Phase 2 Multicenter Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of Inhaled Cannabis in Veterans for Treatment of Posttraumatic Stress Disorder (PTSD)
Several preliminary studies suggest that cannabis may treat PTSD symptoms. Building off of our previous MJP1 study, this current study aims to re-examine use of inhaled cannabis for treatment of PTSD using a larger sample size, a parallel design, and methods to mitigate placebo response. This Phase 2 multicenter randomized placebo-controlled, double-blind study will assess the safety and efficacy of inhaled cannabis (high THC) versus placebo to manage PTSD symptoms and pain among approximately 360 veterans in an outpatient setting. The study will be conducted in Michigan and three other sites in the U.S..
- Current Status: Planning
- Redacted MJP2 Study Protocol (Original Protocol: V2 26FEB2021)
- Study Timeline
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FDA Grants In-Person Type A Meeting Request to Discuss Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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MAPS Requests FDA for a Type A Meeting to Discuss Clinical Hold for the Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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Q4 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) #2
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FDA Provides Additional Guidance for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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FDA Continues Clinical Hold for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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MAPS Submits Revised Protocol for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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October 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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Response from FDA Regarding Request to Lift Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) Continued Partial Clinical Hold Response
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Statement on Clinical Treatment Practice using Cannabis to Treat Patients with Symptoms of Posttraumatic Stress Disorder (PTSD)
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July 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) Regulatory Correspondences with FDA
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April 2022 Progress Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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January 2022 Quarterly Performance Report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)