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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01958593
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with moderate to severe PTSD;
* Have chronic PTSD, defined as persisting for longer than 6 months;
* Have treatment-resistant PTSD, meaning unable to achieve remission despite previous therapy or medication or discontinued treatment due to inability to tolerate previous therapy or medication;
* Are willing to refrain from taking any psychiatric medications during the study period;
* Willing to remain overnight at the study site;
* Agree to have transportation home after experimental sessions;
* 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;
* Are proficient in speaking and reading English;
* Agree not to participate in any other interventional clinical trials during the duration of this study.
Exclusion Criteria:
* Are pregnant or nursing, or if of child bearing potential, are not practicing an effective means of birth control;
* Weigh less than 48 kg;
* 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;
* Have used "Ecstasy" (illicit drug preparations purported to contain MDMA) more than five times in the last 10 years or at least once within six months of enrollment;
* 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:
21 Years
Study:
NCT01958593
Study Brief:
Protocol Section:
NCT01958593