MDMA Assisted Therapy for Bulimia Nervosa: A Treatment Development Protocol
This project will evaluate MDMA Assisted Therapy (MDMA-AT) assisted psychotherapy for the treatment of Bulimia Nervosa (BN) over a 10-week period. Preliminary data suggests that MDMA can facilitate heightened openness and reduce anxiety. This study will determine whether MDMA-assisted therapy can serve as a new treatment for BN. Participants are assigned to one of three groups: MDMA-AT, MDMA-AT-BN, and Standard Treatment (ST). MDMA groups include three experimental session that include dosing, which are each followed by three integrative sessions and also include 12 psychotherapy sessions. A follow-up will take place at 6-months post baseline.
⁃ Participants will be included in the protocol if they meet the following criteria:
• At least 18 years of age
• Meet criteria for Bulimia Nervosa as measured by the EDA-5
• Able to provide written, informed consent
• Able to swallow pills
• Agree to have study visits recorded, including Experimental Sessions and non-medication therapy sessions
• Provides a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
• Agrees to inform the investigators within 48 hours of any medical conditions and procedures
• If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods through 10 days after the last Experimental Session. Adequate contraceptive methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). 'Not able to become pregnant' is defined as permanent sterilization, postmenopausal, or assigned male at birth
• Agrees to the lifestyle modifications
• Live within reasonable driving distance of the study site (equal to or less than an estimated 2-hour drive from the study site).
• Have an identified Primary Care Physician (PCP) and provide consent for the investigator to communicate with PCP, as needed.
• Current or past treatment were not successful to retain remission (i.e., continued to meet criteria for BN) despite participating in at least one ED-specific episode of treatment (inpatient, residential, partial hospitalization, intensive outpatient), as confirmed by medical records, by a general practitioner, or by a specialist in ED.
• Are medically stable according to screening 12-lead Electrocardiogram (ECG), blood pressure monitoring, blood and urine laboratory screening results, and medical history.