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Alpha-2 Adrenergic Agonist
Guanfacine for Hyperalgesia
Phase 4
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial suggests that a dual medication approach of guanfacine and morphine may be a more effective treatment for chronic pain than either medication alone.
Eligible Conditions
- Chronic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Morphine:Guanfacine 1mgActive Control2 Interventions
Group II: Placebo:Guanfacine 2mgActive Control2 Interventions
Group III: Morphine:PlaceboActive Control2 Interventions
Group IV: Morphine:Guanfacine 2mgActive Control2 Interventions
Group V: Placebo:PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,160 Total Patients Enrolled
30 Trials studying Chronic Pain
4,813 Patients Enrolled for Chronic Pain
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,559 Total Patients Enrolled
26 Trials studying Chronic Pain
22,795 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,348 Total Patients Enrolled
64 Trials studying Chronic Pain
84,374 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to handle the highest amount of the study drugs.Your blood pressure is too low, or your resting heart rate is too slow.You have other types of long-lasting pain, like fibromyalgia or joint arthritis, that are worse than your back and neck pain.You have been hospitalized for major mental health conditions like depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorders in the past 6 months.You have a history of drug or alcohol abuse according to medical records or your own admission.You are currently receiving treatment for alcohol or drug abuse, or taking specific medications for addiction or ADHD.You have trouble feeling things in the area where the test will be done.You are taking certain medications for mental health or pain that may interact with the study drugs. Your current medications will be checked for compatibility and potential side effects. You will also be informed about the side effects of the study drug morphine. You can take non-opioid pain medications, except for specific ones, as long as they do not interact with the study drugs.You are between 18 and 65 years old.You have had ongoing neck or back pain for at least 3 months.Your pain score is between 4 and 8 on a scale of 0 to 10.You have not used any opioid medications for the past 3 months.You are taking certain medications that affect how other drugs work in your body.You have a known heart, brain, liver, or kidney condition, or a history of fainting.You are taking more than 1.6mg of vitamin B2 per day during the study.You have been diagnosed with Raynaud's syndrome.You are taking high blood pressure medication that can cause low blood pressure or slow heart rate.You have tested positive for drugs that are not allowed in the study, like illegal drugs or medications that were not prescribed to you.You have not taken guanfacine or similar medications for the past 6 months.You are allergic to or have had a severe reaction to the study medication, such as opioids, guanfacine, lactose, or vitamin B2 (riboflavin).
Research Study Groups:
This trial has the following groups:- Group 1: Morphine:Guanfacine 1mg
- Group 2: Placebo:Guanfacine 2mg
- Group 3: Placebo:Placebo
- Group 4: Morphine:Placebo
- Group 5: Morphine:Guanfacine 2mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Chronic Pain Patient Testimony for trial: Trial Name: NCT01681264 — Phase 4
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