Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic Your access to this site has been limited by the site owner If you think you have been blocked in error, contact the owner of this site for assistance. If you are a WordPress user with Two recent studies point to the way that cannabinoids may help treat PTSD. One shows how cannabis can reduce activity in the amygdala – a part of the brain associated with fear responses to threats. Another suggests the plant’s role in extinguishing traumatic memories.
Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder
The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic stress disorder using a rigorous double-blind randomized clinical trial methodology. Participants (n=150) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of 3 treatment arms: (a) CBD -Isolate; (b) CBD-Broad Spectrum; (c) Placebo oil.
We predict that patients receiving CBD isolate or CBD Broad Spectrum will show significantly greater improvements in PTSD symptoms and functional impairment at the posttreatment, one month, and three month follow-up assessments relative to patients receiving placebo oil. Additionally, we expect that patients receiving CBD Broad Spectrum will show significantly greater improvements relative to patients receiving CBD Isolate.
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Drug: CBD Isolate Other: CBD Broad Spectrum Other: Placebo oil||Phase 2|
Background and Significance of the Proposed Project
Over 80% of Americans are exposed to a significant trauma sometime during their lifetime and approximately 7% will meet for a threshold diagnosis of posttraumatic stress disorder. PTSD is the most costly anxiety-related disorder and confers significant interference in work, social functioning, increased risk for other physical and mental health problems, and a four-fold increase in suicide rates compared to the general population.
Over the past two decades, trauma-focused psychotherapies for PTSD have been shown to outperform more traditional supportive psychotherapy or pharmacotherapy and have become the first line treatment for PTSD. Despite these advances, trauma focused treatments such as prolonged exposure therapy (PE) are associated with high rates of treatment refusal, and among those who do enter treatment, approximately 25% drop-out. These data highlight the need to develop PTSD treatment strategies that are both effective and more palatable to patients.
More recently, there’s been considerable excitement in the press over the potential therapeutic use of cannabidiol (CBD) products in the treatment of a variety of physical and mental health problems.( Delta-9-tetrahydrocannabinol (delta-9 THC) is still illegal in most states because of its psychoactive abuse potential. In contrast, cannabidiol (CBD) does not convert to THC in the body and has negligible side effects relative to main stream psychiatric drugs (benzodiazepines and antidepressants) commonly prescribed for the treatment of PTSD. Mounting evidence from studies with rodents suggests that CBD may confer significant promising health-related benefits including anti-inflammatory, pain-relieving, anti-cancer, memory enhancement, and facilitation of fear extinction (see White for a recent review).
The biggest success story for CBD use in humans to date comes from controlled randomized clinical trials demonstrating a 50% or more reduction in previously intractable seizures in children suffering from Dravet syndrome and Lennox-Gastaut syndrome. Moreover, several controlled clinical trials have shown promising findings in reducing psychotic symptoms among patients with schizophrenia and among young adults displaying THC-induced psychosis.
Preliminary Evidence that CBD may offer promise in the treatment of anxiety-related disorders has started to emerge. A small pilot trial with 24 patients presenting with social anxiety disorder found that relative to placebo, a single dose of 100 mg of CBD oil led to lower levels of anxiety, cognitive impairment, and discomfort in their actual speech performance as well as their anxiety before the speech. Unfortunately, human treatment studies for anxiety-related problems is limited almost exclusively to single dose effects on an anxiety challenge task. Studies are clearly needed to assess the effects of multi-dose CBD treatments across the full spectrum of trauma and anxiety-related disorders such as posttraumatic stress disorder.
The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of posttraumatic stress disorder using a rigorous double-blind randomized clinical trial methodology.
Specific aims of the project include:
Compare the efficacy of an 8-week multi-dose regimen of two CBD oil formulations (CBD Isolate (300 mg/day) and CBD Broad Spectrum) relative to placebo oil in reducing clinician and patient-rated PTSD symptoms at the posttreatment and one month follow-up assessments.
