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Neurobiology and Pharmacokinets of Acute MDMA Administration

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ClinicalTrials.gov Identifier: NCT01148342
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : December 12, 2019
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

  • 3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic psychoactive drug that has shown a steep increase in recreational use and abuse by young people in recent years. Research studies have reported that chronic MDMA users who also consume other legal and illegal substance show memory deficits; however, because of the combination of drugs often involved, it is difficult to determine MDMA s contribution to these effects.
  • Only a few studies have examined the immediate physical and behavioral effects of MDMA given at dose levels commonly used in young adults. Researchers are interested in using functional magnetic resonance imaging (fMRI) to examine changes in brain activity and function in MDMA users compared with users of other drugs and non-drug-using individuals.

Objectives:

- To evaluate the effects of MDMA on thinking and brain function.

Eligibility:

- Individuals between 18 and 30 years of age who are (1) current users of MDMA (2), current drug users who do not use MDMA, or (3) healthy non-drug-using volunteers.

Design:

  • Participants will complete one training session and three scanning sessions.
  • Before the start of the study, participants will complete questionnaires about medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed during the scanning session(s), and will allow participants to practice the tests.
  • Participants will provide urine, saliva, and hair samples for testing before the start of the study, and multiple times during each scanning session.
  • Participants who use MDMA and participants who use other drugs will stay overnight at the clinical center prior to each scanning session. Participants who do not use drugs can spend the night prior to scanning or arrive at the clinical center on the morning of the scanning session.
  • Participants who use MDMA will receive either MDMA or a placebo during the scanning sessions, and will not be told which one they have received. Because of the nature of MDMA, participants will be required to stay at the clinical center until the effects of the drug have worn off, and will be required to return to the clinical center on the following day for a follow-up examination.
  • During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks will be performed on a computer in an MRI machine, and may involve receiving monetary rewards for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: MDMA Drug: (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Other
Official Title: Neurobiology and Pharmacokinetics of Acute MDMA Administration
Study Start Date : February 10, 2004
Actual Study Completion Date : July 18, 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: MDMA
  • Drug: (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules
    0, 1.0 & 1.6 mg/kg


Primary Outcome Measures :
  1. MDMA effects on human brain function and relationship between plasma MDMA concentrations and human brain function.

Secondary Outcome Measures :
  1. MDMA pharmacokinetics in various biological matrices.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA: Participants must:

    1. Be between the ages of 18 and 40.
    2. If MDMA group, have consumed at least five tablets of ecstasy in their lifetime with no clinically significant adverse medical or psychiatric reactions from using the drug or other stimulants and must have used at least once within the past 30 days (Drug Use Survey), with no current intention to stop MDMA use. History of ecstasy consumption is supported by a minimum of one positive urine amphetamines or hair MDMA drug test within the past 90 days. Urine drug tests at scanning visits must not be positive for drugs, other than amphetamines and cannabis. Scanning visits can be rescheduled once due to a positive urine test for other drugs.
    3. If control group, have no history of MDMA use (Drug Use Survey) and have negative urine test for amphetamines. If in the non-drug using group, must have a negative urine test for non-therapeutic psychoactive drugs at screening and scanning visits. Lifetime cannabis use for these participants cannot exceed ten times, with no use in the past two years (Timeline Follow-Back Method (146)). At screening, drug using controls may test positive for other drugs, other than amphetamines. At scanning, drug using controls may be positive for cannabis only. Scanning visits can be rescheduled once due to a positive urine test for other drugs.
    4. Be without current clinically significant medical problems that would preclude safe study participation.
    5. If female, must use a reliable method of birth control or abstain from sexual intercourse. Female participants will be counseled that a urine pregnancy test cannot detect pregnancies within 7 to 14 days of conception.
    6. Have an 8th grade reading and comprehension level.

      Additional requirements for participants undergoing neurocognitive testing:

    7. Have an IQ ? 85 determined by the Wechsler Abbreviated Scale of Intelligence (WASI) (The Psychological Corporation, 1999).
    8. Be right handed (Edinburgh Handedness Inventory (147)).
    9. Speak English as their first language.

