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Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

NCT05132699 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-10

Study results available
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Summary

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

Conditions

Interventions

DRUG

Cannabidiol (CBD) oral solution

An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day

DRUG

Placebo

An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day

BEHAVIORAL

Massed Prolonged Exposure (mPE)

mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Casey Straud, PsyD · University of Texas Health Science Center San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132699 on ClinicalTrials.gov