Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Randomized, double-blind, placebo-controlled Phase II study (n=6) comparing MDMA-assisted therapy (125 mg initial + 62.5 mg supplemental per experimental session, two blinded sessions) versus placebo with therapy in adults with chronic, treatment-resistant PTSD.
Detailed Description
This randomized, double-blind, placebo-controlled study randomizes participants to MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart; primary outcome assessed by CAPS-IV.
Each experimental session uses split dosing (125 mg MDMA HCl initial dose followed by 62.5 mg supplemental dose). Participants receive preparatory psychotherapy sessions prior to dosing and integration sessions after dosing; safety and secondary clinical measures are assessed throughout.
After unblinding, participants originally assigned to MDMA may receive an open-label third MDMA-assisted session; participants assigned to placebo may have the option to enter Stage 2 to explore titrated MDMA dosing.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted therapy
experimentalMDMA-assisted therapy during two blinded experimental sessions (Stage 1); participants in MDMA arm may receive an open-label third session after unblinding.
Interventions
- MDMA125 mgvia Oral• split dose per session• 2 doses total
125 mg initial followed by 62.5 mg supplemental per experimental session; two blinded sessions in Stage 1; optional open-label third session after unblinding.
- Compound
Preparatory and integration psychotherapy sessions provided pre- and post-dosing.
Placebo with therapy
inactivePlacebo with the same psychotherapy schedule during two blinded experimental sessions; option to enter Stage 2 after unblinding.
Interventions
- Placebo
Placebo administered in two blinded experimental sessions.
- Compound
Preparatory and integration psychotherapy sessions provided pre- and post-dosing.
Participants
Inclusion 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
- 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.