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TERMINATEDPHASE4

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

NCT01681264•Massachusetts General Hospital

Summary

Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.

Detailed Description

This aim proposes that guanfacine would be a useful drug to deter Opioid-Induced Hyperalgesia (OIH) when combined with an opioid (morphine) in chronic pain management.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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)
+7 more criteria

Locations (1)

Center for Translational Pain Research

Boston, Massachusetts, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2023

Last Updated

November 6, 2025

Enrollment

200

ESTIMATED participants

Conditions

Chronic Pain

Interventions

Morphine

DRUG

Guanfacine 1mg

DRUG

Guanfacine 2mg

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

Inclusion Criteria

Exclusion Criteria

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