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| Sponsor: | Brigham and Women's Hospital |
|---|---|
| Collaborator: |
Mclean Hospital |
| Information provided by: | Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00252174 |
Purpose
This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is safe and can help people with advanced stage cancer and anxiety arising from the cancer diagnosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder Cancer |
Drug: 3,4-methylenedioxymethamphetamine (MDMA) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Dose-response Pilot Study of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Anxiety Associated With Advanced-stage Cancer. |
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stage 1, Active
8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
|
Drug: 3,4-methylenedioxymethamphetamine (MDMA)
Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg. |
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Active Comparator: Stage 1, Control
4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
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Drug: 3,4-methylenedioxymethamphetamine (MDMA)
Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg. |
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Experimental: Stage 2, Active
The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.
|
Drug: 3,4-methylenedioxymethamphetamine (MDMA)
Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg. |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John H. Halpern, M.D. | 617-855-2911 | john_halpern@hms.harvard.edu |
| United States, Massachusetts | |
| McLean Hospital | Recruiting |
| Belmont, Massachusetts, United States, 02478-9106 | |
| Contact: John H Halpern, MD 617-855-3703 john_halpern@hms.harvard.edu | |
| Principal Investigator: John H Halpern, MD | |
| Principal Investigator: | John H Halpern, MD | Mclean Hospital |
More Information
| Responsible Party: | John H. Halpern, M.D., Director of The Laboratory for Integrative Psychiatry, Division of Alcohol and Drug Abuse, McLean Hospital |
| ClinicalTrials.gov Identifier: | NCT00252174 History of Changes |
| Other Study ID Numbers: | 76,770 |
| Study First Received: | November 9, 2005 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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MDMA cancer anxiety psychotherapy quality of life |
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Anxiety Disorders Mental Disorders N-Methyl-3,4-methylenedioxyamphetamine Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Uptake Inhibitors |