Acupuncture for Post-Traumatic Stress in Combat Veterans

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 30, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Verum Acupuncture
    • Patients will receive verum acupuncture twice weekly for twelve weeks.
  • Placebo Comparator: Sham Placebo Acupuncture
    • Patients will receive sham placebo acupuncture twice weekly for twelve weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
    • Time Frame: 4 months: Baseline CAPS to post treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Southern California Institute for Research and Education
  • Collaborator
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael Hollifield, MD, Director, Program for Traumatic Stress – Southern California Institute for Research and Education
  • Overall Official(s)
    • Michael Hollifield, MD, Principal Investigator, Tibor Rubin VA Medical Center
  • Overall Contact(s)
    • Kala Carrick, MS, 562-826-8000, kala.harkin@va.gov

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