MDMA-assisted psychotherapy in the treatment of trauma

Phase 2

• Conditions: Post-traumatic stress disorder (PTSD); F43.1

• Registration Number: RBR-6sq4c9
• Lead Sponsor: Instituto Plantando Consciência

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Fulfill PTSD criteria according to DSM IV, lasting at least six months; CAPS score equal or superior to 60 points, indicating moderate to severe symptoms; At least 18 years old completed; Previous attempts to relief PTSD symptoms with other therapies, without success; If on current psychotherapeutic treatment in the moment of study inclusion, participants can keep this psychotherapy. Participants in this situation must sign a permission for researchers to directly communicate with the psychotherapist outside the study team. Participants can not change therapist, increase frequency of therapy or start new therapy until the final evaluation which will happen two months after the last MDMA session. Participants who live at a distance which requires more than two hours driving to the study site must have a local therapist in their home town who can provide support in case of need. Participants are willing to abdicate the use of any psychiatric medications during the period of the study, exception made to gabapentin prescribed for pain management. In case of use of psychostimulants for ADHD in the study screening, they can keep the same dose and regime provided medication is tapered off for 5.5 half-life before each MDMA session and must not restart this medication until 10 days have elapsed from each MDMA session. Any psychoactive drug, including psychostimulants, will be progressively discontinued in order to avoid abstinence symptoms. Any medication will only be discontinued after consultation with the physician who prescribed it. Agree to, one week before each MDMA session, to abdicate from: Use of any herb supplement (except in case of prior approval by research staff). Use of any non-prescription medication (exception made to non-sterodial anti-inflammatory drugs or paracetamol, except in case of prior approval by research staff). Use of any prescribed drug (exception made to contraceptive pills, tyroid hormones or other medications with previous approval of research staff). Agree to not ingest alcoholic beverages after 24:00 in the night previous to each MDMA session; Abdicate the use of any psychoactive drug, exception made to caffeine and nicotine, for 24 hours before each MDMA session; Agree to not use caffeine or nicotine for, respectively, two and six hours after MDMA administration; Agree to not drive or operate machinery for 24 hours after MDMA administration in each therapeutic session; Are willing to be contacted by phone in order for all the research monitorings to be conducted; Must present negative pregnancy test if fertile and agree to use effective contraceptive methods during the whole study, exception made to the long term follow up; Must present a contact person (family, husband or wife, close friend or another carer) who is willing to be contacted by the researchers in case the participant present signs that want to commit suicide; Must agree to inform the researchers before 48 hours after any medical condition appears; Are fluent in Portuguese and have basic education level (Ensino Médio) completed; Agree to have all preparatory, therapeutic and integration sessions recorded in audio and video. Agree to not take part in any other clinical trial while this one lasts.

Exclusion Criteria

Pregnant or lactating women, or women who can potentially get pregnant during the study and are not using efficacious contraceptive methods; Have history or are currently diagnosed with type 1 bipolar disorder or dissociative affective disorder; Have signs or history of coronary arterial disease, peripheral vascular disease, hepatic disease with hepatic enzyme alterations or any other medical condition that the research staff, including the Responsible Physician, concludes to increase risks in the administration of MDMA. Hypertension according to the Brazilian Cardiology Society (Nobre et al, 2010). Hepatic disease, with the exception of asymptomatic hepatitis C patients who have undergone successful treatment before inclusion in the study; Have 48 kg or less; History of hyponatremia or hyperthermia; Have serious risk of suicide, according to psychiatric interview, responses to C-SSRS and with the clinical judgement of researchers, or according to researchers clinical evaluation are under serious risk of hospitalization during the study; Present serious risk of harming others, according to psychiatric interview and screening and with contact with previous psychiatrist who has previously treated the patient; Has used ecstasy (street drug presented as containing MDMA) more than 10 times in the last ten years or at least once in the six months before the first therapeutic session; Require therapy with psychiatric drugs during this trial, exception to drugs mentioned in item 7 of the section 4.1.1, Inclusion Criteria Are classified, according to DSM IV criteria, as individuals with drug abuse or dependence in the last 60 days, exception made to caffeine and nicotine; Are not apt to adequately read and sign an informed consent; Have any history or problem associated with drug and alcohol abuse that may, in the opinion of the researchers or the Responsible Physician, interfere with participation in this study according to its protocol.

Study & Design

• Study Type: Intervention
• Study Design: Not specified