We predict that patients receiving CBD oil (CBD isolate or CBD Broad Spectrum) will show significantly greater improvement in PTSD symptoms and functional impairment at post-treatment and one month follow-up relative to patients receiving placebo oil.
We also predict that patients receiving the CBD Broad Spectrum formulation will show significantly greater improvement in PTSD symptoms and functional impairment relative to patients receiving CBD Isolate.
Examine predictors of patients’ clinical response to the various treatment combinations.
We expect that the superiority of CBD relative to placebo will be more pronounced for patients showing more severe PTSD symptoms at baseline and for those showing significant sleeping difficulties.
We expect that CBD-treated patients will show equivalent levels of side effects as those receiving placebo oil.
STUDY METHODS AND PROCEDURES
Participant Recruitment: 150 participants between the ages of 18 and older will be recruited through several outlets including notices posted on campus, announcements on our research laboratory website and national organizations related to PTSD and its treatment.
Participant Screening: Participants will undergo a two-stage screening procedure. Stage 1 will be a brief structured web-based screening interview. Stage 2 will be a telephone-administered structured clinical interview (CAPS-5). Participants meeting the following inclusion and exclusion enrollment criteria will be invited to take part in the study (see below).
NOTE: ALL STUDY PROCEDURES ARE COMPLETED AT PARTICIPANTS’ HOMES. NO VISITS TO OUR RESEARCH LABORATORY ARE REQUIRED.
- Meets for a current DSM-5 diagnosis of PTSD as their “primary” mental disorder
- Age between 18 to 70
- Fluent in English
- Willingness to provide signed informed consent online
- No history of a suicide attempt in the past 6 months
- No history of psychosis with the past 6 months
9. No history of current alcohol or substance use disorder within the past 6 months.
10. No current medical problems that would preclude safe ingestion of CBD oil 11. Willingness to refrain from other forms of Cannabis use during the 8-week treatment phase of the study.
12. Has home access to the internet.
Participant Informed Consent:
All study participants will be consented by the study coordinator or a doctoral student research assistant during the screening visit conducted over the phone. The online informed consent document will provide participants with information regarding the aims of the project, what they will be asked to do, any anticipated risks or benefits associated with participating in the study, as well as a clear statement that their participation is voluntary and that they may discontinue participation at any time.
Study Design Overview: The research plan is to conduct a Phase II double-blind placebo controlled randomized clinical trial comparing the efficacy of two CBD oil (300 mg./day) versus Placebo Oil.
Nightly dosing of a hemp-derived formulation of purified CBD isolate (300 mg), CBD Broad Spectrum (300 mg.) or matching placebo oil daily for 8 weeks. Individual doses of both CBD formulations and placebo oil will be provided in identical individual plastic syringes. All patients, PI, and staff who interact with study participants will be blind to participants’ assigned treatment condition.
Clinical Assessment Schedule:
Week 0 – Pre-Treatment Screening Visit: All enrolled study participants will complete from their home a clinical assessment battery consisting of (a) self-report rating scales over the Internet (see measures); and (b) a structured clinical interview (CAPS-5).
Treatment Visits (Weeks 1 – 8) : During this phase, all study participants will (a) receive via Fed-Ex their weekly allotment of CBD/Placebo oil; (b) complete weekly clinical status assessments via the Internet (see measures).
Posttreatment Assessment Visit (Week 9): All participants will complete an online battery of clinical outcome measures identical to those administered during their pre-treatment visit (see outcome measures).
1-Month Follow-up Assessment Visit (Week 13) – All participants will be re-administered the complete battery of primary and secondary outcome measures (see outcome measures).
Primary Clinical Outcomes: The primary clinical outcomes will be (a) scores on the Clinician Administered PTSD Scale (CAPS-5) and (b) independent evaluator ratings of clinical status using the Clinical Global Improvement Scale administered at each of the three posttreatment assessment periods (Week 9, Week 13).
Secondary Clinical Outcomes: Several additional psychiatric outcomes will be assessed at each of the three follow-up assessment visits. These clinical outcomes and their respective measures appear below. Additional information on these measures is available in the accompanying cited publication for each measure.
