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Cannabis Compounds for PTSD (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

Must not have

Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD

Traumatic brain injury (TBI) with current cognitive impairment related to TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 9 months

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 60 years old.

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I am not currently in psychotherapy for PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My current mental health condition is more prominent than PTSD.

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I have cognitive issues due to a past brain injury.

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I have a current diagnosis of a blood, hormone, brain, heart, lung, immune system, or nerve disease.

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I am not taking daily medication that severely interacts with cannabis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Response

Secondary study objectives

Blood pressure

Brain measures

Brief Pain Inventory (BPI)

+14 more

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 / 6Eligibility criteria met