Headings
PROTOCOL MJP-1 IND #110513Amendment 6 Version 1: March 16, 2017Protocol Objectives 12Protocol Design 14Methods 18Investigational Product 39Risks of Participation 43Adverse Events 529.0 Collection of Concomitant Medications and Therapies 5611.0 Study Monitoring, Auditing and Documentation 59Informed Consent 6114.0 Record Retention 64IntroductionProtocol PurposeSupporting InformationMarijuana as a Treatment for PTSD SymptomsRationale for Concentration SelectionProtocol ObjectivesPrimary ObjectiveSecondary ObjectivesSafety ObjectivesProcess ObjectivesProtocol DesignPlanned Duration of StudyRandomization and Participant NumberingRecruitment and Participant PopulationParticipant Inclusion CriteriaParticipant Exclusion CriteriaObserver Inclusion CriteriaObserver Exclusion CriteriaMethodsSafety Measures5.1.3 Process MeasuresStudy Procedures and Visit DescriptionsScreen 1Screen 2EnrollmentIntroductory Sessions in Stage 1 (Visit 1 and Visit 2) and Stage 2 (Visit 8 and Visit 9)Daily Contact after Introductory SessionsSelf Administration During Stage 1 and Stage 2Weekly Evaluations During Stage 1 (Visit 3 and Visit 4) and Stage 2 (Visit 10 and Visit 11)Primary and Secondary Endpoint Evaluations in Stage 1 (Visit 5) and Stage 2 (Visit 12)Two Weeks of Abstinence from Marijuana Self-Administration during Cessation 1 (Visit 6) and Cessation 2 (Visit 13)Re-Baseline Evaluation at End of Cessation 1 (Visit 7) and Cessation 2 (Visit 14)Stage 3Long-term Follow-upRemoval of Enrolled Participants from the StudyPremature Discontinuation of the StudyInvestigational ProductSubstance Concentrations, Packaging and LabelingDosesTable 4: Participant Distribution by Concentration and StagePackagingLabelingFigure 2: Drug Package LabelsSubstance Storage and HandlingSubstance StabilityRisks of ParticipationRisks of Self-administering MarijuanaRisk MitigationMedical EmergenciesAdverse EventsSpontaneously Reported ReactionsSerious Adverse EventsAdverse Event CollectionAdverse Event Reporting9.0 Collection of Concomitant Medications and TherapiesLaboratory AssessmentsBlood Cannabinoid AnalysisResearch Lab Biomarker Analysis11.0 Study Monitoring, Auditing and Documentation12.0 Data Analysis12.1 Statistical PowerInformed ConsentConfidentialityCosts to Participants and CompensationTable 7: Compensation by Study StageTreatment and Compensation for Study Related Injury14.0 Record Retention15.0 Publication Policy16.0 References