Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-1)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on mood and psychological experience in people trained to practice MDMA-assistant psychotherapy in a therapy-like setting. Study participants will prepare for the experience with the investigators. After preparation, they will have two day-long sessions, one with placebo and one with MDMA, with the second session happening two days after the first. Order of session will be assigned randomly and the study will be double-blind. Subjects will complete measures and talk about the experience on the day after each session. Mood, psychological symptoms, and interpersonal closeness will be measured before and after each session. The investigators will speak with subjects again one and two months after the second experimental session, and subjects will complete a personality questionnaire two months after the second experimental session.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychological Effects of Study Drug |
Drug: Lactose (inactive placebo) Drug: 3,4-methylenedioxymethamphetamine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers |
- Profile of Mood States (POMS) [ Time Frame: Experimental session approximately six hours after drug administration ] [ Designated as safety issue: No ]Assesses current mood state
- Profile of Mood States (POMS) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: No ]Assesses current mood state
- Profile of Mood States (POMS) [ Time Frame: Day after each experimental session ] [ Designated as safety issue: No ]Assesses current mood state
- Interpersonal closeness measure [ Time Frame: Day prior to experimental session ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Visual analog scale assessing emotional closeness to self and four other targets
- Interpersonal closeness measure [ Time Frame: Day after each experimental session ] [ Designated as safety issue: No ]Visual analog scale assessing emotional closeness to self and four other targets
- Brief Symptom Inventory (BSI) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: Yes ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session prior to drug administraiton ] [ Designated as safety issue: Yes ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session approximately five to six hours after drug administraiton ] [ Designated as safety issue: Yes ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day after each experimental session ] [ Designated as safety issue: Yes ]Self-report measure assessing psychiatric symptoms
- Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: Yes ]Clinician-administered measure of suicide risk
- Neuroticism Extroversion Openness Personality Inventory [ Time Frame: At baseline ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: One month after the second experimental session ] [ Designated as safety issue: Yes ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Two months after the second experimental session ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session prior to drug administration ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Periodic assessment of participant pulse during both experimental sessions.
- Body temperature [ Time Frame: Approximately every 60 minutes for each experimental session ] [ Designated as safety issue: Yes ]Periodic assessment of participant body temperature during both experimental sessions.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Participant receives inactive placebo during day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.
|
Drug: Lactose (inactive placebo)
Placebo in an equivalent weight to MDMA will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist.
|
|
Active Comparator: MDMA
Participant receives 125 mg MDMA possibly followed by 62.5 mg MDMA during a day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.
|
Drug: 3,4-methylenedioxymethamphetamine
125 mg MDMA will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 62.5 mg may be administered 1.5 to 2.5 hours later.
|
Detailed Description:
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 twenty 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 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- have successfully completed a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research;
- are at least 21 years old;
- Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session.
- are willing to remain overnight at the study site;
- agree to have transportation other than driving themselves after the integrative session on the day after each experimental session;
- are willing to be contacted via telephone for all necessary telephone contacts;
- if a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control;
- are proficient in speaking and reading English;
- agree to have all clinic visit sessions recorded to audio and video
Exclusion Criteria:
- are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
- history of or current primary psychotic disorder, bipolar affective disorder type 1 or, dissociative identity disorder
- current psychiatric diagnosis other than adjustment disorder.
- have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration;
- have hypertension using standard criteria;
- have a history of hyponatremia or hyperthermia;
- weigh less than 48 kg;
- have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session;
- require ongoing therapy with a psychotropic drug;
- Substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days;
- unable to give adequate informed consent;
- have any current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with participation in the protocol.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01404754
| United States, South Carolina | |
| Offices of Michael Mithoefer | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Principal Investigator: | Michael M Mithoefer, MD | Private practice |
More Information
No publications provided
| Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
| ClinicalTrials.gov Identifier: | NCT01404754 History of Changes |
| Other Study ID Numbers: | MT-1 |
| Study First Received: | July 19, 2011 |
| Last Updated: | September 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Multidisciplinary Association for Psychedelic Studies:
|
MDMA mood subjective effects interpersonal closeness |
Additional relevant MeSH terms:
|
N-Methyl-3,4-methylenedioxyamphetamine Adrenergic Agents Adrenergic Uptake Inhibitors Central Nervous System Agents Hallucinogens Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents |
Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015