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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

Must not have

Has taken Methadone, Suboxone, Fentanyl, and/or Tramadol in the last six (6) months

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used Methadone, Suboxone, Fentanyl, or Tramadol in the past 6 months.

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My chronic pain from conditions like fibromyalgia or arthritis is more intense than my back or neck pain.

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I am taking medication for high blood pressure that causes low blood pressure or slow heart rate.

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I have not been hospitalized for major psychiatric disorders in the past 6 months.

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I am currently in a program for substance abuse or taking medication for addiction or ADHD.

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I have a serious heart, liver, kidney, brain, or metabolic condition.

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I experience numbness or tingling in certain areas of my body.

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I cannot sign the consent form by myself due to my condition.

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I have been diagnosed with Raynaud's syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantitative Sensory Testing (QST)

Secondary study objectives

Detecting Diffuse Noxious Inhibitory Control (DNIC)

Heat Pain Threshold

Heat Pain Tolerance

+2 more

Trial 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: 1. guanfacine (2mg) 2. guanfacine (1mg) 3. 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: 1. guanfacine (2mg) 2. guanfacine (1mg) 3. 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: 1. guanfacine (2mg) 2. guanfacine (1mg) 3. placebo Subjects will be instructed to take one capsule in the evening for 4 weeks.

0 / 13Eligibility criteria met