Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
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This study was the first randomized placebo-controlled trial of smoked cannabis for posttraumatic stress disorder (PTSD) which explored whether three different concentrations of smoked marijuana could help reduce PTSD symptoms in 76 U.S. veterans with chronic, treatment-resistant PTSD. Participants were U.S. veterans, aged 18 or older with a diagnosis of PTSD that did not improve after trying either medication or psychotherapy.
The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2. The treatments consisted of High THC (approximately 12% THC and < 0.05% CBD), High CBD (11% CBD and 0.50% THC), THC+CBD (approximately 7.9% THC and 8.1% CBD), and placebo (< 0.03% THC and < 0.01% CBD).
All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment. However, no active treatment with cannabis outperformed placebo.
Study Data
Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
- High THC cannabis, Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.
- High CBD cannabis, Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.
- THC/CBD cannabis, Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.
- Placebo cannabis, Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.
Study Timeline
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MAPS Submits Revised Marijuana/PTSD Protocol to FDA
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MAPS Addresses FDA Concerns about Planned Marijuana/PTSD Study
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NIDA Claims to Have Marijuana Required for Marijuana/PTSD Study
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Study MJP1 on clinical hold
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MJP1 clinical hold
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MJP1 clinical hold
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Marijuana for PTSD Protocol Submitted to FDA and NIDA
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Marijuana/PTSD Study Gains Julie Holland, M.D., as Medical Monitor
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MAPS Receives IND # for Marijuana
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MAPS New Marijuana/PTSD Study Design Finalized
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New Marijuana-for-PTSD Protocol Close to Complete

