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Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

NCT05632627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-12-17

No results posted yet for this study

Summary

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and traumatic brain injury-related symptoms. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

Conditions

  • Brain Injuries, Traumatic

Interventions

DRUG

Cannabidiol

The current study will directly test the hypothesis that a moderate dose of CBD leads to improvements in cognition, TBI-related symptoms, pain, sleep, depression, anxiety, and peripheral markers of inflammation and oxidative stress.

DRUG

Placebo

Placebo arm

Sponsors & Collaborators

  • Colorado State University

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2025-07-07
Completion
2025-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05632627 on ClinicalTrials.gov