Chronic Pain Clinical Trial
Official title:
SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.
Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities. ;
| 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 |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| 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
|