Cannabis for PTSD in Veterans (CBH Trial)

Phase 1 & 2

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

Meet DSM-5 criteria for PTSD with symptoms of at least 6 months duration

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up biological samples will be collected at a pre-treatment (at the baseline visit); during the 12-week treatment phase (every two weeks during the treatment phase); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months po

Summary

This trial will test if cannabinoids can help veterans with PTSD and thoughts of suicide.

Who is the study for?

This trial is for veterans with PTSD who may also be using cannabis. It's designed to help those struggling with suicidal thoughts. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.

What is being tested?

The study tests the effects of Cannabidiol (CBD) and Tetrahydrocannabinol (THC), components of cannabis, against a placebo to see if they can help treat PTSD in veterans. The participants will be randomly assigned to one of these treatments.

What are the potential side effects?

While not specified here, CBD could cause tiredness, diarrhea, or changes in appetite/weight. THC might lead to increased heart rate, coordination issues, dry mouth or red eyes. Both can affect mood and mental state.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with PTSD and have had symptoms for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 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

Assessing Suicidality over time using the C-SSRS assessment.

Assessing Suicidality throughout the study using the SBQ-R assessment.

Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.

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Secondary study objectives

Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD.

Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires.

Assess demographics using a self-report assessment

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