EXCLUSION CRITERIA: Participants must NOT:

  1. Have known major medical or axis I psychiatric diagnosis other than substance abuse (Structured Clinical Interview (SCID) for the Diagnostic & Statistical Manual of Mental Disorders IV (DSM-IV) criteria). Participants with a history of psychotropic medicine use will be evaluated by the MRP on a case-by-case basis to uncover the precise diagnosis for the use of the drug. Individuals who have substance dependence other than nicotine or cannabis, based on DSM IV criteria, will be excluded from the study. Prospective participants will be excluded if they smoke more than two packs of cigarettes per day.
  2. If MDMA user, be currently using (within 30 days of MDMA administration) one of the following inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4:

    CYP2D6 inhibiting drugs<TAB><TAB><TAB><TAB>

    Antidepressants: paroxetine, fluoxetine, sertraline, fluvoxamine, nefazodone, venlafaxine, clomipramine, amitriptyline, citalopram, bupropion

    Antipsychotics: haloperidol, perphenazine, thioridazine, levomepromazine, pimozide, fluphenazine

    Antiarrythmics: quinidine

    Protease inhibitors: ritonavir

    CYP3A4 inhibiting drugs

    Antidepressants: nefazodone, fluvoxamine, fluoxetine, sertraline, paroxetine, venlafaxine, norfluoxetine

    Azole antifungals: ketoconazole, itraconazole, fluconazole

    Protease inhibitors: ritonavir, nelfinavir, amprenavir

    Nonnucleoside reverse transcriptase inhibitors: efavirenz, delavirdine

    Histamine H2 -receptor antagonists: cimetidine

    Macrolide antibiotics: clarithromycin, erythromycin

    Calcium channel blockers: diltiazem

    In addition, participants will be advised to limit their consumption of grapefruit juice.

    CYP3A4 inducing drugs

    Antibacterials: rifampin

    Antidepressants: St. John s wart

    Anticonvulsants: carbamazepine, phenobarbital, phenytoin

    Adrenocortical steroids: dexamethasone

    If potential participants need to continue taking these drugs as part of a physician prescribed treatment regimen, they will be excluded for safety purposes. Potential participants will be advised that there should be a minimum 30-day abstention from the use of these listed compounds prior to MDMA administration.

  3. If MDMA user, SBP greater than 135 and DBP greater than 85 taken after at least 5 minutes rest, tachycardic (resting HR greater than 100 bpm), or hypercholesterolemic (total cholesterol greater than 250 mg/dL) if above the age of 30.
  4. If MDMA user, have hemoglobin levels less than 12.5-g/100 mL if male and less than 12-g/100 mL if female.
  5. If MDMA user, have clinically significant abnormal resting 12-lead ECG.
  6. If female, be pregnant or nursing.
  7. Have liver function tests greater than 3 times upper limit of normal range.
  8. Be unable to comply with task demands.
  9. Have a history of neurological illnesses including but not limited to stroke, central nervous system tumor, encephalitis or other CNS infection, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders, or migraine headaches severe enough to require treatment.
  10. If non-drug using control, have a hair test positive for non-therapeutic psychoactive drugs.
  11. If drug using control, have hair test results that are inconsistent with self-reported drug use.

    Additional exclusion criteria for participants undergoing neurocognitive testing:

  12. <TAB>Have head trauma with loss of consciousness for greater than 3 minutes
  13. <TAB>Have a positive HIV serology test (retested after six months).
  14. <TAB>Have an ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale.
  15. <TAB>Have a positive Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) confirmatory test for syphilis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148342


Locations
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United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Marilyn Huestis, Ph.D. National Institute on Drug Abuse (NIDA)
Publications:
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ClinicalTrials.gov Identifier: NCT01148342    
Other Study ID Numbers: 999904394
04-DA-N394
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: July 18, 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
Ecstacy
fMRI
Alternative Matrices
Cognitive Training
Brain Imaging
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents