CLINICAL TRIALS PROFILE FOR N,N-DIMETHYLTRYPTAMINE

Clinical Trials for N,N-Dimethyltryptamine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00465595 ↗	Psychopharmacology of Psilocybin in Cancer Patients	Completed	Heffter Research Institute	Phase 2	This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
NCT00465595 ↗	Psychopharmacology of Psilocybin in Cancer Patients	Completed	Johns Hopkins University	Phase 2	This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
NCT00465595 ↗	Psychopharmacology of Psilocybin in Cancer Patients	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
NCT00957359 ↗	Psilocybin Cancer Anxiety Study	Completed	New York University	Early Phase 1	The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license. It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.

Clinical Trial Conditions for N,N-Dimethyltryptamine

Condition Name

Condition Name for
Intervention	Trials
Healthy	6
Major Depressive Disorder	3
Pharmacokinetics in Healthy Adults	2
Anxiety	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Depression	11
Depressive Disorder	8
Depressive Disorder, Major	5
Depressive Disorder, Treatment-Resistant	2

Clinical Trial Locations for N,N-Dimethyltryptamine

Trials by Country

Trials by Country for
Location	Trials
United States	11
United Kingdom	6
Switzerland	5
Brazil	3
Netherlands	3

Trials by US State

Trials by US State for
Location	Trials
Maryland	5
California	3
Kansas	1
Wisconsin	1
New York	1

Clinical Trial Progress for N,N-Dimethyltryptamine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	8
Phase 1/Phase 2	4
Phase 1	13

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	18
Completed	6
Not yet recruiting	5

Clinical Trial Sponsors for N,N-Dimethyltryptamine

Sponsor Name

Sponsor Name for
Sponsor	Trials
Johns Hopkins University	5
University Hospital, Basel, Switzerland	3
Universidade Federal do Rio Grande do Norte	3

Sponsor Type

Sponsor Type for
Sponsor	Trials
Other	40
Industry	9