Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)

Not Applicable

Active, not recruiting

• Conditions: Chronic Pain
• Interventions: Drug: Guanfacine; Drug: Placebo

• Registration Number: NCT02192398
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Combination of guanfacine with opioid medication as a standard treatment for chronic pain.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Study Start: 2014-09
• Primary Completion: 2022-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guanfacine (1mg)	Guanfacine	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.
Placebo	Placebo	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.
Guanfacine (2mg)	Guanfacine	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.

Primary Outcome Measures

Name	Time	Method
Quantitative Sensory Testing (QST)	4 weeks	Quantitative Sensory Testing (QST) results will be used to compare the 3 treatment groups.

Secondary Outcome Measures

Name	Time	Method
Heat Sensation	4 weeks	Subjects will be measured for their heat sensation using QST. The testing will be done at 3 of the 4 visits.
Heat Pain Threshold	4 weeks	Subjects will be measured for their heat pain threshold using QST. The testing will be done at 3 of the 4 visits.
Heat Pain Tolerance	4 weeks	Subjects will be measured for their heat pain tolerance using QST. The testing will be done at 3 of the 4 visits.
Temporal Pain Summation	4 weeks	Subjects will be measured for their temporal pain summation using QST. The testing will be done at 3 of the 4 visits.
Detecting Diffuse Noxious Inhibitory Control (DNIC)	4 weeks	Subjects will be measured for their Diffuse Noxious Inhibitory Control (DNIC). The testing will be done at 3 of the 4 visits.

Trial Locations

Locations (1)

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