Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT00353938 | Completed Phase 2 Results

• 1 other identifier: MP-2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD, MDMA, psychotherapy, Switzerland

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)

  The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Secondary Outcomes (1)

• Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)

  Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Study Arms (2)

Full Dose MDMA-assisted therapy (125 mg)

EXPERIMENTAL

Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA

Drug: 3,4-methylenedioxymethamphetamine (125 mg); Behavioral: Therapy

Active Placebo MDMA-assisted therapy (25 mg)

ACTIVE COMPARATOR

Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA

Drug: 3,4-methyelendioxymethamphetamine (25 mg); Behavioral: Therapy

Interventions

3,4-methylenedioxymethamphetamine (125 mg) DRUG

Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.

Also known as: MDMA

Full Dose MDMA-assisted therapy (125 mg)

3,4-methyelendioxymethamphetamine (25 mg) DRUG

Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.

Also known as: MDMA

Active Placebo MDMA-assisted therapy (25 mg)

Therapy BEHAVIORAL

Non-directive therapy performed by a team of two co-therapists

Active Placebo MDMA-assisted therapy (25 mg); Full Dose MDMA-assisted therapy (125 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with posttraumatic stress disorder (PTSD).
• PTSD still remains after one or more prior treatment, with treatment including psychotherapy (talk therapy) or drug therapy
• May meet criteria for a mood disorder
• Must be at least 18 years old
• Must be able to stop taking psychiatric medication during the course of the study, from the start of the study to the follow-up two months after experimental session 3.
• Must agree to follow all rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption.
• Must be willing to stay overnight at the researcher's office after each experimental session until the non-drug session occurring the next morning.
• Must be willing to be contacted by one of the researchers on a daily basis 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 have sufficient proficiency in speaking the German language to participate in MDMA-assisted psychotherapy. Participants must be able to read documents in German.

You may not qualify if:

• Cannot have history of or current primary psychotic disorder or bipolar affective disorder-1.
• Dissociative identity disorder, or an eating disorder with active purging or borderline personality disorder.
• Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
• Uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
• Being pregnant or lactating (nursing), or not practicing an effective method of birth control.
• Weight of less than 50 or more than 105 kg.
• Patients reporting prior use of "Ecstasy" 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 who need ongoing concomitant therapy with a psychotropic drug.
• Meeting DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
• People who cannot give adequate consent.

Sponsors & Collaborators

• Lykos Therapeutics: lead
• Swiss Medical Society for Psycholytic Therapy: collaborator

Study Sites (1)

Offices of Peter Oehen MD

Biberist, Canton of Solothurn, Switzerland

Location

Related Publications (4)

• Oehen P, Traber R, Widmer V, Schnyder U. A randomized, controlled pilot study of MDMA (+/- 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). J Psychopharmacol. 2013 Jan;27(1):40-52. doi: 10.1177/0269881112464827. Epub 2012 Oct 31.

  PMID: 23118021 RESULT

• Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.

  PMID: 32500209 DERIVED

• Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.

  PMID: 31572236 DERIVED

• Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7.

  PMID: 31065731 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Julie B. Wang, MPH, PhD/ Senior Clinical Data Scientist
• Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.

juliewang@mapsbcorp.com

(831) 429-6362

Study Officials

• Peter Oehen, MD

  private practice, Biberist, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 19, 2006
• Study Start: September 13, 2006
• Primary Completion: September 2, 2009
• Study Completion: January 10, 2011
• Last Updated: July 15, 2024
• Results First Posted: September 16, 2021

Record last verified: 2024-07

Locations

CH (1)