Project Grant R44DA062420

A COMPREHENSIVE DIGITAL INTERVENTION TO REDUCE HEAVY CANNABIS USE - PROJECT ABSTRACT THIS SBIR PHASE II APPLICATION, TITLED "A COMPREHENSIVE DIGITAL INTERVENTION TO REDUCE HEAVY CANNABIS USE," WILL DEVELOP AND EVALUATE THE FIRST PRESCRIPTION DIGITAL THERAPEUTIC FOR ADULTS WITH CANNABIS USE DISORDER (CUD) WHILE SIMULTANEOUSLY DELIVERING A CONSUMER-FACING SELF-MANAGEMENT WELLNESS VERSION. HEAVY CANNABIS USE IS RISING SHARPLY, WITH 20.1 MILLION AMERICANS MEETING CRITERIA FOR CUD EACH YEAR AND FEWER THAN 10% ENGAGING IN FORMAL TREATMENT. DAILY OR NEAR-DAILY USE HAS SURPASSED DAILY ALCOHOL USE AND IS ESPECIALLY PREVALENT AMONG EMERGING ADULTS, WHERE RATES EXCEED 15%. DESPITE THESE TRENDS, NO RIGOROUSLY TESTED CONSUMER APP OR FDA-CLEARED DIGITAL THERAPEUTIC IS AVAILABLE TO ADDRESS CUD, LEAVING A SUBSTANTIAL GAP BETWEEN NEED AND CARE. TO ADDRESS THIS GAP, WE WILL BUILD ON TWO FOUNDATIONS: (1) THE CLEAR30 CONSUMER PLATFORM, WHICH HAS DEMONSTRATED LARGE-SCALE UPTAKE AND MEASURABLE REDUCTIONS IN CANNABIS USE, AND (2) OUR PHASE I SBIR WORK CREATING EVIDENCE-BASED MULTIMEDIA CONTENT FOR YOUNG PEOPLE. THESE PROVIDE BOTH A PROVEN DELIVERY VEHICLE AND A TESTED FRAMEWORK. USING THESE ASSETS, WE WILL CREATE CLEAR90 RX, A PRESCRIPTION DIGITAL THERAPEUTIC THAT MEETS FDA SOFTWARE-AS-A-MEDICAL-DEVICE REQUIREMENTS. CLEAR90 RX WILL INTEGRATE BEHAVIORAL SKILLS, RELAPSE-PREVENTION MODULES, AND ADAPTIVE PERSONALIZATION INFORMED BY CANNABIS USE PATTERNS WITHIN AN ENGAGING MOBILE APPLICATION. EFFICACY WILL BE TESTED IN A RANDOMIZED CONTROLLED TRIAL WITH 460 ADULTS AGED 18 AND OLDER WITH MODERATE-TO- SEVERE CUD CONDUCTED AT THE RECOVERY RESEARCH INSTITUTE AT MASSACHUSETTS GENERAL HOSPITAL. PARTICIPANTS WILL BE RANDOMIZED TO CLEAR90 RX OR A CANNABIS-TRACKING CONTROL, WITH PRIMARY OUTCOMES OF CUD REMISSION AT 90 DAYS AND REDUCTIONS IN CANNABIS FREQUENCY AND QUANTITY. SECONDARY OUTCOMES WILL INCLUDE IMPROVEMENTS IN MENTAL HEALTH, FUNCTIONING, AND QUALITY OF LIFE. TRIAL RESULTS WILL PROVIDE PIVOTAL EVIDENCE FOR FDA DE NOVO SUBMISSION, WITH THE EXPLICIT DELIVERABLE OF A STAND-ALONE FDA-CLEARED THERAPEUTIC. COMMERCIALIZATION ACTIVITIES WILL PROCEED IN PARALLEL, LEVERAGING EARLY PILOTS WITH NEW YORK STATE AND THE CITY OF DETROIT TO UNDERSTAND ENGAGEMENT WITH STATE AND CITY PAYORS. WE WILL ALSO DEVELOP PARTNERSHIPS WITH HEALTH SYSTEMS, PRIVATE PAYORS, AND HIGHER EDUCATION INSTITUTIONS AS WELL AS PRIVATE PAYORS IN PARALLEL TO THE CLINICAL TRIAL. THE OUTPUTS OF THIS PROJECT WILL BE A PRESCRIPTION THERAPEUTIC TO TREAT CUD AND A CONSUMER WELLNESS VERSION, CLEAR90 CONSUMER WELLNESS, MODELED AFTER BOTH CLEAR90 RX AND OUR EXISTING CLEAR30 WELLNESS CANNABIS REDUCTION MOBILE APP. TOGETHER, THESE PRODUCTS WILL EXPAND ACCESS TO EVIDENCE-BASED INTERVENTIONS FOR CUD, REDUCE CANNABIS-RELATED HARMS, AND CREATE A SUSTAINABLE PATH TO LARGE-SCALE PUBLIC HEALTH IMPACT.