- Patient-rated PTSD symptoms using the PCL-5
- Depression – Patient Health Questionnaire (PHQ-9)
- Life Impairment – Sheehan Disability Scale (SDS)
- Quality of Life – World Health Organization (WHOQOL-BREF)
- Substance Use Disorders – NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test (NIDA M-ASSIST)
- Pittsburgh Sleep Quality Index (PSQI)
Data Management Data Management involves development of methods for ensuring that data collection instruments are programmed; data are properly collected; participants are tracked and monitored over the course of the study; data sets are documented and maintained; variables are created and documented; and main analyses are conducted. To enhance quality control, all data for the current study including demographic information, diagnoses, and participant and clinician rated measures will be directly entered into a HIPPA compliant electronic case report form (eCRF) using Qualtrics – a secure cloud-based platform designed exclusively for supporting HIPPA compliant data capture and storage. Qualtrics provides: (a) An intuitive interface for data entry with data validation; (b) Audit trails for tracking data manipulation and export procedures; (c) Procedures for importing data from external sources; (d) Automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R) to facilitate data analysis; (e) automated and secure data back-up and storage to servers housed at the University of Texas Population Research Center (PRC). Dr. Telch in his role as Principal Investigator will serve as the Senior data manager and will meet bi-weekly with the biostatistician and research staff on issues related to data management.
Your access to this site has been limited by the site owner
If you think you have been blocked in error, contact the owner of this site for assistance.
If you are a WordPress user with administrative privileges on this site, please enter your email address in the box below and click “Send”. You will then receive an email that helps you regain access.
Block Technical Data
|Block Reason:||Access from your area has been temporarily limited for security reasons.|
|Time:||Wed, 14 Sep 2022 14:21:45 GMT|
Click here to learn more: Documentation
New Research Reveals Why Cannabis Helps PTSD Sufferers
Amy Rising, an Air Force veteran, smokes medical marijuana. Rising has been working on legislation . [+] for veterans’ freedom to treat PTSD with medical cannabis. (Photo by Kevin Cook for The Washington Post via Getty Images)
The Washington Post via Getty Images
PTSD patients have been saying for years that cannabis helps with their PTSD. This debilitating condition causes chronic problems like nightmares, panic attacks, hypervigilance, detachment from others, overwhelming emotions, and self-destructive behavior. In some cases, these overwhelming symptoms can even lead to suicide. And while research on the topic has been somewhat inconclusive, many PTSD patients continue to report that cannabis does help.
Now, new research suggests the biological mechanisms behind this therapeutic effect.
Two recent studies point to the way that cannabinoids may help treat PTSD. One shows how cannabis can reduce activity in the amygdala – a part of the brain associated with fear responses to threats. Meanwhile, another suggests that the plant’s cannabinoids could play a role in extinguishing traumatic memories. Both effects could be therapeutic for those suffering from PTSD – according to recent studies.
One study, from researchers at Wayne State University in Detroit, MI, looked at how cannabis use impacts the amygdala response of those dealing with trauma related anxiety, such as PTSD. Previous research has shown that cannabis has the potential to reduce anxiety, or even prevent heightened anxiety in threatening situations. But up to this point, no studies had investigated this response in adults dealing with trauma – such as those with PTSD.
The Wayne State University study took on this challenge, and studied the amygdala responses in three groups of participants – healthy controls who had not been exposed to trauma, trauma exposed adults without PTSD and trauma exposed adults with PTSD. Using a randomized, double-blind procedure, the 71 participants were either given a low dose of THC or a placebo. Then they were exposed to threatening stimuli and their amygdala responses were recorded.
Best Travel Insurance Companies
Best Covid-19 Travel Insurance Plans
Those exposed to THC had lowered threat-related amygdala reactivity.
This means that those who took low doses of THC showed measurable signs of reduced fear and anxiety in situations designed to trigger fear. Since these results were found in all three groups, it suggests that even those with PTSD were able to experience less fear with THC in their system.
