U.S.A

MDMA-Assisted Therapy in People with Anxiety Related to Advanced Stage Cancer

Sponsors and Collaborators: Brigham and Women’s Hospital, Peter Lewis
ClinicalTrials.gov Identifier: NCT00252174
Location: McLean Hospital, Belmont, Massachusetts
Contact: John H Halpern, MD, 617-855-3703, john_halpern (at) hms.harvard.edu

This study is examining the effects of MDMA-assisted psychotherapy in 12 people aged 18 or older who have received a diagnosis of advanced stage cancer (usually meaning inoperable and with metastases) who have anxiety as a result of this diagnosis that is either not helped by conventional anti-anxiety medication (such as Xanax or Valium), or who do not wish to take these medications because of their side effects. All participants receive an initial dose of MDMA followed by a second (supplemental) dose approximately two and a half hours later if the initial dose does not produce any problems. Eight of twelve participants get 83.3 mg MDMA followed by 47.1 mg the first time, and 125 mg followed by 67.5 mg the second time. Four of twelve receive 25 mg followed by 12.5 mg MDMA. Whether a person receives lower doses or higher doses of MDMA will be decided at random, as if by coin toss, and none of the researchers will know which dose of MDMA a person will get. The study lasts 14 weeks (about three and a half months). All participants will have seven (7) hour-long psychotherapy sessions and two MDMA-assisted psychotherapy sessions that will last six to eight hours and require an overnight stay at the treatment facilities.

Psychopharmacology of Psilocybin in Cancer Patients

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center, Heffter Research Institute
ClinicalTrials.gov Identifier: NCT00465595
Location: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus
Contact: Mary Cosimano, MSW , 410-550-5990, mcosima1 (at) jhmi.edu

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. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes.

An earlier study that was done in the same lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. The current study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 70 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.

New York University Psilocybin & Cancer

The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin on psychosocial distress, with the specific primary outcome variable being anxiety associated with advanced cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes toward disease progression, quality of life, and spiritual/mystical states of consciousness. Although the outcome measures will be similar to those used in the Harbor-UCLA study run by Dr. Grob, the proposed dose of psilocybin will be somewhat higher at 0.3mg/kg and the total subjects for this study will be 32 instead of 12. Stephen Ross, M.D., is the Principal Investigator of this project and subject enrollment began in April, 2009. For more information and details regarding this study or to discuss the referral of a patient, please call Krystallia Kalliontzi, M.Sc., Clinical Research Coordinator, at (212) 998-9252 or by email at kk71@nyu.edu.

Psilocybin in the Treatment of Obsessive-Compulsive Disorder

This study is the first clinical use of a psychedelic in the United States in more than 30 years. All the patients were beyond the reach of standard treatments, and all responded well. One patient had symptom remission for weeks following one psilocybin session. This study shows a potential breakthrough treatment for obsessive-compulsive disorder, a recalcitrant disease that is the fourth most common outpatient psychiatric problem. The study was conducted by Dr. Francisco Moreno, M.D. at the University of Arizona Medical Center, and published in 2006.

Johns Hopkins University Psilocybin & Cancer

44 cancer patients will receive psilocybin treatment similar to that in Dr. Grob’s study, except that it includes early-stage cancer patients and a different research design that involves two psilocybin sessions and higher doses of psilocybin. This study specifically focuses on spiritual experience facilitated by psilocybin as a healing factor in patients who are psychologically distressed by their cancer diagnosis. Patients with and without disease progression are eligible. Outcome measures include measures of mystical/spiritual experience, quality of life, anxiety, depressed mood, attitude about death, use of pain medication, and blood markers of stress and immune function. Subject recruiting is ongoing, and potential subjects can be referred to the study coordinator, Mary Cosimano at (410) 550-5990, or by email to: Roland Griffiths.

Johns Hopkins University Psilocybin & Spirituality

This study is a follow-up to their widely publicized project published last year by Dr. Roland Griffiths and colleagues: Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. This follow-up phase follows the same model as the first study, but uses different doses of psilocybin. It was funded by an anonymous donor to the Heffter Research Institute. MAPS been a critical part of this groundbreaking research to demonstrate the benefits of psychedelics to humanity.

A Pilot Study of Psilocybin-Facilitated Addiction Treatment.

Investigators. Roland Griffiths PhD, Matt Johnson PhD,
Sponsor: Beckley Foundation
This study focuses on overcoming nicotine addiction in cigarette smokers. Psilocybin will be administered under highly supportive conditions to individuals who suffer drug dependence that has been resistant to treatment by conventional means. Participants will undergo several preparation meetings with session guides before two, day-long psilocybin sessions with a week’s gap between them. Participants will meet with session guides the day after each session and weekly for 3 weeks after the last psilocybin session. To maximise the benefits of this research, we will also be looking to test the proposal that hallucinogen-induced mystical experiences may boost the immune system and thereby have important implications for health and well-being, by measuring cytokine markers of immune function before the first and after the last psilocybin session.

