Chronic Pain
Conditions
Keywords
Pain, Pain Management, Back pain, Neck pain
Brief summary
Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.
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.
Interventions
DRUGMorphine
DRUGGuanfacine 1mg
DRUGGuanfacine 2mg
DRUGPlacebo
Sponsors
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score | 12 weeks; outcomes were assessed at the baseline and 12 weeks. | Change in numeric pain score (from 0-10: 0 being no pain; 10 being worst pain) was used to measure changes in pain. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJianren Mao, M.D., Ph.D.
Massachusetts General Hospital
Participant flow
Recruitment details
A total of 538 potential study participants were screened, 137 were enrolled, and 51 completed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants |
| Age, Continuous | 28 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 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 | 110 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 | 0 / 28 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 28 | 0 / 29 | 0 / 28 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 0 / 28 | 0 / 26 | 0 / 26 |
Outcome results
None listed