Acupuncture for Post-Traumatic Stress in Combat Veterans

PTSD Clinical Trial

Official title:

Acupuncture for Post-Traumatic Stress in Combat Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871076
• Other study ID #: PR151974
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2020
• Source: Southern California Institute for Research and Education
• Contact: Kala Carrick, MS
• Phone: 562-826-8000
• Email: kala.harkin[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

1. Any witnessed apnea

2. Feeling non-refreshed in the morning =50 of mornings

3. 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

Related Conditions & MeSH terms

• Acupuncture
• Combat
• PTSD

Intervention

Device:
• Acupuncture
Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.

Locations

Country	Name	City	State
United States	Veterans Affairs Long Beach Healthcare System	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis		4 months: Baseline CAPS to post treatment