Not provided
Not provided
Not provided
Not provided
Not provided
Low enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. One group will undergo the standard opioid weaning process and the other group will have the addition of the NADA Protocol to the weaning process.
The NADA (National Acupuncture Detoxification Association) Protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). The NADA Protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation & recovery maintenance. It is also commonly used for PTSD and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain.
It is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. Given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication management & NADA Protocol | Experimental | Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly |
|
| Medication management | Active Comparator | Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NADA Protocol | Procedure | NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal | time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Off-opioids rate | time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months) | |
| Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heather Jackson, MSN, APRN-BC | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33912273 | Derived | Jackson HJ, Walters J, Raman R. Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study. Med Acupunct. 2021 Apr 1;33(2):153-158. doi: 10.1089/acu.2020.1450. Epub 2021 Apr 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Medication management | Other | Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens. |
|
| 9 months |
| Time to cessation of opioids | time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months) |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |