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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
3,4-methylenedioxymethamphetamine (125 mg)
3,4-methyelendioxymethamphetamine (25 mg)
Therapy
Sponsored by
Multidisciplinary Association for Psychedelic Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, MDMA, psychotherapy, Switzerland

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Offices of Peter Oehen MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full Dose MDMA-assisted therapy (125 mg)

Active Placebo MDMA-assisted therapy (25 mg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.

Full Information

First Posted
July 17, 2006
Last Updated
May 5, 2023
Sponsor
Multidisciplinary Association for Psychedelic Studies
Collaborators
Swiss Medical Association for Psycholytic Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT00353938
Brief Title
Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
Official Title
Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2006 (Actual)
Primary Completion Date
September 2, 2009 (Actual)
Study Completion Date
January 10, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Multidisciplinary Association for Psychedelic Studies
Collaborators
Swiss Medical Association for Psycholytic Therapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering. 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. People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, MDMA, psychotherapy, Switzerland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full Dose MDMA-assisted therapy (125 mg)
Arm Type
Experimental
Arm Description
Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA
Arm Title
Active Placebo MDMA-assisted therapy (25 mg)
Arm Type
Active Comparator
Arm Description
Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
Intervention Type
Drug
Intervention Name(s)
3,4-methylenedioxymethamphetamine (125 mg)
Other Intervention Name(s)
MDMA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
3,4-methyelendioxymethamphetamine (25 mg)
Other Intervention Name(s)
MDMA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapy
Intervention Description
Non-directive therapy performed by a team of two co-therapists
Primary Outcome Measure Information:
Title
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
Description
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.
Time Frame
Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)
Secondary Outcome Measure Information:
Title
Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
Description
The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.
Time Frame
Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Oehen, MD
Organizational Affiliation
private practice, Biberist, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Offices of Peter Oehen MD
City
Biberist
State/Province
Solothurn
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23118021
Citation
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.
Results Reference
result
PubMed Identifier
32500209
Citation
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.
Results Reference
derived
PubMed Identifier
31572236
Citation
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.
Results Reference
derived
PubMed Identifier
31065731
Citation
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.
Results Reference
derived

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

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