Chronic Pain
Conditions
Keywords
Pain, Pain management, Neck, Back
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.
Interventions
DRUGGuanfacine
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).
DRUGPlacebo
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).
Sponsors
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 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
Exclusion criteria
* 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 * Tests positive for 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 currently prescribed 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 as well as possible confounding side effects. 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 guanfacine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain) | baseline and 4 weeks | Changes in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJianren Mao, M.D., Ph.D.
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 34 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 4 | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 1 |
Outcome results
None listed