Advancing Cannabis Intervention Research to Address PTSD in Veterans

Multidisciplinary Association for Psychedelic Studies (MAPS) 

Clinical Trial

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit organization at the vanguard of the psychedelic movement. Founded in 1986, MAPS works to develop the medical, legal, and cultural contexts for people to safely benefit from psychedelics and cannabis. 

Building on decades of research and advocacy, MAPS partners with governments, research institutions, and clinical teams around the world to advance evidence-based treatments for mental health conditions such as PTSD, depression, anxiety, and substance use disorders.

Challenge

MAPS launched MJP2, a Phase II multicentre randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of inhaled cannabis for the treatment of Posttraumatic Stress Disorder (PTSD) in veterans. 

Funded through a $12.9 million grant from the Michigan Veteran Marijuana Research Grant Program, this landmark study is one of the largest and most ambitious cannabis trials in the world. MAPS’ successful navigation of a dispute resolution process with the U.S. Food and Drug Administration (FDA) cleared the way for the protocol to mirror real-world cannabis consumption. 

Conducting a multi-site, controlled-substance trial with veterans required navigating a highly complex regulatory landscape, multi-jurisdictional ethics approvals, and stringent pharmacovigilance standards. MAPS needed a contract research organization (CRO) with: 

  • Deep expertise in psychedelic and cannabis research 

  • Experience managing controlled-substance regulations 

  • Trauma-informed clinical operations and values aligned with healing, justice, and evidence-based care. 

Solution

Changemark is providing end-to-end clinical trial services for MAPS, integrating scientific rigor, operational excellence, and compassionate care in every phase of the study. 

Through a multidisciplinary team of experts in clinical research, Changemark supports MAPS in delivering one of the largest clinical trials of inhaled cannabis for PTSD to date, with precision, compliance, continuity, and aiming for maximum impact. 

The project includes:

Operational Services

  • Conduct the pre-implementation phase preparation, vendor, and site management

  • Preparation and maintenance of IRB submissions, including  ethics approvals, and safety reports 

  • Integration of multi-site governance systems to ensure operational consistency across all participating jurisdictions 

  • Oversight of monitoring, data management, and pharmacovigilance systems to uphold participant safety and data integrity 

  • Coordination of cross-jurisdictional regulatory compliance, ensuring all study activities meet the highest standards of controlled-substance research 


Data + Quality Oversight

  • Creation of a unified data management and monitoring framework, integrating biostatistics, safety oversight, and medical monitoring 

  • Deployment of a specialized eight-member international team, including experts in regulatory affairs, data management, and medical oversight 

  • Development of SOPs, site tools, and training protocols to maintain study quality and compliance 

  • Continuous data review and progress reporting to support adaptive decision-making and maintain transparency across partners 

  • Biostatistical services and statistical analysis planning 

  • Medical writing including clinical study report, manuscript preparation and report generation. 

Results

MJP2 is actively underway, representing a pivotal moment in the evolution of cannabis research for trauma and mental health. 

Impact Highlights to Date:

  • Phase II trial pre-implementation activities launched successfully across multiple jurisdictions 

  • Regulatory submissions and ethics approvals maintained 

  • Monitoring, safety oversight, and data systems fully operational 

  • Participating site engagement activities underway 

  • Cross-disciplinary research team managing trial coordination, compliance, and analysis 

By embedding scientific integrity into each stage of trial delivery, Changemark is ensuring that MAPS can focus on advancing evidence-based care for veterans while meeting the highest global research standards. 

Interested in Learning More?

Let’s talk about how we can help you design and deliver clinical trials with the highest standards of scientific and ethical integrity. 

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