Status:
TERMINATED
Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
Lead Sponsor:
Lykos Therapeutics
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low d...
Detailed Description
This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy scheduled two to four weeks apart are safe, and whether combining a ful...
Eligibility Criteria
Inclusion
- Diagnosis of Posttraumatic stress disorder still remaining after at least one treatment, with treatment including psychotherapy or pharmacotherapy. At least two-thirds of participants will have PTSD as a result of war and terrorism
- May meet criteria for a mood disorder.
- Must be at least 18 years old.
- Must be able to stop taking psychiatric medication from the start of the study until the two-month follow-up.
- May continue seeing an outside therapist during the study, but cannot increase the length or frequency of treatments.
- Must be able to follow all the rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption
- Must be willing to stay overnight in the clinic after each experimental session until the non-drug session occurring the next morning.
- Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.
- If a woman of childbearing potential, must have a negative pregnancy test and must agree to use an effective form of birth control.
- Must be able to speak and read Hebrew.
Exclusion
- Cannot have history of or be diagnosed with psychotic disorder or bipolar affective disorder - 1.
- Cannot be diagnosed with dissociative identity disorder, an eating disorder with active purging, or borderline personality disorder.
- Cannot have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
- Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
- Cannot weigh less than 50 or more than 105 kg.
- Cannot have used "Ecstasy" more than five times during lifetime or in the past six months.
- Cannot present a serious suicide risk or be likely to require hospitalization during the course of the study.
- Cannot require ongoing concomitant therapy with a psychotropic drug.
- Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
- Unable to give adequate consent.
Key Trial Info
Start Date :
May 27 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00402298
Start Date
May 27 2007
End Date
May 5 2010
Last Update
June 5 2025
Active Locations (1)
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1
Be'er Ya'akov Mental Health Center
Be’er Ya‘aqov, Israel