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Mt. Pleasant, South Carolina 29464


Purpose:

This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising from being a victim of a crime.


Study summary:

Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. It is most likely to occur following an event involving perceived personal threat, such as rape or physical assault. PTSD is clearly a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs. This study will examine whether two sessions of methylenedioxymethamphetamine (MDMA)-assisted psychotherapy can be safely administered to participants with PTSD, and whether MDMA-assisted psychotherapy, when compared with placebo-assisted therapy, will reduce PTSD symptoms after each session and two months after the second session. MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Currently, MDMA is scheduled (illegal) and cannot be used outside of research studies like this one. Anecdotal reports of therapy conducted before MDMA was made illegal suggest that MDMA-assisted psychotherapy may benefit people with PTSD. This study will examine MDMA-assisted psychotherapy in twenty people ages 18 to 70 with PTSD either related to crime victimization or combat, when combat-related PTSD lasts no longer than five years, and that has not gotten better after psychotherapy and treatment with an SSRI (selective serotonin uptake inhibitor, such as Paxil). This study lasts three to four months. Participants attend up to fourteen (14) ordinary (non-drug) psychotherapy sessions with the investigators as well as two eight hour long experimental (MDMA or placebo) sessions and one MDMA session. People taking part in this study cannot take any psychiatric medication during the study period. People will either get 125 mg MDMA or placebo "by chance," as by coin-toss, with twelve of twenty (60%) getting MDMA during each experimental session, and eight of twenty (40%) getting placebo. Two to two and a half hours later, if you and the investigators agree it is alright, you will take a second supplemental, dose of MDMA or placebo. The supplemental dose will be half the size of the first dose. The same investigators conducting non-drug therapy sessions conduct the experimental sessions. All participants are required to stay the night at the clinic after each experimental session. Participants meet with the investigators for a non-drug assisted therapy session the day after each experimental session. A third MDMA session in this placebo-controlled stage of the study will only be for people who received MDMA in the first two sessions. PTSD symptoms are measured at the start of the study, four days after each experimental session, and finally two months after the second experimental session. People are tested on memory and problem solving when they first enter the study and again two months after the second experimental session. PTSD symptoms are measured to see whether there are any changes in symptoms during the study, and tests of thinking, memory and problem-solving are meant to spot any changes that could be due to MDMA or MDMA-assisted therapy. Participants who recieved MDMA who complete the final evaluation, and upon discussion with the investigators, will undergo a third MDMA session. The third session will happen approximately two months after the second experimental session This session is "open label," meaning that they and the investigators will both know they are receiving MDMA. It will be followed by one psychotherapy session a day after this session and two additional psychotherapy sessions in the following weeks. PTSD symptoms will be measured again two months after the third MDMA session. Participants who received placebo and complete the final evaluation two months after the second experimental procedure will be given an opportunity to take part in an open-label continuation of the study where they will receive an initial dose of 125 mg MDMA and a supplemental dose of 62.5 mg MDMA in up to three experimental sessions scheduled three to five weeks apart. Participants in this open-label continuation will act as their own controls. The open-label continuation lasts three months and will involve nine more visits with the investigators, including the two experimental sessions.


Criteria:

Inclusion Criteria: - Diagnosed with PTSD as a result of crime victimization or as a result of combat if symptoms have lasted for no longer than five years. - Very little or no improvement in PTSD signs or symptoms after three months' treatment with a selective serotonin uptake inhibitor (SSRI) and little or no improvement after six months' treatment with any form of psychotherapy for which there there is evidence from a controlled trial that this type of therapy efficacious (good for treating) PTSD. - Must be willing to attend all sessions, and to take MDMA or placebo. - If you are seeing another psychotherapist, you must be willing to give the principal investigator permission to communicate with him or her. - Must be willing to stop taking any psychiatric medications during the study period. Drugs will be tapered in an appropriate fashion to avoid withdrawal effects. Participants must not start any new medications until after the evaluation session, which will occur 2 months after the second experimental session. - Must be willing to remain overnight at the clinic after each experimental session until the non-drug session occurring the next morning. An attendant will be present to assist with personal needs if requested and offer dinner and breakfast. The attendant will be a registered nurse (RN) and of the same sex as the participant, and he or she will be trained for assisting in this study. - Participants must be willing to be contacted via telephone on a daily basis by one of the investigators for a week after each experimental session. - Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control. - Participants must be literate. They must be proficient in reading documents written in English. Exclusion Criteria: - People with a non-crime or non-war related traumatic event that makes a significant contributor to their PTSD symptoms, as assessed by the CAPS. - Women who are pregnant or nursing, or who are able to get pregnant and are not practicing an effective means of birth control. - People with a history of or current primary psychotic disorder or bipolar affective disorder type 1. - People with dissociative identity disorder or an eating disorder with active purging, or borderline personality disorder. - People with hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia. - People with evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (Participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). - Weighing less than 50 kg (110 lb) or more than 105 kg (230 lb). - People who reported they used "Ecstasy" (material represented as MDMA) more than 5 times or at any time within the previous 6 months. - People who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. - People requiring ongoing concomitant therapy with a psychotropic drug. - People diagnosed with substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days. - Any person who is not able to give adequate informed consent.


NCT ID:

NCT00090064


Primary Contact:

Principal Investigator
Michael Mithoefer, MD
Private practice


Backup Contact:

N/A


Location Contact:

Mt. Pleasant, South Carolina 29464
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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