Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

NCT01458327 | Completed Phase 2 Results

• 1 other identifier: MP1-E2
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.

Conditions

Posttraumatic Stress Disorder

Keywords

MDMA; PTSD; therapy

Outcome Measures

Primary Outcomes (5)

• Baseline 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

• Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up

  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.

  2 months post experimental session

• Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up

  The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  12 months post experimental session

• Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up

  The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline to 2 months post experimental session

• Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up

  The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline to 12 months post experimental session

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

One experimental session of MDMA-assisted therapy

Drug: Midomafetamine; Behavioral: Therapy

Interventions

Midomafetamine DRUG

125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later

Also known as: MDMA, 3,4-methylenedioxymethamphetamine

MDMA-assisted therapy

Therapy BEHAVIORAL

Non-directive therapy

MDMA-assisted therapy

Eligibility Criteria

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

You may qualify if:

• Be diagnosed with chronic PTSD;
• Have a CAPS score showing moderate to severe PTSD symptoms;
• Have participated in MP-1;
• Are at least 18 years old;
• Must be generally healthy;
• Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
• Are willing to refrain from taking any psychiatric medications during the study period;
• Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
• Willing to remain overnight at the study site;
• Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
• 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;
• must provide a contact in the event of a participant becoming suicidal;
• Are proficient in speaking and reading English;
• agree to have all clinic visit sessions recorded to audio and video

You may not qualify if:

• Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
• Weigh less than 48 kg;
• Are abusing illegal drugs;
• Are unable to give adequate informed consent;
• 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.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Offices of Michael Mithoefer

Mt. Pleasant, South Carolina, 29464, United States

Location

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: Berra Yazar-Klosinski, PhD / Chief Scientific Officer
• Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.

trialdata@mapsbcorp.com

(831) 429-6362

Study Officials

• Michael C Mithoefer, MD

  Psychiatrist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 24, 2011
• Study Start: December 15, 2010
• Primary Completion: June 27, 2014
• Study Completion: June 27, 2014
• Last Updated: January 24, 2024
• Results First Posted: November 3, 2021

Record last verified: 2024-01

Locations

US (1)