Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04550377
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol — DRUG
    The drug product to be used in this study is an oral formulation of CBD
  • Placebo — DRUG
    non-active medication

Study Details

This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI). There will be three study arms, each with 40 subjects: 1) Oral CBD 400 mg daily; 2) Oral CBD 800 mg daily, and 3) Placebo daily. Treatment duration will be 8 weeks. The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score.

Key Dates

Start date
May 26, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cannabidiol Group 1
    40 participants will be titrated to a maximum dose of oral cannabidiol 800 mg daily over 2 weeks for a total of 8 weeks treatment.
  • Active Comparator: Cannabidiol Group 2
    40 participants will be titrated to a maximum dose of oral cannabidiol 400 mg daily over 2 weeks for a total of 8 weeks treatment.
  • Placebo Comparator: Placebo Group
    40 participants will be given a placebo for a total of 8 weeks treatment.

Primary Outcome Measure

Change in PTSD symptoms [ Time Frame: Baseline, Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016
Esther M Blessing, MD PhD
[email protected]
646-754-4808
Natalie Saba, BSc.
[email protected]

Find similar trials in New York, NY

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
New York University School of Medicine· New York, NY

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