- Phase II Dose-Response Pilot Study of +/-3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects with Anxiety Associated with Advanced-Stage Cancer
Dear _____,
I am seeking patients with advanced stage cancer who continue to experience diagnosis-related anxiety to participate in a research study currently underway at McLean Hospital. We hope that you might be interested in referring patients to us. The study is a Phase 2 randomized, double-blind, dose-response study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in people with anxiety associated with advanced stage cancer. MDMA is a Schedule I substance and is also known by its illicit name “Ecstasy.” Co-investigators include oncologist Dr. Todd Shuster of the Lahey Clinic Medical Center, Dr. Arthur Siegel, Director of Internal Medicine of McLean Hospital, and Dr. Pedro Huertas, palliative care medicine internist, McLean Hospital.
We are seeking cancer patients who have not adequately responded to standard, FDA-approved treatments for anxiety (such as use of benzodiazepines and antidepressants) or psychotherapy, or patients who complain of undesirable side-effects from these medications, such as over-sedation. This present study may lead to new, improved methods for treating these patients.
Anecdotal accounts of people with advanced-stage cancer who have participated in MDMA-assisted psychotherapy, suggest that this novel approach might effectively reduce anxiety, improve quality of life, help individuals repair or improve relationships, and enhance their ability to consider issues of spirituality or life meaning. An FDA-approved Phase 2 pilot study of MDMA-assisted psychotherapy in subjects with treatment-resistant posttraumatic stress disorder (PTSD) is also generating promising results (and is being led by other researchers in South Carolina).
Our investigation is open to twelve people age 18 or older with advanced stage cancer. Active clinical anxiety is, as mentioned, related to living with cancer diagnosis and related end-of-life issues and should not be part of an anxiety disorder that predates cancer diagnosis. Eight of twelve people will be randomized to the Experimental Dose Group, and four of 12 will be randomized to the Threshold Dose Group. Study participants will undergo two eight-hour MDMA-assisted sessions with a female co-therapist, Dr. Huertas, and myself and which will include an overnight stay at McLean Hospital. These experimental-intervention sessions will be scheduled two to four weeks apart. There are also preparatory and follow-up non-drug psychotherapy sessions with these investigators. At all non-drug sessions we will assess anxiety, depression, feelings of hopelessness, spirituality and quality of life, with the final assessment occurring two months after the second experimental session. Participants will also maintain a daily record of pain, anxiety, and use of pain management and anxiolytic medications during the course of the study.
Participants assigned to Threshold Dose Group will also have the option to continue in a study extension with open-label MDMA at the dosage levels that the eight people receive in the Experimental Dose Group. A study extension will provide potential additional data on the MDMA doses we are interested in exploring without having to recruit additional subjects.
Inclusion criteria include diagnosis of advanced stage cancer with an associated prognosis for their cancer staging, DSM-IV diagnosis of an anxiety disorder associated with the stress of cancer diagnosis that does not pre-date the cancer diagnosis; being at least 18 years old; failing to respond adequately to anxiolytic medication or refusal to use such medications; completion of all cytotoxic/radiologic cancer therapies or decision to suspend these therapies in the weeks surrounding the two MDMA treatment sessions; the capability and willingness to travel to the Lahey Clinic Medical Center’s Medical Oncology service (located in Burlington, MA) to meet with Dr. Todd Shuster, who will complete a medical chart review, physical, ordering and reviewing of laboratory values and ECG to screen candidates for study inclusion; and the capability and willingness to travel to McLean Hospital for baseline psychiatric evaluation, non-drug psychotherapy sessions, MDMA-assisted psychotherapy with overnight stay, and final study visit.
Exclusion criteria include diagnosis of dissociative disorder, eating disorders with bingeing or purging, psychosis, or active anxiety disorders pre-dating cancer diagnosis; meeting DSM-IV criteria for abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days; if female, being pregnant or failing to use effective means of birth control; primary or metastatic cancer of the CNS; other serious medical conditions, especially cerebrovascular or cardiovascular conditions including hypertension; baseline laboratory values indicative of severely compromised hepatic function; weighing less than 45 kg; and inability to give informed consent.
Study participants will not be paid for taking part in the study. We will pay for all tests and measures used to determine study eligibility. Transportation, if needed, will also be paid for by the study. Experimental-intervention sessions require overnight stay at McLean Hospital: we will provide overnight accommodations and all meals and snacks for the subject and a significant support person of the subject’s choosing on those days.
If you wish to review and discuss any aspect of this study protocol, and if you especially are interested in referring one or more of your patients to us, please contact me, Dr. John Halpern, principal investigator of this study, or co-investigator Dr. Pedro Huertas, the palliative care medicine internist who will help coordinate referrals for the first evaluation visit at the Lahey Clinic Medical Center. If your patients are interested in participating, we will need a supporting letter from you and a copy of your CV for submission to the McLean Hospital IRB. Interested patients will also have to complete a medical records release form so that Dr. Huertas can carefully review inclusion/exclusion criteria with you and coordinate communication of information throughout study participation between you and the research team.
To learn more, please call 1-800-444-0601 9am-5pm or email at john_halpern@hms.harvard.edu.
Sincerely,
John H. Halpern, M.D.
