone, Suboxone, Fentanyl, or Tramadol in the past 6 months.My chronic pain from conditions like fibromyalgia or arthritis is more intense than my back or neck pain.I am taking medication for high blood pressure that causes low blood pressure or slow heart rate.I have not been hospitalized for major psychiatric disorders in the past 6 months.I am currently in a program for substance abuse or taking medication for addiction or ADHD.You have a history of drug or alcohol abuse as diagnosed by a doctor or admitted by you.I have a serious heart, liver, kidney, brain, or metabolic condition.I still have moderate to severe pain despite taking painkillers.I am taking certain medications that affect my brain's messaging system.I am currently taking medication that affects how my body processes drugs.Any new pain treatments I start during the study will be checked by the study doctor.I experience numbness or tingling in certain areas of my body.I have been on a stable pain medication dose for 3 months.You are currently involved in a lawsuit related to neck or back pain.I have had chronic neck or back pain for at least 6 months.I cannot sign the consent form by myself due to my condition.I am between 18 and 65 years old.You have tested positive for illegal drugs, marijuana, or drugs not prescribed by a doctor.You have had a serious allergic reaction to the study medication or any of its ingredients.I have taken guanfacine or similar medications in the past 6 months.If your blood pressure is too low when you are sitting, a study doctor will check it.I have been diagnosed with Raynaud's syndrome.You take more than 1.6mg of vitamin B2 per day during the study.Your resting heart rate is less than 60 beats per minute.
Research Study Groups:
This trial has the following groups:- Group 1: Guanfacine (1mg)
- Group 2: Placebo
- Group 3: Guanfacine (2mg)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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