Cannabis for PTSD in Veterans

(CBH Trial)

Overseen By Leslie Lundahl, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Wayne State University

Disqualifiers: Hypertension, Psychotic disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you test positive for drugs other than cannabis, nicotine, or mild to moderate alcohol use.

What evidence supports the effectiveness of the drug for PTSD in veterans?

Research suggests that cannabidiol (CBD) may help reduce anxiety and improve symptoms in people with PTSD by affecting the endocannabinoid system, which is involved in stress and memory regulation. Studies have shown promising results in both animal models and small human trials, indicating potential benefits for PTSD symptoms like sleep disorders and anxiety. ^{1 2 3 4 5}

Is cannabis safe for treating PTSD in veterans?

Cannabidiol (CBD) is generally considered safe, but some studies report side effects like dry mouth, sleepiness, and fatigue. When combined with tetrahydrocannabinol (THC), it may cause additional effects like nausea. More research is needed to fully understand its safety, especially regarding reproductive and developmental health. ^{1 4 6 7 8}

How is the drug Cannabidiol (CBD) unique in treating PTSD in veterans?

Cannabidiol (CBD) is unique in treating PTSD because it targets the endocannabinoid system, which plays a role in regulating fear and stress responses, unlike traditional treatments that may not address these pathways. CBD is a non-psychotomimetic compound, meaning it doesn't cause the 'high' associated with cannabis, and it has shown promise in modulating fear memory and improving symptoms like sleep disturbances and anxiety. ^{2 3 4 6 9}

What is the purpose of this trial?

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Eligibility Criteria

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.

Inclusion Criteria

Report using cannabis (no more than 2x in last month and no more than 100 lifetime use episodes)

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

Able to provide informed consent

Exclusion Criteria

Systolic/diastolic BP >140/90 mmHg

At immediate high risk for suicide based on the C-SSRS

Current substance use disorder other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized into one of four groups and undergo a 12-week treatment phase, vaporizing their assigned cannabis dose daily.

12 weeks

12 visits (weekly, in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals.

9 months

4 visits (1 week, 3, 6, and 9 months post-treatment)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Cannabidiol
• Tetrahydrocannabinol

Trial Overview 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.

Participant Groups

Group I: THC Group Experimental Treatment 1 Intervention

Cannabis with 2.5 mg THC; up to a maximum of 5 doses/day (max dose = 12.5 mg THC)

Group II: THC & CBD Group Experimental Treatment 2 Interventions

Cannabis with 2.5 mg THC and 2.5 mg CBD; up to a maximum of 5 doses/day (max doses = 12.5 mg THC and 12.5 mg CBD)

Group III: CBD Group Experimental Treatment 1 Intervention

Cannabis with 2.5 mg CBD; up to a maximum of 5 doses/day (max dose = 12.5 mg CBD)

Group IV: Placebo Group Active Control 1 Intervention

Cannabis with \<1mg THC and \<1mg CBD; up to a maximum of 5 doses/day (max dose = \<5 mg THC and \<5 mg CBD)

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Findings from Research

In a study of 33 PTSD patients, administering 300 mg of cannabidiol (CBD) before recalling a nonsexual traumatic event significantly reduced anxiety and cognitive impairment compared to a placebo.

However, CBD did not show a significant effect on anxiety or cognitive impairment in patients recalling sexual trauma, suggesting that the efficacy of CBD may depend on the nature of the traumatic event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anxiolytic effect of cannabidiol depends on the nature of the trauma when patients with post-traumatic stress disorder recall their trigger event. Bolsoni, LM., Crippa, JAS., Hallak, JEC., et al.[2022]

A systematic review of 10 studies suggests that medicinal cannabinoids like CBD, Δ9-THC, and nabilone may improve overall PTSD symptoms and specific issues such as sleep disorders and arousal disturbances, potentially enhancing quality of life.

While the results are promising for using cannabinoids as a treatment for PTSD, more research is necessary to fully understand the safety and long-term efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocannabinoid System as Therapeutic Target of PTSD: A Systematic Review. Steardo, L., Carbone, EA., Menculini, G., et al.[2021]

In a mouse model of PTSD, cannabidiol (CBD) significantly reduced PTSD-like symptoms by affecting trauma-related fear memory and anxiety behaviors, showing its potential as a treatment option.

Unlike the antidepressant sertraline, which was only effective when given before exposure to fear, CBD was effective regardless of when it was administered, indicating a broader mechanism of action in fear memory processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between cannabidiol and sertraline for the modulation of post-traumatic stress disorder-like behaviors and fear memory in mice. Han, X., Song, X., Song, D., et al.[2022]

In a study of 11 adults with PTSD, 91% experienced a reduction in symptoms after 8 weeks of oral CBD treatment, with an average decrease in PTSD Checklist scores of 28%.

CBD was well tolerated by patients, with no discontinuations due to side effects, suggesting it may be a safe adjunct treatment for PTSD alongside standard psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. Elms, L., Shannon, S., Hughes, S., et al.[2020]

In a study involving 27 healthy volunteers, a single clinically anxiolytic dose of 300 mg of CBD did not significantly affect the sleep-wake cycle, indicating it does not interfere with normal sleep architecture.

Unlike traditional anxiolytic medications, CBD appears to maintain the natural sleep patterns of individuals, suggesting it may be a safer alternative for anxiety management without disrupting sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. Linares, IMP., Guimaraes, FS., Eckeli, A., et al.[2020]

This study is the first placebo-controlled clinical trial examining the efficacy of cannabidiol (CBD) for treating PTSD, involving 150 participants over an 8-week period.

The trial compares the effects of two types of CBD (Isolate and Broad Spectrum) on PTSD symptoms, with outcomes measured using the PTSD Checklist for DSM-5, aiming to assess both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial. Telch, MJ., Fischer, CM., Zaizar, ED., et al.[2023]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a study of 198 participants with anxiety disorders, treatment with various cannabis formulations significantly improved quality of life outcomes, including reductions in anxiety, depression, and fatigue, as well as enhanced social functioning.

Common adverse events reported included dry mouth, somnolence, and fatigue, with gastrointestinal issues more prevalent in formulations containing THC, indicating a need for careful consideration of cannabis formulation in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study. Stack, SK., Wheate, NJ., Moloney, NC., et al.[2023]

Cannabidiol (CBD) shows promise as a therapeutic option for treating COVID-19-related anxiety and post-traumatic stress symptoms, supported by small randomized controlled trials that demonstrate its anxiolytic effects in various populations.

Pre-clinical studies indicate that CBD interacts with specific receptors in the brain, such as cannabinoid receptors and serotonin receptors, which may help reduce anxiety and improve sleep quality, making it a potential candidate for further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could Cannabidiol Be a Treatment for Coronavirus Disease-19-Related Anxiety Disorders? O'Sullivan, SE., Stevenson, CW., Laviolette, SR.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

The anxiolytic effect of cannabidiol depends on the nature of the trauma when patients with post-traumatic stress disorder recall their trigger event. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Endocannabinoid System as Therapeutic Target of PTSD: A Systematic Review. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison between cannabidiol and sertraline for the modulation of post-traumatic stress disorder-like behaviors and fear memory in mice. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Could Cannabidiol Be a Treatment for Coronavirus Disease-19-Related Anxiety Disorders? [2022]