Opioid-use Disorder Clinical Trial
Official title:
Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
| Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
| Completed |
NCT04505540 -
Start Treatment and Recovery for Opioid Use Disorder
|
N/A | |
| Completed |
NCT03065049 -
Transforming Recovery Through Exercise and Community
|
N/A | |
| Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
| Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
| Suspended |
NCT05001789 -
Cognitive Functioning in Opioid Use Disorder
|
N/A | |
| Active, not recruiting |
NCT04650386 -
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
|
N/A | |
| Completed |
NCT03715634 -
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
|
Phase 1 | |
| Enrolling by invitation |
NCT04991974 -
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
|
Phase 2/Phase 3 | |
| Completed |
NCT04122755 -
Single Ascending Dose Study of ALA-1000
|
Phase 1 | |
| Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
| Recruiting |
NCT05028998 -
COVID-19-Related Opioid Treatment Policy Evaluation
|
||
| Recruiting |
NCT05049460 -
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
|
N/A | |
| Completed |
NCT05047627 -
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
|
N/A | |
| Active, not recruiting |
NCT04129580 -
reSET-O RCT (Randomized Controlled Trial)
|
N/A | |
| Recruiting |
NCT03923374 -
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
|
||
| Completed |
NCT04464421 -
SMART Effectiveness Trial
|
N/A | |
| Suspended |
NCT02687360 -
Imaging the Effects of rTMS on Chronic Pain
|
N/A | |
| Completed |
NCT04056182 -
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
|
Phase 2 |