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 320 Veterans in an outpatient setting. The study will be conducted in Michigan and three other sites in the U.S..
- Current Status: Planning
- Sponsor: MAPS
- Funded by: Michigan Veteran Marijuana Research Grant Program; Press Release
- Redacted MJP2 Study Protocol
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MAPS Partners with Changemark to Advance Cannabis PTSD Research for Veterans
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MAPS Submits Cannabis Data Safety Update Report 2024 and Protocol Amendment to FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)
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MAPS Successfully Clears Path for Cannabis Research through FDA Formal Dispute
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MAPS cleared to proceed by FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)
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MAPS submits sixth Clinical Hold Response to FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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MAPS achieves agreement on three key points despite “Appeal Denied” letter received from FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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MAPS Submits Formal Dispute Resolution Request Against FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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MAPS Submits Cannabis Data Safety Update Report 2023 to FDA on Phase 2 Study of Smoked 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 Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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FDA Division of Pulmonology, Allergy, and Critical Care Provides Additional Guidance on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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FDA Sends the Official Minutes of Type A Meeting for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)
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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)

