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

NCT01681264 | Terminated Phase 4 DMC

• 2 other identifiers: 2013P-0015101R01DA036564-01
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Pain; Pain Management; Back pain; Neck pain

Outcome Measures

Primary Outcomes (1)

• Quantitative Sensory Testing (QST)

  Quantitative Sensory Testing (QST) results will be used to compare the 5 treatment groups.

  12 weeks

Secondary Outcomes (5)

• Heat Pain Threshold

  12 weeks

• Heat Pain Tolerance

  12 weeks

• Temporal Pain Summation

  12 weeks

• Detecting Diffuse Noxious Inhibitory Control (DNIC)

  12 weeks

• Heat Sensation

  12 weeks

Study Arms (5)

Morphine:Placebo

ACTIVE COMPARATOR

Drug: Morphine; Drug: Placebo

Morphine:Guanfacine 1mg

ACTIVE COMPARATOR

Drug: Morphine; Drug: Guanfacine 1mg

Morphine:Guanfacine 2mg

ACTIVE COMPARATOR

Drug: Morphine; Drug: Guanfacine 2mg

Placebo:Guanfacine 2mg

ACTIVE COMPARATOR

Drug: Guanfacine 2mg; Drug: Placebo

Placebo:Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Morphine DRUG

Also known as: MS Contin

Morphine:Guanfacine 1mg; Morphine:Guanfacine 2mg; Morphine:Placebo

Guanfacine 1mg DRUG

Also known as: Intuniv, Tenex

Morphine:Guanfacine 1mg

Guanfacine 2mg DRUG

Also known as: Intuniv, Tenex

Morphine:Guanfacine 2mg; Placebo:Guanfacine 2mg

Placebo DRUG

Also known as: Sugar Pill

Morphine:Placebo; Placebo:Guanfacine 2mg; Placebo: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 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

You may not qualify if:

• 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)
• Subjects are on antihypertensive drugs (e.g., a beta-blocker) that result in hypotension and/or bradycardia as defined above
• Tests positive for non-study opioids, illicit drugs, marijuana, or non-prescribed drugs
• Major psychiatric disorders that required hospitalization in the past 6 months such as: major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorders
• Currently in a treatment program for alcohol or drug abuse, or currently on methadone or buprenorphine (i.e. suboxone, subutex) for treatment of addiction, or stimulants for treatment of ADHD
• History of substance or alcohol abuse (meets DSM IV criteria) per medical record or subject admission

Sponsors & Collaborators

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

Study Sites (1)

Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

Related Links

• Center for Translational Pain Research

MeSH Terms

Conditions

Chronic Pain; Pain; Agnosia; Back Pain; Neck Pain

Interventions

Morphine; 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)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; 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: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)