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THC:CBD 1:10 for Post-Traumatic Stress Disorder (CAPER Trial)

Phase 1

Waitlist Available

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

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

Must have

Between ages 18-60

Not currently receiving any psychotherapy for PTSD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 9 months

Awards & highlights

CAPER Trial Summary

This trial aims to recruit veterans with PTSD who currently use very little cannabis but are interested in using it as a treatment for their mental health symptoms. The goal is to gather information that could help develop new

Who is the study for?

This trial is for veterans with PTSD who use little to no cannabis currently but are open to trying it for anxiety, depression, PTSD, or suicidal thoughts. Specific eligibility criteria were not provided.Check my eligibility

What is being tested?

The study tests different ratios of THC and CBD (1:10, 1:1), CBD alone, THC alone, and a placebo in managing PTSD symptoms in veterans. The goal is to find out if these treatments can help improve mental health.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from THC/CBD may include dizziness, dry mouth, altered senses/perception, mood changes; CBD might cause tiredness or changes in appetite.

CAPER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 60 years old.

Select...

I am not currently in psychotherapy for PTSD.

CAPER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Treatment Response

Secondary outcome measures

Behavioral measures

Blood

Blood pressure

+15 more

CAPER Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: THC:CBD 1:10Experimental Treatment1 Intervention

In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs using a vaporizer containing THC (2.5mg), CBD (2.5mg,25mg) or PBO (0mg THC/CBD). Drug is administered immediately prior to exposure therapy sessions 3-6. 75 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.

Group II: THC:CBD 1:1Experimental Treatment1 Intervention

Group III: Delta-9-tetrahydrocannabinol (THC) onlyExperimental Treatment1 Intervention

Group IV: Cannabidiol (CBD) onlyExperimental Treatment1 Intervention

Group V: Placebo (PBO) onlyPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor

307 Previous Clinical Trials

108,123 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this research investigation?

"For individuals to be eligible for this research, they must have a diagnosis of post-traumatic stress disorder (PTSD) and fall within the age range of 18 to 60. This clinical study aims to recruit a total of 350 participants."

Answered by AI

Are there any available slots for patients to participate in this research study?

"Based on the information provided by clinicaltrials.gov, this particular trial is not currently accepting new patients. The trial was first posted on February 1st, 2024 and last updated on January 11th, 2024. However, it's important to note that there are currently 407 other trials actively recruiting participants at this time."

Answered by AI

Has the Food and Drug Administration (FDA) given their approval for a balanced ratio of THC to CBD at 1:1?

"Based on the classification of this trial as Phase 1, our team at Power assigns a safety rating of 1 to THC:CBD in a 1:1 ratio. This indicates that there is limited available data regarding both safety and efficacy."

Answered by AI

Do participants who are above the age of 70 qualify for enrollment in this clinical trial?

"Prospective participants who are between 18 and 60 years old meet the eligibility requirements for this trial. It is noteworthy that there are 36 clinical trials targeting individuals under the age of 18, as well as an additional 324 trials focusing on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery

Christine Rabinak, PhD 2024. "Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222268.

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