Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

January 22, 2024 updated by: Lykos Therapeutics

A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms?

Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of 62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions.

Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period. Safety measures will also be assessed between groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs.

This randomized, double-blind, placebo-controlled clinical study will assess the safety and efficacy of MDMA-assisted therapy in treating chronic, treatment-resistant PTSD. In Stage 1, participants will be randomized to either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions, spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of 62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions. After this treatment period, participants will complete the primary endpoint assessment and the study will become unblinded.

Participants who were assigned to receive MDMA-assisted therapy will receive a third session of MDMA-assisted therapy that is open-label and participants assigned to receive placebo with therapy will have the option to enter Stage 2. Stage 2 will explore the optimal therapeutic dose of MDMA in a clinical titration dosing strategy. Participants will receive MDMA-assisted with an initial dose of 100 mg followed by a dose of 50 mg of MDMA for the first experimental session. In the second and third experimental sessions, participants will have the option to increase the dose to an initial dose of 125 mg followed by a dose of 62.5 mg.

A blinded independent rater will assess PTSD symptoms via the CAPS-IV as well as other secondary outcome measures and safety measures.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6R 1N6
        • Offices of Dr. Ingrid Pacey MBBS FRCP[C]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo with therapy
Participants will receive placebo with therapy during each of two experimental sessions.
Drug: Placebo
Placebo with therapy administered in two blinded experimental sessions. Participants in this group in Stage 1 may take part in Stage 2.
Other Names:
  • Inactive placebo
Behavioral: Psychotherapy
Psychotherapy before and after experimental sessions.
Experimental: MDMA-assisted therapy
Participants will receive MDMA (initial dose of 125 mg followed by a supplemental dose of 62.5 mg) with therapy during each of two experimental sessions.
Behavioral: Psychotherapy
Psychotherapy before and after experimental sessions.
Drug: Midomafetamine
Participants will receive MDMA-assisted therapy during two blinded experimental sessions. After unblinding, may receive a third session of open-label MDMA-assisted therapy.
Other Names:
  • MDMA
  • 3,4-methylenedioxymethamphetamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician-Administered PTSD Scale (CAPS-IV) Score From Baseline to Primary Endpoint
Time Frame: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)
Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. The Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-4. It contains symptom subscales, a CAPS-4 total severity score, and a diagnostic score. 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 Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lykos Therapeutics

Investigators

  • Principal Investigator: Ingrid Pacey, MBBS FRCP[C], University of Victoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2014

Primary Completion (Actual)

September 10, 2015

Study Completion (Actual)

October 17, 2016

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimated)

October 9, 2013

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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