Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
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|ClinicalTrials.gov Identifier: NCT02759185|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Drug: High THC Marijuana Drug: High CBD Marijuana Drug: High THC/high CBD marijuana Drug: Placebo marijuana||Phase 2|
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Posttraumatic Stress Disorder (PTSD), characterized by an inability to recover from a stress reaction to a traumatic event, is a widely prevalent disorder within the U.S. and across the world. Currently, several psychotherapies are empirically-supported for the treatment of PTSD. However, because of treatment refusal due to treatment type, non-response, and dropout, many individuals continue to experience severe symptoms and meet criteria for PTSD following treatment.
Emerging observational and early clinical evidence suggest that cannabis (marijuana) may have the potential to reduce or ameliorate a number of symptoms experienced by those with PTSD, including sleep difficulty and anxiety. Indeed, some evidence has suggested that delta-9-tetrahydrocannabinol (THC) may serve to reduce nightmares among those with PTSD, while other studies have shown anxiolytic effects of cannabidiol (CBD). However, there have been no randomized controlled trials of cannabis, in any form, for PTSD.
The present triple-blind, randomized, placebo-controlled crossover trial aims to examine the safety and efficacy of four types of cannabis (i.e., high THC, low CBD; high CBD, low THC; equal ratio THC/CBD; and placebo) among 76 military veterans with PTSD of at least six months' duration. Participants will be recruited from one study site, the Scottsdale Research Institute (Phoenix, AZ).
After giving written informed consent, participants will undergo screening for initial eligibility. Potential participants will be required to stop using non-study medical cannabis for two weeks during screening, and for the duration of the study if enrolled. After the two-week washout, a blinded independent rater will administer the Clinician-Administered PTSD Scale (CAPS-5) to assess presence and severity of PTSD symptoms. Self-report measures will also be completed. Eligible participants will then be enrolled and randomized. In the active portion of the study, participants will receive two of four different types of cannabis during two stages (Stage 1 and Stage 2), each lasting three weeks, with crossover and re-randomization at Stage 2. Prior to each stage, participants will complete two introductory sessions where they will be trained on cannabis self-administration. During each stage, participants will be provided 1.8 grams of cannabis daily to smoke ad libitum. Each stage will be followed by a two-week cessation. To reduce the risk of diversion, after the second cessation period, participants will have the option to complete a third stage of the study where they can request the remaining unused cannabis from either Stage 1 or 2.
Study outcomes will be assessed objectively, behaviorally, via self-report, and by a third-party rater. Specifically, blood and urine will be collected to confirm cannabis use status throughout the study, participants will be required to video record self-administration of cannabis, and any unused cannabis from each weekly allotment will be returned to the investigator or designee to be weighed and accounted for prior to dispensing of the next weekly supply. Sleep will be measured via self-report and tracked with actigraphy, clinical interviews will be conducted by blinded independent raters will provide an independent rating of participant behavior.
Participant suicidal ideation will be assessed weekly with the C-SSRS, and daily if results indicate development of suicidal ideation. Weekly evaluations will include measures of symptoms of PTSD, depression, anxiety, sleep quality, general functioning, and responses to cannabis. During each evaluation, actigraph data will also be downloaded and a urine-dip EtG test will be performed. Analysis of blood/urine cannabinoids will be conducted after cessation periods, in addition to weekly urine drug screening for substances other than cannabis. At Baseline and end of Stage 1, Cessation 1 and end of Stage 2, additional blood samples will be collected for analysis of inflammation markers. At the end of Stage 1 and 2, endpoint measures will be administered; an independent rater will evaluate symptoms of PTSD on the CAPS-5 via telemedicine, and self-reported symptoms of anxiety, depression, withdrawal, sleep quality, and psychosocial functioning will be assessed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Posttraumatic Stress Disorder (PTSD)|
|Actual Study Start Date :||January 2, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: High THC marijuana
Provided with up to 1.8 g of marijuana with more tetrahydrocannabinol than cannabidiol
Drug: High THC Marijuana
Three weeks of smoking marijuana containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
Experimental: High CBD marijuana
Provided with up to 1.8 g of marijuana per day of marijuana with more cannabidiol than tetrahydrocannabinol
Drug: High CBD Marijuana
Three weeks of smoking marijuana containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
Experimental: High THC/high CBD marijuana
Provided with up to 1.8 g per day of marijuana with an approximately equal amount of tetrahydrocannabinol and cannabidiol
Drug: High THC/high CBD marijuana
Three weeks of smoking marijuana containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day.
Placebo Comparator: Placebo marijuana
Provided with 1.8 per day of marijuana with very low levels of tetrahydrocannabinol and cannabidiol
Drug: Placebo marijuana
Three weeks of smoking marijuana with low levels of THC and CBD, with smoking limited to no more than 1.8 per day.
Other Name: cannabis
- Change in CAPS Global Severity Score from baseline to primary endpoint [ Time Frame: Baseline, 3 weeks after randomization ]Clinician-Administered PTSD Scale, a measure of PTSD symptom severity
- Change in CAPS Global Severity Score from baseline to secondary endpoint [ Time Frame: Baseline and eight weeks after study randomization ]Clinician-Administered PTSD Scale, a measure of PTSD symptom severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759185
|Contact: study firstname.lastname@example.org|
|United States, Arizona|
|Scottsdale Research Institute||Recruiting|
|Phoenix, Arizona, United States, 85027|
|Principal Investigator: S Sisley, MD|