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

NCT02192398 | Terminated DMC

• 2 other identifiers: 2014P-0013771R01DA036564-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Pain; Pain management; Neck; Back

Outcome Measures

Primary Outcomes (1)

• Quantitative Sensory Testing (QST)

  Quantitative Sensory Testing (QST) results will be used to compare the 3 treatment groups.

  4 weeks

Secondary Outcomes (5)

• Heat Pain Threshold

  4 weeks

• Heat Pain Tolerance

  4 weeks

• Temporal Pain Summation

  4 weeks

• Detecting Diffuse Noxious Inhibitory Control (DNIC)

  4 weeks

• Heat Sensation

  4 weeks

Study Arms (3)

Guanfacine (2mg)

ACTIVE COMPARATOR

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.

Drug: Guanfacine

Guanfacine (1mg)

ACTIVE COMPARATOR

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.

Drug: Guanfacine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Guanfacine DRUG

Subjects will be randomized into 1 of the following 3 treatment groups: 1. guanfacine (2mg) 2. guanfacine (1mg) 3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).

Also known as: Tenex, Intuniv

Guanfacine (1mg); Guanfacine (2mg)

Placebo DRUG

Subjects will be randomized into 1 of the following 3 treatment groups: 1. guanfacine (2mg) 2. guanfacine (1mg) 3. placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo).

Also known as: Placebo, sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Chronic neck or back pain condition for at least 6 months
• 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

You may not qualify if:

• Has taken Methadone, Suboxone, Fentanyl, and/or Tramadol in the last six (6) months
• Has taken guanfacine (or other alpha-2AR agonists) in the last six (6) months
• Changes to current or adding new pain treatment while enrolled in the study (i.e. opiates, epidural steroid injection) will be reviewed by the study physician
• Unable to independently provide informed written consent
• Sensory deficits at site of QST, such as peripheral neuropathy
• Intolerable allergies or has had a severe adverse reaction to study medication (i.e. guanfacine, lactose, vitamin B2 a.k.a. riboflavin)
• Takes vitamin B2 \> 1.6mg/day during the study
• Pregnant or breastfeeding
• Pending litigation related to neck or back pain
• 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 severe cardiovascular disease (i.e. arrhythmia - prolonged QT interval \> 440ms), cerebrovascular disease/accident (i.e., stroke), 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) will be reviewed by a study physician
• Bradycardia (resting heart rate \< 60 bpm) will be reviewed by a study physician
• Subjects are on antihypertensive drugs (e.g., a beta-blocker) that result in hypotension and/or bradycardia as defined above

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

Related Links

• MGH Center for Translational Pain Research

MeSH Terms

Conditions

Chronic Pain; Pain; Agnosia

Interventions

Guanfacine; Sugars

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Carbohydrates

Study Officials

• Jianren Mao, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)