Chronic Pain Clinical Trial
Official title:
Patient-Centered Opioid Tapering in Outpatients With Chronic Pain and Long-Term Opioid Use
This is an observational study of a voluntary opioid tapering protocol conducted in community outpatients taking long term prescription opioids for chronic pain. Patients who would otherwise continue with their existing opioid prescriptions were encouraged to participate in a voluntary opioid taper program. Interested patients were identified by their pain physician, Dr. Richard Stieg, and then completed an online informed consent document and baseline self-report assessments including types and doses of opioid medications as well as demographic and psychosocial measures, clinical and pain characteristics. Patients were either given or mailed a free copy of a patient book The Opioid-Free Pain Relief Kit, or Less Pain, Fewer Pills: Avoid the dangers of prescription opioids and gain control over chronic pain. Over the following weeks and up to 4 months, Dr. Stieg implemented a slow, individually tailored opioid taper in all patient participants. Follow-up online self-report surveys were completed at 4 months post enrollment. Opioid dose data were confirmed via medical chart review, and doses were converted to a standardized morphine equivalent daily dose (MEDD). Main outcome was change in opioid dose baseline to 4 months. Secondary outcome was change in pain intensity (numeric rating scale, 0-10) baseline to 4 months.
Background: Background: An estimated 11 million Americans were prescribed long term opioids
in 2014—up to 4 percent of the entire U.S. adult population. Patients with chronic pain
taking long term opioids are at higher risk for multiple health problems including more
severe pain and addiction, and death from accidental overdose. Opioid related overdoses are
now a leading cause of death in the U.S. Multiple national agencies have called for reduced
opioid prescriptions.
Lower doses of opioids are safer for patients. Patients who take very high dose opioids for
chronic pain (>200 morphine equivalent daily dose; MEDD) are at 3-fold increased risk for
accidental overdose death compared to those on low doses (1). However, the primary patient
concern about reducing opioids is fear of having increased pain. Indeed, evidence is lacking
for how to help real-world patients with chronic pain reduce opioid use while controlling
their pain.
Inpatient studies suggest that pain improves with intensive pain rehabilitation and opioid
cessation (2). interdisciplinary chronic pain rehabilitation combined with opioid cessation
in veterans has been associated with improved indices of psychological and physical function,
as well as significantly reduced pain in those who stop opioids during the program (3).
However, inpatient and intensive opioid reduction programs are costly and unavailable to most
patients. Recently, researchers conducted an outpatient randomized controlled trial comparing
an outpatient opioid tapering program to usual care (4). The tapering program consisted of
psychiatric consultation, opioid dose tapering, and 18 weekly meetings with a physician
assistant to explore motivation for tapering and learn pain self-management skills.
No studies exist to inform best practice on opioid reduction in primary care or outpatient
pain clinics. There is a critical gap in knowledge on how to help community-based (primary
care and pain clinic) outpatients with chronic pain actively reduce opioids while controlling
pain. This project was intended to inform real-world patient care to specifically help
patients with chronic pain taking long term moderate-, high-, and super high-dose opioids
reduce their daily use and associated risks. The goal is to understand whether a simple,
patient-centered opioid taper conducted with limited resources and no interdisciplinary
supportive treatments (e.g., psychology services, physical therapy) could effectively reduce
opioid dose without increasing pain.
Methods
Study Design: A prospective observational study of a voluntary patient-centered opioid
tapering program. The study was conducted in compliance with the Stanford University's
Internal Review Board.
Participants: Adult patients with chronic pain prescribed opioids from a private practice
pain clinic in Colorado were invited by their prescribing physician to participate in a
voluntary opioid tapering program. Patients who expressed interest were called and invited
into the study (note that the study, which involved collecting patient data, is distinct from
the taper program. Patients could taper their opioids without agreeing to be studied).
Inclusion criteria included adults over the age of 18 years, medically diagnosed chronic pain
for at least 6 months, interest in participating in patient-centered opioid tapering, intact
cognitive function, an absence of frank psychological disorder, able to speak/read English,
able to complete online forms, and not being enrolled in a treatment program for substance
use disorder.
Procedure
Patients from a private clinic with chronic pain using daily opioid medications were invited
to participate in a voluntary opioid taper program by their physician. Those who agreed to
participated were enrolled in the weaning program (taper program) with the physician. After
patients provided informed consent, enrolled patients completed a series of online
questionnaires that collect data on demographics, psychosocial factors, and physical,
emotional, and cognitive function, and opioid medications (type and dose) at baseline and at
4-month follow-up. The opioid taper program was not regulated by the study protocol. It was
supervised by the physician, and individually tailored to meet the patient's specific
clinical needs. The goal was to reduce opioid consumption at a comfortable pace (individually
determined) and target cessation at 4 months from the time they enter the weaning program.
Data Collected:
Demographics included age and gender. Clinical variables included opioid medications, length
of time on opioids, pain diagnoses, pain intensity, and marijuana use (yes/no). Opioids were
converted to a Morphine Equivalent Daily Dose (MEDD) using standard procedures. MEDDs were
calculated for baseline and for the 4 month follow-up time point.
Current Medications Pain Catastrophizing Scale PROMIS Global Health Scale PROMIS Fatigue
Scale PROMIS Pain Interference Scale PROMIS Physical Function Scale PROMIS Emotional
Distress-Anxiety Scale PROMIS Depression Scale PROMIS Sleep Disturbance Scale PROMIS Sleep
Interference PROMIS Pain Behavior Scale PROMIS Social Isolation PROMIS Sleep Related
Impairment Scale PROMIS Cognitive Function Scale PROMIS Pain Intensity PROMIS Applied Cog
Abilities Marijuana use (yes/no)
Analytic Plan:
Descriptive statistics will include means, medians, ranges, frequencies and percentiles for
study variables.
For continuous variables: Welch Two Sample, two-sided t-test without assumption of equal
variance will be used.
Polychotomous variables: Pearson's Chi-squared test with Yates' continuity correction. For
cells with small numbers, P value will be simulated with 2000 replications.
PRIMARY OUTCOME:
Assuming the primary outcome MEDD will not be normally distributed, Kruskal-Wallis rank sum
test will be used to compare MEDD at baseline and 16 weeks.
Pain intensity, our secondary outcome will be assessed similarly.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|
||
Completed |
NCT05036499 -
PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
|
N/A |