Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT01458327
Eligibility Criteria:
Inclusion Criteria:
* Be diagnosed with chronic PTSD;
* Have a CAPS score showing moderate to severe PTSD symptoms;
* Have participated in MP-1;
* Are at least 18 years old;
* Must be generally healthy;
* Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
* Are willing to refrain from taking any psychiatric medications during the study period;
* Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
* Willing to remain overnight at the study site;
* Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
* Are willing to be contacted via telephone for all necessary telephone contacts;
* Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
* must provide a contact in the event of a participant becoming suicidal;
* Are proficient in speaking and reading English;
* agree to have all clinic visit sessions recorded to audio and video
* Agree not to participate in any other interventional clinical trials during the duration of this study.
Exclusion Criteria:
* Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
* Weigh less than 48 kg;
* Are abusing illegal drugs;
* Are unable to give adequate informed consent;
* Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
* Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01458327
Study Brief:
Protocol Section:
NCT01458327