MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title:

Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090064
• Other study ID #: MP1
• Status: Completed
• Phase: Phase 2
• Start date: March 12, 2004
• Est. completion date: June 21, 2010

Study information

• Verified date: February 2024
• Source: Lykos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy?

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 psychotherapy sessions and non-drug integrative sessions.

The study will test whether MDMA-assisted therapy can be safely given to participants. 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.

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.

MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted therapy may benefit people with PTSD.

This randomized, double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. Participants were assigned to receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions.

During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo with therapy during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second experimental session in Stage 1 and four to six weeks after the second MDMA-assisted therapy session in Stage 2. A final data-collection session took place at two months after the third experimental session.

The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving MDMA-assisted therapy versus placebo with therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 21, 2010
• Est. primary completion date: May 2, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;

• Have a CAPS score showing moderate to severe PTSD symptoms;

• They must either:

1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;

2. Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years

• Be at least 18 years old;

• Must be generally healthy;

• Willing to remain overnight at the study site;

• Agree to have transportation home the morning 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 reading English;

Exclusion Criteria:

• Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;

• Weigh less than 50 kg or more than 105 kg;

• Are unable to give adequate informed consent;

• Have a history of certain excluded medical disorders.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Midomafetamine
125 mg followed by a supplemental half-dose of 62.5 mg
• Lactose placebo pill
125 mg followed by a supplemental half-dose of 62.5 mg

Behavioral:
• Therapy
Non-directive therapy provided by a team of two co-therapists

Locations

Country	Name	City	State
United States	Offices of Michael Mithoefer MD	Mount Pleasant	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lykos Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Doblin R. The safety and efficacy of +/-3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled — View Citation

Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Martin SF, Yazar-Klosinski B, Michel Y, Brewerton TD, Doblin R. Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenediox — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 second experimental session
Secondary	Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up	The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.	Baseline to 2 months post second experimental session

External Links

•   View more information about MAPS' research into use of MDMA-assisted psychotherapy in people with PTSD