Narcotic AddictionNCT02882048
Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
A study testing NADA Protocol and Medication management in people with Narcotic Addiction, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcotic Addiction
- What is being tested?
- NADA Protocol and Medication management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 25 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
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.
Read the detailed description
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.
- Conditions
- Narcotic Addiction
- Being tested
- NADA Protocol, Medication management
- Keywords
- Opioid addiction, Opioid weaning
- Medical subject headings
- Narcotic-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NADA ProtocolProcedure or surgery
Also called National Acupuncture Detoxification Association Protocol
NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled.
Medication managementOther
Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: NADA Protocol; Other: Medication management |
| Medication management | Active comparator | Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens. Receives: Other: Medication management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal
Measured: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
Secondary outcomes (3)
Off-opioids rate
Measured: 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)
Measured: 9 months
Time to cessation of opioids
Measured: time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion14 Jan 2019
- Study completion25 Feb 2019
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narcotic AddictionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Jackson, Vanderbilt University Medical Center
- Investigators
- Heather Jackson, MSN, APRN-BC, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882048
- Sponsor's protocol ID
- 160725
- Status last verified
- Mar 2019
- First submitted
- 24 Aug 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33912273
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
- ClinicalTrials.gov ID
- NCT02882048
- Acronym / sponsor ID
- 160725
- Conditions
- Narcotic Addiction
- Keywords
- Opioid addiction, Opioid weaning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication management & NADA Protocol | Experimental | Procedure: NADA Protocol, Other: Medication managementStandard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly |
| Medication management | Active comparator | Other: Medication managementStandard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 and older
- Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NADA ProtocolAlso: National Acupuncture Detoxification Association ProtocolNADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled. | Procedure or surgery | Medication management & NADA Protocol |
| Medication managementStandard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens. | Other | Medication management, Medication management & NADA Protocol |
Primary outcome
Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal
Time frame: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
3 secondary outcomes
Off-opioids rate
Time frame: 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)
Time frame: 9 months
Time to cessation of opioids
Time frame: time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Derived from this study: PubMed 33912273Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Jackson, MSN, APRN-BC principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NADA Protocol and Medication management in people with Narcotic Addiction, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal (time frame: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.