Current Psychedelic Research in Patient PopulationsFebruary 11, 2009 8:09 pm hallucinogen, human
Here is a list of four human psychedelic studies that are currently recruiting participants. These are all seeking people with specific illnesses. Most of these details were obtained from ClinicalTrials.gov and maps.org
Study of 3,4-Methylenedioxymethamphetamine-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Sponsors and Collaborators: Multidisciplinary Association for Psychedelic Studies,
Swiss Medical Association for Psycholytic Therapy
ClinicalTrials.gov Identifier: NCT00353938
Location: Solothurn (Switzerland)
Contact: Peter G Oehen, MD 0041-32-672-0606, peter.oehen (at) hin.ch
Contact: Verena Widmer 0041-32-672-0606
This study is a randomized, double-blind comparison of low versus experimental doses of MDMA in 12 people with treatment-resisted PTSD, with eight people receiving 125 mg followed by 62.5 mg MDMA, and four people receiving 25 mg followed by 12.5 mg MDMA. Everyone will receive three separate experimental sessions during a full course of psychotherapy. PTSD symptoms before the study will be compared with symptoms after two sessions and after all three sessions, and all people who received 125 mg will have symptoms measured again 6 and 12 months after the final experimental session. People who received low dose MDMA will have an opportunity to take part in a second open-label continuation. Ten subjects are enrolled as of November 2008, and two have been enrolled in Stage 2.
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.
LSD-assisted psychotherapy for 12 people with anxiety related to life-threatening illness
Sponsor: Multidisciplinary Association for Psychedelic Studies (MAPS)
ClinicalTrials.gov Identifier: none
Location: Solothurn, Switzerland
Contact: Peter Gasser MD, pgasser (at) gmx.met
This research will study the safety and efficacy of LSD-assisted psychotherapy in reducing anxiety arising from diagnosis with a serious illness and limited life expectancy, in 12 participants in Switzerland by Dr. Peter Gasser. The study is primarily intended to meet two goals. The first is to discover whether LSD-assisted psychotherapy can be safely administered to individuals with a severe prognosis and short estimated life expectancy who suffer from anxiety related to their diagnosis and the severity of their disease or condition. The second goal is to determine whether this therapy will produce improvements in symptoms of anxiety, using the Spielberger State Trait Anxiety Inventory (STAI) as a primary outcome measure of anxiety. The study’s annual report can be found here.
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.