DENVER, CO – JULY 15: The Colorado Board of Health had a rule making hearing about people with . [+] PTSD qualifying for medical marijuana at the Colorado Department of Public Health and Environment offices in Denver. Christopher Latona, center, and his dad Mike Latona, left, both testified in support of approving medical marijuana for PTSD which Christopher has suffered from since returning from his US. Army service in Afghanistan. They were photographed on Wednesday July 15, 2015. The board voted 6-2 not to approve the change. (Photo by Cyrus McCrimmon/The Denver Post via Getty Images )
Denver Post via Getty Images
The authors conclude that the research suggests “that THC modulates threat-related processing in trauma-exposed individuals with PTSD” and add that the drug “may prove advantageous as a pharmacological approach to treating stress- and trauma-related psychopathology.”
A second study, from researchers at Brazil’s Federal University of Parana, explored another potential way that cannabis could help those with PTSD – extinguishing the intensity associated with memories of their trauma. This mode of treating PTSD was first hypothesized by Yale associate professor of psychiatry R. Andrew Sewell who suggested that cannabis may be able to help PTSD patients “overwrite” traumatic memories with new memories in a process called ‘extinction learning’.
In an interview with East Bay Express, Sewell explained that the extinction learning process usually helps trauma resolve on its own. He gave the example of an Iraq War Veteran who gets PTSD symptoms while driving under bridges – after dodging explosives thrown down from bridges during the war. “Suppose some part of your reptile brain thinks if you walk under a bridge you’re going to die,” Sewell explained “life becomes very hard.”
Army veteran Kevin Grimsinger 42 and other vet’s and supporters from Sensible Colorado submit a . [+] petition to add PTSD to the list of conditions approved for the use of medical marijuana to Mark Salley the communications director for the Colorado Department of Public Health and Environment Wednesday July 7th, 2010. Joe Amon, The Denver Post (Photo By Joe Amon/The Denver Post via Getty Images)
Denver Post via Getty Images
For most who experience traumatic incidents, these fears subside after 6 months or so because of the extinction learning process. New memories of the traumatic trigger form and override the old. Someone with a traumatic experience of explosives being dropped from bridges, may at first feel terrified as they approach any bridge – with traumatic memories flooding their mind. But after months of nothing bad happening around bridges, most will begin to feel bridges are less dangerous, as many memories of driving under bridges safely accumulate. The old memories still linger, but they don’t cause the increase in fear when the trigger (like the bridge) is present. So while most with trauma remember the traumatic incidents, those memories no longer trigger intense fear.
But for those with PTSD, extinction learning doesn’t happen. The trauma attached to the old memories continues to cause problems.
Still, Sewell believed that cannabis could help. Cannabis stimulates CB1 – a receptor in the endocannabinoid system that Sewell says has improved extinction learning in animal studies. Interestingly, those with PTSD show impaired functioning of the endocannabinoid system – which may be why they are unable to go through the normal extinction learning process.
Sewell theorized that cannabis might be able to jump start this process – allowing those with PTSD to access extinction learning like their healthy counterparts, and curing the PTSD by helping them to move on from their trauma. Unfortunately, he was unable to complete his research before he unexpectedly passed away in 2013.
study from Brazil’s Federal University of Parana looks deeper into the question. These researchers conducted a thorough review of the cannabis literature from 1974-2020 looking for evidence from controlled human trials to support or refute the theory that cannabis helps with ‘extinction’ of traumatic memories.
The researchers found that cannabis could help. Low doses of the cannabinoid THC or THC combined with another cannabinoid CBD were both able to enhance the extinction rate for challenging memories – and reduce overall anxiety responses. From their study, it seems that THC drives the extinction rate improvements, while CBD can help alleviate potential side effects from higher doses of THC.
The authors conclude that the current evidence from both healthy humans and PTSD patients suggests that these forms of cannabis “suppress anxiety and aversive memory expression without producing significant adverse effects.”
These studies provide some answers about why cannabis is helping PTSD patients feel better – both immediately and in the long run. Still, future studies may help clarify a range of questions about how and when to use cannabis effectively for PTSD, and whether there are risk factors associated with using the drug for this condition.