PTSDNCT02871076
Acupuncture for Post-Traumatic Stress in Combat Veterans
A study testing Acupuncture in people with PTSD and Acupuncture, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Acupuncture, Combat
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2018to 31 Mar 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Veteran Age 18 to 55
- DSM-5 criteria for chronic PTSD on Clinical Administered PTSD Scale (CAPS-5)
- CAPS-5 score of ≥ 26 and meeting criteria for each of 4 symptoms
Who cannot join
- Current and past six-months psychosis
- Substance dependence within 6 months (evidence of tolerance and/or withdrawal)
- Thyroid disease
- Decisional incapacity (e.g., dementia)
- Centrally acting medications that have a potential effect on biological expression (e.g., beta-blockers, opiates, and ≥10mg equivalent of diazepam/day)
- Pain levels requiring opiate medications
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- Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae
- Severe depression (Beck Depression Inventory-II score ≥30)
- A diagnosed and untreated sleep breathing disorder (SBD)
- High risk of a SBD as indicated by snoring ≥50 of nights plus one of any
- Any witnessed apnea
- Feeling non-refreshed in the morning ≥50 of mornings
- Daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
- Non-response to ≥2 evidence-based PTSD treatments (adequate medication of 12 weeks or completion to PE, CPT or an intensive program)
- Treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of PTSD EBT
- High dissociation as indicated by a score of ≥25 on the Dissociative Experiences Scale - II
- Past chronic PTSD prior to military service
- Current active psychotherapy for PTSD
- Having acupuncture in the past year
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Long Beach Healthcare System
Long Beach, California, 90822
Kala Carrick, MA, 562-826-8000 ext. 7212, kala.harkin@va.gov
Michael Hollifield, MD
About this study
The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.
- Conditions
- PTSD, Acupuncture, Combat
- Being tested
- Acupuncture
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Verum Acupuncture | Experimental | Patients will receive verum acupuncture twice weekly for twelve weeks. Receives: Device: Acupuncture |
| Sham Placebo Acupuncture | Placebo comparator | Patients will receive sham placebo acupuncture twice weekly for twelve weeks. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
Measured: 4 months: Baseline CAPS to post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start19 May 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Michael Hollifield, MD, Southern California Institute for Research and Education
- Investigators
- Michael Hollifield, MD, Principal investigator, Tibor Rubin VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871076
- Sponsor's protocol ID
- PR151974
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2016
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Post-Traumatic Stress in Combat Veterans
- ClinicalTrials.gov ID
- NCT02871076
- Acronym / sponsor ID
- PR151974
- Conditions
- PTSD, Acupuncture, Combat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 19 May 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 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.
The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Acupuncture | Experimental | Device: AcupuncturePatients will receive verum acupuncture twice weekly for twelve weeks. |
| Sham Placebo Acupuncture | Placebo comparator | Device: AcupuncturePatients will receive sham placebo acupuncture twice weekly for twelve weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Veteran Age 18 to 55
- DSM-5 criteria for chronic PTSD on Clinical Administered PTSD Scale (CAPS-5)
- CAPS-5 score of ≥ 26 and meeting criteria for each of 4 symptoms
Key exclusion criteria (20 listed)
- Current and past six-months psychosis
- Substance dependence within 6 months (evidence of tolerance and/or withdrawal)
- Thyroid disease
- Decisional incapacity (e.g., dementia)
- Centrally acting medications that have a potential effect on biological expression (e.g., beta-blockers, opiates, and ≥10mg equivalent of diazepam/day)
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 |
|---|---|---|
| AcupuncturePatients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture. | Device | Sham Placebo Acupuncture, Verum Acupuncture |
Primary outcome
Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
Time frame: 4 months: Baseline CAPS to post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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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.
Michael Hollifield, MD principal investigator
Tibor Rubin VA 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 Acupuncture in people with PTSD and Acupuncture, run by Southern California Institute for Research and Education 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 3 inclusion and 20 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 8 Apr 2020. 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. 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.
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 Kala Carrick, MS (562-826-8000 ext. 7212, kala.harkin@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis (time frame: 4 months: Baseline CAPS to post treatment). 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 8 Apr 2020.