UG3AG094957

PSYCHEDELICS FOR OLDER ADULTS WITH CHRONIC PAIN - SUMMARY ABSTRACT CHRONIC PAIN IS HIGHLY PREVALENT (38%) CONDITION IN OLDER ADULTS AND IMPACTS QUALITY OF LIFE WITH INCREASED DEPRESSION, ANXIETY, EXISTENTIAL DISTRESS, AND SOCIAL ISOLATION, AND ASSOCIATED WITH AN INCREASED RISK IN OVERALL MORBIDITY AND MORTALITY. EXISTING PHARMACOLOGIC THERAPIES FOR OLDER ADULTS HAVE LIMITED EFFICACY AND SIGNIFICANT SIDE EFFECTS. PSYCHEDELIC ASSISTED THERAPY (PAT) HAS DEMONSTRATED PRELIMINARY SAFETY AND EFFICACY FOR IMPROVING MENTAL HEALTH (E.G., DEPRESSION, EXISTENTIAL DISTRESS), ADDICTION, AND CHRONIC PAIN IN NON-ELDERLY ADULTS. HOWEVER, PUBLISHED RESEARCH TO DATE HAS NOT INCLUDED OLDER ADULTS WHO HAVE BEEN SEVERELY UNDER- REPRESENTED IN STUDIES TO DATE. THIS LACK OF SAFETY AND EFFICACY DATA IN OLDER ADULTS IS A CRITICAL PUBLIC HEALTH NEED. TO RESPOND TO THIS RESEARCH GAP, WE PROPOSE THE INSPIRE NETWORK (INNOVATION IN SCIENCE OF PSYCHEDELICS WITH INCLUSIVE RESEARCH IN ELDERS), A GEOGRAPHICALLY DIVERSE, TRANSDISCIPLINARY CONSORTIUM COMPRISED OF SITES WITH ESTABLISHED PSYCHEDELIC RESEARCH PROGRAMS AND EXPERTISE IN GERIATRICS, CHRONIC PAIN, PSYCHIATRY, PALLIATIVE CARE, AND MULTI-SITE CLINICAL TRIALS. INITIAL RESEARCH WILL FOCUS ON PSILOCYBIN, DUE TO ITS FAVORABLE SAFETY PROFILE AND EVIDENCE FOR PRELIMINARY EFFICACY IN RELATED PSYCHIATRIC CONDITIONS (E.G. DEPRESSION, ANXIETY, EXISTENTIAL DISTRESS), AND ON LYSERGIC ACID DIETHYLAMIDE (LSD), DUE TO EARLY EVIDENCE SUGGESTING SAFETY AND EFFICACY IN TREATING PAIN, AS WELL AS PSYCHIATRIC AND EXISTENTIAL DISTRESS IN ADVANCED CANCER PAIN SYNDROMES. IN THE UG3 PHASE, WE WILL EVALUATE THE PHARMACOKINETIC (PK) AND PHARMACODYNAMIC (PD) CHARACTERISTICS OF THESE TWO DRUGS IN HEALTHY OLDER ADULTS, WITH RESULTS INFORMING SELECTION OF DRUG(S) AND DOSES FOR THE UH3 PHASE. IN THE UH3 PHASE, WE WILL CONDUCT TWO RANDOMIZED TRIALS OF PAT IN TWO MECHANISTICALLY DISTINCT PAIN CONDITIONS: (I) A PREDOMINANTLY NOCIPLASTIC CONDITION, CHRONIC BACK PAIN, TESTING PSILOCYBIN COMBINED WITH AN EMERGING EVIDENCE-BASED THERAPY FOR NOCIPLASTIC PAIN—PAIN REPROCESSING THERAPY, AND (II) A PAIN CONDITION WITH A SUBSTANTIAL NOCICEPTIVE ELEMENT, CANCER-INDUCED BONE PAIN, TESTING LSD COMBINED WITH AN EXISTENTIAL PSYCHOTHERAPY. THE OVERARCHING HYPOTHESIS FOR THE UH3 PHASE STUDIES IS THAT PARTICIPANTS RANDOMIZED TO INTERVENTION ARM (MODERATE DOSE FOLLOWED BY HIGH DOSE PAT) WILL HAVE IMPROVED PAIN OUTCOMES COMPARED TO THE CONTROL ARM (PLACEBO FOLLOWED BY MODERATE DOSE PAT) AT ALL STUDY TIME POINTS (4,8,12 WEEKS) WITH A PRIMARY OUTCOME OF PAIN INTERFERENCE AT 8 WEEKS. IN ADDITION, GENERAL MEASURES OF MOOD, SLEEP, AND WELLBEING WILL BE IMPROVED IN THE INTERVENTION ARM COMPARED TO THE CONTROL ARM.

The Regents Of The Univ. Of Colorado

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.213 - Research and Training in Complementary and Integrative Health

National Institute on Aging (NIA) [HHS - NIH]

National Center for Complementary and Integrative Health (NCCIH) [HHS - NIH]

Colorado United States

State-Wide

Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required) (RFA-AG-25-004)

Amendment Since initial award the total obligations have increased 1600% from $200,000 to $3,399,999.