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Cannabinoid

CBD for Traumatic Brain Injury

Q: Is the enrollment of those over thirty years old accepted for this trial?

The age range for participation in this medical trial is between 18 and 60, as detailed within the inclusion parameters.

Q: Has the Food and Drug Administration accepted Full Spectrum Cannabidiol as a viable therapeutic?

There is limited evidence of safety but no data attesting to efficacy, hence Full Spectrum Cannabidiol received a score of 2.

Q: Are participants being actively sought for this trial?

Per the clinicaltrials.gov portal, this research endeavour is currently recruiting individuals for participation. It was initially published on April 11th 2023 and most recently revised on April 20th of that same year.

Q: What goals are this medical experiment striving to achieve?

The 12-week clinical trial seeks to measure the impact of treatment on Cognition. Secondary goals include assessing changes in Circulating Cytokine Proteins, <a href="https://www.withpower.com/clinical-trials/depression">Depression</a> (as measured by BDI-II), and Quality of Life (measured using SF36).

Q: Is it possible for me to join the trial as a subject?

This clinical trial seeks 120 candidates with <a href="https://www.withpower.com/clinical-trials/traumatic-brain-injury">traumatic brain injury</a> to participate and meet the age criterion of 18-60 years.

Q: How many participants is this research endeavor currently accommodating?

Affirmative, the information hosted on clinicaltrials.gov indicates that this research is still recruiting participants. Initially posted on April 11th 2023, it has since been updated as recently as April 20th and seeks to enrol 120 patients at one medical centre.

Phase 2

Recruiting

Led By Kent Hutchison, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 to week 6, week 0 to week 12

Awards & highlights

Study Summary

This trial will assess if CBD can improve cognition & symptoms related to traumatic brain injury in people. Subjects will be randomly assigned a condition for 12 weeks.

Who is the study for?

This trial is for adults aged 18-60 with mild to moderate traumatic brain injury (TBI) who have been evaluated in a hospital setting. Participants should not be involved in other TBI treatment studies, must have stable treatments for four weeks prior, and cannot change these during the study. Exclusions include severe mental illness, unstable medical conditions, high liver enzymes, current heavy cannabis or CBD use, certain neurological disorders, substance abuse issues, and pregnancy.Check my eligibility

What is being tested?

The study tests two forms of cannabinoids (fsCBD and bsCBD) against a placebo to see if they can improve cognition and symptoms related to TBI. Participants are randomly assigned to one of these options for a duration of 12 weeks in this double-blind trial where neither the researchers nor participants know who receives the actual drug or placebo.See study design

What are the potential side effects?

While specific side effects are not listed here, cannabinoids like fsCBD and bsCBD may cause drowsiness, changes in appetite or mood swings. Some individuals might experience digestive issues or headaches. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 to week 6, week 0 to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 to week 6, week 0 to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 6, week 0 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cognition

Change in Neuropsychiatric Symptoms

Secondary outcome measures

Change in Anxiety

Change in Biomarkers of Inflammation

Change in Biomarkers of Oxidative Stress

+4 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Broad Spectrum CannabidiolActive Control1 Intervention

Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day

Group II: Full Spectrum CannabidiolActive Control1 Intervention

Full Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day

Group III: Hemp Seed OilPlacebo Group1 Intervention

Placebo Oral softgel capsule, 210mg/day

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,406 Total Patients Enrolled

Colorado State UniversityOTHER

125 Previous Clinical Trials

38,239 Total Patients Enrolled

Kent Hutchison, PhDPrincipal Investigatorkent.hutchison@cuanschutz.edu

2 Previous Clinical Trials

601 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05632627 — Phase 2

Traumatic Brain Injury Research Study Groups: Broad Spectrum Cannabidiol, Hemp Seed Oil, Full Spectrum Cannabidiol

Traumatic Brain Injury Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05632627 — Phase 2

Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632627 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of those over thirty years old accepted for this trial?

"The age range for participation in this medical trial is between 18 and 60, as detailed within the inclusion parameters."

Answered by AI

Has the Food and Drug Administration accepted Full Spectrum Cannabidiol as a viable therapeutic?

"There is limited evidence of safety but no data attesting to efficacy, hence Full Spectrum Cannabidiol received a score of 2."

Answered by AI

Are participants being actively sought for this trial?

"Per the clinicaltrials.gov portal, this research endeavour is currently recruiting individuals for participation. It was initially published on April 11th 2023 and most recently revised on April 20th of that same year."

Answered by AI

What goals are this medical experiment striving to achieve?

"The 12-week clinical trial seeks to measure the impact of treatment on Cognition. Secondary goals include assessing changes in Circulating Cytokine Proteins, Depression (as measured by BDI-II), and Quality of Life (measured using SF36)."

Answered by AI

Is it possible for me to join the trial as a subject?

"This clinical trial seeks 120 candidates with traumatic brain injury to participate and meet the age criterion of 18-60 years."

Answered by AI

How many participants is this research endeavor currently accommodating?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this research is still recruiting participants. Initially posted on April 11th 2023, it has since been updated as recently as April 20th and seeks to enrol 120 patients at one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05632627.

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