Case Series: Response of Cluster Headache to Self-Administered Lysergic-Acid-Amide-Containing Seeds

Investigator: R. Andrew Sewell MD. Inspired by reports from the cluster headache community that ingestion of seeds containing LSA (Hawaiian baby woodrose, morning glory, Rivea corymbosa) terminates cluster periods in the same way that LSD and psilocybin do, this study will examine the effects of LSA on cluster headache by collecting accounts from patients who have used these seeds to control their symptoms, and will also analyze the seeds that they used in order to determine the LSA content. Psilocybin and LSD in the treatment and prevention of cluster headaches Investigators: Dr. John Halpern Location: Harvard Medical School, McLean Hospital, Belmont, MA.

Johns Hopkins Study of Psilocybin in Cancer Patients

Investigators: Roland Griffiths PhD, William Richards PhD, Matthew Johnson, Ph.D., Una McCann, M.D. Sponsor: Heffter Research Institute, Riverstyx Foundation Contact: Roland Griffiths PhD This study is being done to find out if psilocybin can produce personally and spiritually meaningful experiences in cancer patients, thereby extending findings from an earlier study in our laboratory with healthy volunteers. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. The study will enroll about 44 people, who will receive careful preparation and 2 sessions in which they will receive psilocybin. Structured guidance will be provided during the session and afterward to facilitate integration of the experiences.

Effects of Psilocybin on Healthy Volunteers

Investigators: Roland Griffiths PhD, William Richards PhD, Una McCann MD, Robert Jesse
Sponsor: NIDA, Council for Spiritual Practices, Heffter Research Institute

A series of studies is planned to investigate the effects of psilocybin in healthy volunteers. The first was a double-blind study evaluating the psychological effects of 30 mg/70 kg psilocybin relative to methylphenidate, 40 mg/70 kg administered under comfortable, supportive conditions to 36 hallucinogen-naive adults reporting regular participation in religious or spiritual activities. After psilocybin, 61% of the volunteers met pre-established criteria, as measured on standardized scales, for a full mystical experience, and 31% reported significant fear sometime during their psilocybin session. Two months after sessions, 71% of the volunteers rated their psilocybin experience as among the five most “spiritually significant” experiences of their lifetimes. Seventy-nine percent of volunteers rated that it had increased their current sense of personal well being or life satisfaction. Community observer (family, friends, coworkers) ratings tended to confirm this. Fourteen month follow-up data is being analyzed.

The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury

Barth Wilsey, M.D. at University of California, Davis

ABSTRACT:

The present study will be designed to evaluate the analgesic effects of vaporized cannabis in patients with neuropathic pain due to spinal cord injury. A within-subject crossover study of the effects of cannabis (3.5% and 1.7%) versus placebo on spontaneous and evoked pain will be performed. Both pain intensity and pain unpleasantness will be assessed to see if marijuana affects sensory-discriminative pain more or less than the motivational-affective component. If present, areas of mechanical allodynia will be assessed with repeated testing to determine the degree of the allodynia regression (if any) after inhaling cannabis via a vaporizer. Heat evoked pain will be studied using mild to moderately painful heat stimuli delivered to the painful area of the subject’s body using an electronically controlled Peltier contact thermode via the Medoc TSA 2001 quantitative sensory tester. Neuropsychological functioning (attention, learning and memory, and psychomotor performance) will be evaluated with the Digit Symbol Modalities Test, the Hopkins Verbal Learning Test and the Grooved Pegboard Test before and after the administration of vaporized cannabis. The degree of antinociception will then be compared with neuropsychological effects of cannabis for a synopsis of the relative effectiveness (efficacy versus side-effects) of the doses employed.

The hypothesis will be that vaporized cannabis can induce dose dependent antinociceptive changes in spontaneous and evoked pain in subjects with neuropathic pain. The second hypothesis will be that the higher dose employed induce a greater degree of antinociception that is not independent of differences in mood, cognition and psychomotor performance. Finally, it is hypothesized that an interaction with time will occur such that antinociception will outlast changes in cognitive impairment and psychomotor performance.

Efficacy of Inhaled Cannabis in Diabetic Peripheral Neuropathy

Mark Wallace, M.D. at University of California, San Diego

ABSTRACT:

Neuropathic pain is caused by an insult to the nervous system and accounts for 25-50% of all pain clinic visits. Excluding low back pain, diabetic peripheral neuropathy is the most common neuropathic pain syndrome with an estimated prevalence of 600,000 cases in the United States. There are only 5 medications approved by the FDA for the treatment of neuropathic pain with only 2 out of the 5 approved for the treatment of diabetic peripheral neuropathy. Currently, there is a desperate need for more therapeutic agents for the treatment of neuropathic pain. We propose to use painful diabetic peripheral neuropathy (DPN) patients to study the efficacy of inhaled cannabis on neuropathic pain. We will enroll 20 subjects with each subject acting as their own control; receiving both placebo and three doses of inhaled aerosolized cannabis (low, medium, and high) in random order each separated by at least two weeks. Subjects will be assessed for reduction in pain, changes in normal sensation, changes in cognition, and effects of cannabis on experimentally induced pain. Our hypothesis is as follows:

1. Cannabis will result in a dose dependent decrease in the spontaneous pain and qualitative pain descriptors.
2. Cannabis will have no effect on acute sensory thresholds as measured by the QST.
3. Pain relief will occur at cannabis doses that do not significantly affect cognitive function.

Cannabis will decrease experimental pain as measured by the BTS. The effect on the BTS will correlate with the decrease in spontaneous pain of DPN.