Chronic PainPhase 4NCT03397212
Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients
A Phase 4 study testing NADA acupuncture in people with Chronic Pain and Opiate Withdrawal Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This project aims at examining the following hypotheses: Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine. Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opiate Withdrawal Syndrome
- What is being tested?
- NADA acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2018to 15 Jan 2024
- Phase
- Phase 4
- 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
- Chronic pain patients treated with opioids over 3 months
- The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
- The patient is motivated for opioid withdrawal
- The patient has experienced withdrawal symptoms
- The patient must be able to understand, speak and write Danish
- The patient must be able to transport himself to the pain center
Who cannot join
- Children under 18 years old
- External ear infection
- Treatment with benzodiazepines.
- Active substance abuse and alcohol abuse.
- Contraindications for treatment with clonidine:
- Allergy
Show all 12Show fewer
- Bradyarrhythmias caused by diseased sinus cube or AV block of 2nd or 3rd grade.
- lactose intolerance
- Heart failure
- High medullary damage
- Cardiac conduction disturbances
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
This project aims at examining the following hypotheses:
- Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
- Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.
- Conditions
- Chronic Pain, Opiate Withdrawal Syndrome
- Being tested
- NADA acupuncture, Sham acupuncture
- Keywords
- NADA
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NADA acupunctureOther
Ear acupuncture protocol described by National Acupuncture Detoxification Association
Sham acupunctureOther
Ear acupuncture using inactive sham points
| Study group | Role | What they receive |
|---|---|---|
| NADA and Clonidine | Experimental | NADA acupuncture and treatment with tbl Clonidine Receives: Other: NADA acupuncture |
| Sham acupuncture and Clonidine | Sham comparator | Sham ear acupuncture and treatment with tbl Clonidine Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of withdrawal symptoms
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
Measured: 3 months and 1 year
Secondary outcomes (1)
Change in quality of life assessed with SF36
Change in quality of life assessed with SF36
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start15 Jan 2018 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romanas Polianskis, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397212
- Sponsor's protocol ID
- 59065
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03397212
- Acronym / sponsor ID
- 59065
- Conditions
- Chronic Pain, Opiate Withdrawal Syndrome
- Keywords
- NADA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 11 Jan 2018 (actual)
- 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 project aims at examining the following hypotheses:
- Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
- Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NADA and Clonidine | Experimental | Other: NADA acupunctureNADA acupuncture and treatment with tbl Clonidine |
| Sham acupuncture and Clonidine | Sham comparator | Other: Sham acupunctureSham ear acupuncture and treatment with tbl Clonidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic pain patients treated with opioids over 3 months
- The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
- The patient is motivated for opioid withdrawal
- The patient has experienced withdrawal symptoms
- The patient must be able to understand, speak and write Danish
Key exclusion criteria (12 listed)
- Children under 18 years old
- External ear infection
- Treatment with benzodiazepines.
- Active substance abuse and alcohol abuse.
- Contraindications for treatment with clonidine:
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 acupunctureEar acupuncture protocol described by National Acupuncture Detoxification Association | Other | NADA and Clonidine |
| Sham acupunctureEar acupuncture using inactive sham points | Other | Sham acupuncture and Clonidine |
Primary outcome
Change in intensity of withdrawal symptoms
Time frame: 3 months and 1 year
Change in intensity of withdrawal symptoms assessed with Danish withdrawal symptom questionnaire
1 secondary outcome
Change in quality of life assessed with SF36
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NADA acupuncture in people with Chronic Pain and Opiate Withdrawal Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Jan 2018. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romanas Polianskis, MD (+45 35455233, romanas.polianskis@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intensity of withdrawal symptoms (time frame: 3 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2018.