Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)
  • 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
  • Subjects are on medications that serve as CYP3A4/5 inhibitors or CYP3A4 inducers including, but are not limited to, valproic acid, macrolide antibiotics, antifungal drugs, St. John wort, ACE inhibitors, nefazodone (antidepressant), calcium channel blockers, H2-receptor antagonists, anti-HIV or AIDS drugs, and antiepileptic drugs
  • Subjects are on medications that are ligands for alpha2-adrenergic receptors including antipsychotic drugs (e.g. clozapine) and tricyclic or tetracyclic antidepressants (e.g. imipramine, mirtazapine, mianserin). Any medications taken by a subject at the enrollment will be reviewed regarding their compatibility with guanfacine and morphine as well as possible confounding side effects. In addition, subjects will be warned of side effects of morphine such as sedation, respiratory depression at the enrollment. Subjects will be allowed to take non-opioid pain medications except for gabapentinoids and amitriptyline/nortriptyline as far as such medications do not have incompatibility with morphine and guanfacine.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Morphine:Placebo
  • Drug: Morphine
    Other names:
    • MS Contin
  • Drug: Placebo
    Other names:
    • Sugar Pill
Active Comparator
Morphine:Guanfacine 1mg
  • Drug: Morphine
    Other names:
    • MS Contin
  • Drug: Guanfacine 1mg
    Other names:
    • Intuniv
    • Tenex
Active Comparator
Morphine:Guanfacine 2mg
  • Drug: Morphine
    Other names:
    • MS Contin
  • Drug: Guanfacine 2mg
    Other names:
    • Intuniv
    • Tenex
Active Comparator
Placebo:Guanfacine 2mg
  • Drug: Guanfacine 2mg
    Other names:
    • Intuniv
    • Tenex
  • Drug: Placebo
    Other names:
    • Sugar Pill
Placebo Comparator
Placebo:Placebo
  • Drug: Placebo
    Other names:
    • Sugar Pill

Recruiting Locations

Center for Translational Pain Research
Boston, Massachusetts 02114
Contact:
Sarah Roth, B.S
617-724-6102
sroth3@mgh.harvard.edu

More Details

NCT ID
NCT01681264
Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Sarah Roth, BS
617-724-6102
sroth3@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.