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Last Updated: November 15, 2019

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CLINICAL TRIALS PROFILE FOR DIMETHYLTRYPTAMINE

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Clinical Trials for Dimethyltryptamine

Trial ID Title Status Sponsor Phase Summary
NCT00465595 Psychopharmacology of Psilocybin in Cancer Patients Active, not recruiting Heffter Research Institute N/A 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 Active, not recruiting Sidney Kimmel Comprehensive Cancer Center N/A 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 Active, not recruiting New York University Phase 1/Phase 2 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.
NCT01943994 Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study Recruiting Beckley Foundation N/A One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence. We propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependent individuals in order to provide preliminary data on the efficacy of this combined treatment for smoking cessation. Prior work in our laboratory has shown that under carefully prepared and supportive conditions, psilocybin administration can facilitate highly salient experiences with enduring personal meaning and spiritual significance (Griffiths et al., 2006, 2008). It is plausible that embedding such highly meaningful experiences into a drug dependence cessation attempt may provide an enduring motivation for remaining abstinent. Cigarette smoking is a good model system for studying drug dependence because users are less likely to be challenged by the many social and economic impairments that often accompany dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, we propose to conduct a randomized controlled comparative efficacy study in which either psilocybin or transdermal nicotine patch are administered under highly supportive conditions to individuals who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit attempts, and who continue to desire to quit smoking. Other than nicotine dependence, participants will be healthy. Fifteen participants have already completed a preliminary open-label pilot-study with no control condition. Fifty additional participants will be enrolled and randomized to either psilocybin (n=25), or nicotine patch (n=25) treatment. Participants will receive a 13-week course of cognitive behavioral therapy for smoking cessation, with Target Quit Date set for week 5. After several preparation meetings with study monitors, participants will have either a single day-long psilocybin session using a high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment. Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit Date, including biological verification of smoking status through breath and urine samples. Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12 months after the Target Quit Date. Additionally, participants will undergo MRI scanning before and after Target Quit Date to assess the brain-based mechanisms associated with these treatments. Individuals assigned to the nicotine patch study treatment condition will be eligible to undergo an optional high dose psilocybin session after completing the 6-month follow-up meeting.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Dimethyltryptamine

Condition Name

Condition Name for
Intervention Trials
Cancer 2
Healthy 2
Major Depression 1
Anxiety 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Depression 3
Depressive Disorder, Major 2
Tobacco Use Disorder 1
Depressive Disorder 1
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Clinical Trial Locations for Dimethyltryptamine

Trials by Country

Trials by Country for
Location Trials
United States 5
Brazil 1
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Trials by US State

Trials by US State for
Location Trials
Maryland 3
Wisconsin 1
New York 1
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Clinical Trial Progress for Dimethyltryptamine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 1
Phase 1/Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 3
Not yet recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for Dimethyltryptamine

Sponsor Name

Sponsor Name for
Sponsor Trials
Heffter Research Institute 3
Johns Hopkins University 2
Stupski Foundation 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 17
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