Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-1)

• Profile of Mood States (POMS) [ Time Frame: Experimental session approximately six hours after drug administration ]
  Assesses current mood state
  
  
• Profile of Mood States (POMS) [ Time Frame: Day prior to each experimental session ]
  Assesses current mood state
  
  
• Profile of Mood States (POMS) [ Time Frame: Day after each experimental session ]
  Assesses current mood state
  
  

• Interpersonal closeness measure [ Time Frame: Day prior to experimental session ]
  Visual analog scale assessing emotional closeness to self and four other targets
  
  
• Interpersonal closeness measure [ Time Frame: Day of experimental session approximately six hours post-drug administration ]
  Visual analog scale assessing emotional closeness to self and four other targets
  
  
• Interpersonal closeness measure [ Time Frame: Day after each experimental session ]
  Visual analog scale assessing emotional closeness to self and four other targets
  
  
• Brief Symptom Inventory (BSI) [ Time Frame: Day prior to each experimental session ]
  Self-report measure assessing psychiatric symptoms
  
  
• Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session prior to drug administration ]
  Self-report measure assessing psychiatric symptoms
  
  
• Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session approximately five to six hours after drug administration ]
  Self-report measure assessing psychiatric symptoms
  
  
• Brief Symptom Inventory (BSI) [ Time Frame: Day after each experimental session ]
  Self-report measure assessing psychiatric symptoms
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day prior to each experimental session ]
  Clinician-administered measure of suicide risk
  
  
• Neuroticism Extroversion Openness Personality Inventory [ Time Frame: At baseline ]
  Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
  
  
• Neuroticism Extroversion Openness Personality Inventory [ Time Frame: Two months after the second experimental session ]
  Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day after each experimental session ]
  Clinician-administered measure of suicide risk
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: One month after the second experimental session ]
  Clinician-administered measure of suicide risk
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Two months after the second experimental session ]
  Clinician-administered measure of suicide risk
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day six and 12 of telephone contact after second experimental session ]
  Clinician-administered measure of suicide risk
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session prior to drug administration ]
  Clinician-administered measure of suicide risk
  
  
• Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session approximately five to six hours after drug administration ]
  Clinician-administered measure of suicide risk
  
  
• Blood pressure (SBP/DBP) [ Time Frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours ]
  Periodic assessment of participant blood pressure during both experimental sessions.
  
  
• Heart rate (pulse) [ Time Frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours ]
  Periodic assessment of participant pulse during both experimental sessions.
  
  
• Body temperature [ Time Frame: Approximately every 60 minutes for each experimental session ]
  Periodic assessment of participant body temperature during both experimental sessions.
  
  

3,4-methylenedioxymethamphetamine (MDMA) produces changes in feelings and thoughts. It appears to have a unique pharmacological profile distinct from psychostimulants and classical hallucinogenic (psychedelic) compounds. Its unique properties have led to interest in using it in combination with psychotherapy. So far, studies in healthy volunteers have examined the effects of MDMA in a laboratory setting rather than a psychotherapeutic setting.

This study is a Phase 1 study for up to a hundred people, The information gathered during this study may help us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.

The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.