Inhaled Cannabis for PTSD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Multidisciplinary Association for Psychedelic Studies

Must not be taking: Antiarrhythmics, Opiates, Methamphetamine, others

Disqualifiers: Pregnancy, Major depressive disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether inhaled cannabis can ease symptoms of PTSD, a mental health condition triggered by a traumatic event, in veterans. Participants will receive either high THC cannabis, which contains a higher concentration of the psychoactive compound THC, or a placebo to determine which is more effective at reducing PTSD symptoms. Veterans who have had PTSD for at least six months and have previously tried inhaling cannabis might be a good fit for this trial. The study aims to gather evidence on the real-world use of cannabis for PTSD, as current data remains limited. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering veterans a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial requires that you be stable on any pre-study medications before starting. You should inform your current doctor about your participation and report any changes in your medication during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inhaled cannabis is generally safe and well-tolerated for people with PTSD. Studies indicate it can improve sleep, boost mood, and reduce PTSD symptoms. In one study, 77.2% of patients experienced an improvement in their PTSD symptoms with cannabis use.

Some side effects should be considered. Users might develop a tolerance, requiring more over time to achieve the same effects. Another study noted some negative effects, though details were not provided. Overall, many people with PTSD have used cannabis and reported benefits, though individual experiences can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike traditional PTSD treatments that often rely on therapy or medications like SSRIs and SNRIs, high THC cannabis offers a unique approach. This treatment is inhaled, allowing for rapid absorption and potentially faster relief of PTSD symptoms. Researchers are particularly interested in how the active ingredient, THC, interacts with the brain's endocannabinoid system, which could offer a new pathway for managing stress and anxiety. Additionally, the use of cannabis could provide an alternative for those who haven't found success with or have had adverse effects from conventional medications.

What evidence suggests that inhaled cannabis might be an effective treatment for PTSD?

Research has shown that cannabis can help reduce symptoms of PTSD. In one review, 77.2% of patients reported fewer symptoms when using cannabis. Another study found that cannabis with high THC levels improved sleep quality for people with PTSD. Evidence also indicates that cannabis can help reduce nightmares, which are common for those with PTSD. In this trial, participants will receive either high THC cannabis or placebo cannabis to evaluate the effectiveness of high THC cannabis in managing PTSD symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for U.S. veterans with PTSD who are interested in exploring the effects of high THC cannabis as a treatment. Participants should not be currently using cannabis or have conditions that might affect their response to the treatment.

Inclusion Criteria

Have previously inhaled cannabis

Meet DSM-5 criteria for PTSD with symptoms (as assessed by the MINI)

Agree to keep all cannabis provided by site staff securely stored and not share/distribute to others

Exclusion Criteria

I have or had dissociative identity disorder, or a family history of psychosis or bipolar type 1.

Are pregnant, nursing, or not practicing effective birth control

Are at high risk of suicide attempt or present serious risk to others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inhaled high THC-containing cannabis or placebo for management of PTSD symptoms

5 weeks

Intro 1 (Day 1), End of Treatment (Day 35)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High THC Cannabis
• Placebo cannabis

Trial Overview The study compares inhaled high THC cannabis against placebo to see if it can help manage PTSD symptoms. It's designed to minimize subjective bias and will use a larger group of participants than previous studies.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Multidisciplinary Association for Psychedelic Studies

Lead Sponsor

Trials

40

Recruited

1,200+

Changemark Research + Evaluation Ltd.

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8222769/

Cannabis in the management of PTSD: a systematic review 77.2% of the patients, had a reduction in PTSD symptoms with the cannabis use (P = 0.0031); whereas 10.5% had not changes in PTSD symptoms. Elms 2019, PCL-5 ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/cooccurring/marijuana_ptsd_vets.asp

Cannabis Use and PTSD Among Veterans Results showed a significant reduction in PTSD symptoms in the THC+CBD group only; however, because there was no placebo group in this phase, it is not possible ...

3. journal-veterans-studies.org journal-veterans-studies.org/articles/10.21061/jvs.v11i1.582

Cannabis Use Characteristics and PTSD-Related ... Multiple studies have reported that cannabis and nabilone, a synthetic form of THC, can improve sleep quality among those with PTSD (Fraser, 2009; Jetly et al., ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0165032720306364

Short and Long-Term Effects of Cannabis on Symptoms ... Findings suggest that THC-dominant, CBD-dominant, and balanced THC:CBD cannabis preparations were associated with short-term reductions in PTSD ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397040/

Cannabis: A potential efficacious intervention for PTSD or ... In this regard, in a small study (n = 10), 5 mg of THC twice a day as an add-on treatment enhanced sleep quality and reduced the frequency of night-mares, PTSD ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02517424

Evaluating Safety and Efficacy of Cannabis in Participants ... The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress ...

7. karger.com karger.com/mca/article/7/1/149/912500/Controlled-Inhalation-of-Tetrahydrocannabinol

Controlled Inhalation of Tetrahydrocannabinol ... The treatment was safe and well tolerated and characterized by marked effects on quality of sleep, general mood, and severity of PTSD-associated ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/14737175.2022.2155139

analysis from the UK Medical Cannabis Registry Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events ...