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

Phase 4

Active, not recruiting

• Conditions: Chronic Pain
• Interventions: Drug: Placebo; Drug: Morphine; Drug: Guanfacine 2mg; Drug: Guanfacine 1mg

• Registration Number: NCT01681264
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Study Start: 2013-11
• Primary Completion: 2022-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Morphine:Guanfacine 2mg	Guanfacine 2mg	-
Placebo:Placebo	Placebo	-
Morphine:Placebo	Morphine	-
Placebo:Guanfacine 2mg	Guanfacine 2mg	-
Morphine:Guanfacine 1mg	Guanfacine 1mg	-
Morphine:Placebo	Placebo	-
Placebo:Guanfacine 2mg	Placebo	-
Morphine:Guanfacine 1mg	Morphine	-
Morphine:Guanfacine 2mg	Morphine	-

Primary Outcome Measures

Name	Time	Method
Quantitative Sensory Testing (QST)	12 weeks	Quantitative Sensory Testing (QST) results will be used to compare the 5 treatment groups.

Secondary Outcome Measures

Name	Time	Method
Heat Pain Tolerance	12 weeks	Subjects will be measured for their heat pain tolerance using Quantitative Sensory Testing (QST). The testing will be done at 5 of the 6 visits.
Temporal Pain Summation	12 weeks	Subjects will be measured for their temporal pain summation using Quantitative Sensory Testing (QST). The testing will be done at 5 of the 6 visits.
Detecting Diffuse Noxious Inhibitory Control (DNIC)	12 weeks	Subjects will be measured for their Diffuse Noxious Inhibitory Control (DNIC). The testing will be done at 5 of the 6 visits.
Heat Pain Threshold	12 weeks	Subjects will be measured for their heat pain threshold using Quantitative Sensory Testing (QST). The testing will be done at 5 of the 6 visits.
Heat Sensation	12 weeks	Subjects will be measured for their heat sensation using Quantitative Sensory Testing (QST). The testing will be done at 5 of the 6 visits.

Trial Locations

Locations (1)

Center for Translational Pain Research; 🇺🇸 Boston, Massachusetts, United States