I am seeking patients with advanced stage cancer who continue to experience diagnosis-related anxiety to participate in a research study currently underway at McLean Hospital. We hope that you might be interested in referring patients to us. The study is a Phase 2 randomized, double-blind, dose-response study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in people with anxiety associated with advanced stage cancer. MDMA is a Schedule I substance and is also known by its illicit name “Ecstasy.” Co-investigators include oncologist Dr. Todd Shuster of the Lahey Clinic Medical Center, Dr. Arthur Siegel, Director of Internal Medicine of McLean Hospital, and Dr. Pedro Huertas, palliative care medicine internist, McLean Hospital.
We are seeking cancer patients who have not adequately responded to standard, FDA-approved treatments for anxiety (such as use of benzodiazepines and antidepressants) or psychotherapy, or patients who complain of undesirable side-effects from these medications, such as over-sedation. This present study may lead to new, improved methods for treating these patients.
Anecdotal accounts of people with advanced-stage cancer who have participated in MDMA-assisted psychotherapy, suggest that this novel approach might effectively reduce anxiety, improve quality of life, help individuals repair or improve relationships, and enhance their ability to consider issues of spirituality or life meaning. An FDA-approved Phase 2 pilot study of MDMA-assisted psychotherapy in subjects with treatment-resistant posttraumatic stress disorder (PTSD) is also generating promising results (and is being led by other researchers in South Carolina).
Our investigation is open to twelve people age 18 or older with advanced stage cancer. Active clinical anxiety is, as mentioned, related to living with cancer diagnosis and related end-of-life issues and should not be part of an anxiety disorder that predates cancer diagnosis. Eight of twelve people will be randomized to the Experimental Dose Group, and four of 12 will be randomized to the Threshold Dose Group. Study participants will undergo two eight-hour MDMA-assisted sessions with a female co-therapist, Dr. Huertas, and myself and which will include an overnight stay at McLean Hospital. These experimental-intervention sessions will be scheduled two to four weeks apart. There are also preparatory and follow-up non-drug psychotherapy sessions with these investigators. At all non-drug sessions we will assess anxiety, depression, feelings of hopelessness, spirituality and quality of life, with the final assessment occurring two months after the second experimental session. Participants will also maintain a daily record of pain, anxiety, and use of pain management and anxiolytic medications during the course of the study.
Participants assigned to Threshold Dose Group will also have the option to continue in a study extension with open-label MDMA at the dosage levels that the eight people receive in the Experimental Dose Group. A study extension will provide potential additional data on the MDMA doses we are interested in exploring without having to recruit additional subjects.
Inclusion criteria include diagnosis of advanced stage cancer with an associated prognosis for their cancer staging, DSM-IV diagnosis of an anxiety disorder associated with the stress of cancer diagnosis that does not pre-date the cancer diagnosis; being at least 18 years old; failing to respond adequately to anxiolytic medication or refusal to use such medications; completion of all cytotoxic/radiologic cancer therapies or decision to suspend these therapies in the weeks surrounding the two MDMA treatment sessions; the capability and willingness to travel to the Lahey Clinic Medical Center’s Medical Oncology service (located in Burlington, MA) to meet with Dr. Todd Shuster, who will complete a medical chart review, physical, ordering and reviewing of laboratory values and ECG to screen candidates for study inclusion; and the capability and willingness to travel to McLean Hospital for baseline psychiatric evaluation, non-drug psychotherapy sessions, MDMA-assisted psychotherapy with overnight stay, and final study visit.
Exclusion criteria include diagnosis of dissociative disorder, eating disorders with bingeing or purging, psychosis, or active anxiety disorders pre-dating cancer diagnosis; meeting DSM-IV criteria for abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days; if female, being pregnant or failing to use effective means of birth control; primary or metastatic cancer of the CNS; other serious medical conditions, especially cerebrovascular or cardiovascular conditions including hypertension; baseline laboratory values indicative of severely compromised hepatic function; weighing less than 45 kg; and inability to give informed consent.
Study participants will not be paid for taking part in the study. We will pay for all tests and measures used to determine study eligibility. Transportation, if needed, will also be paid for by the study. Experimental-intervention sessions require overnight stay at McLean Hospital: we will provide overnight accommodations and all meals and snacks for the subject and a significant support person of the subject’s choosing on those days.
If you wish to review and discuss any aspect of this study protocol, and if you especially are interested in referring one or more of your patients to us, please contact me, Dr. John Halpern, principal investigator of this study, or co-investigator Dr. Pedro Huertas, the palliative care medicine internist who will help coordinate referrals for the first evaluation visit at the Lahey Clinic Medical Center. If your patients are interested in participating, we will need a supporting letter from you and a copy of your CV for submission to the McLean Hospital IRB. Interested patients will also have to complete a medical records release form so that Dr. Huertas can carefully review inclusion/exclusion criteria with you and coordinate communication of information throughout study participation between you and the research team.
To learn more, please call 1-800-444-0601 9am-5pm or email at john_halpern@hms.harvard.edu.
Sincerely,
John H. Halpern, M.D.
Institution – McLean Hospital, Belmont, MA
Principal Investigator – John H Halpern, MD
Enrollment Information
For further information about enrolling a patient in this trial, contact the person below.
Name – John H Halpern, MD
Email – john_halpern@hms.harvard.edu
Phone – 617-855-3703
