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Status:

COMPLETED

Neurobiology and Pharmacokinets of Acute MDMA Administration

Lead Sponsor:

National Institute on Drug Abuse (NIDA)

Conditions:

Substance-Related Disorders

Eligibility:

All Genders

18-40 years

Phase:

PHASE1

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 re...

Detailed Description

Background: 3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic compound that has shown a steep increase in abuse by young people in recent years. In animals, when high...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA: Participants must:
  • Be between the ages of 18 and 40.
  • 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.
  • 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.
  • Be without current clinically significant medical problems that would preclude safe study participation.
  • 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.
  • Have an 8th grade reading and comprehension level.
  • Additional requirements for participants undergoing neurocognitive testing:
  • Have an IQ ? 85 determined by the Wechsler Abbreviated Scale of Intelligence (WASI) (The Psychological Corporation, 1999).
  • Be right handed (Edinburgh Handedness Inventory (147)).
  • Speak English as their first language.
  • EXCLUSION CRITERIA: Participants must NOT:
  • 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.
  • 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.
  • 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.
  • If MDMA user, have hemoglobin levels less than 12.5-g/100 mL if male and less than 12-g/100 mL if female.
  • If MDMA user, have clinically significant abnormal resting 12-lead ECG.
  • If female, be pregnant or nursing.
  • Have liver function tests greater than 3 times upper limit of normal range.
  • Be unable to comply with task demands.
  • 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.
  • If non-drug using control, have a hair test positive for non-therapeutic psychoactive drugs.
  • If drug using control, have hair test results that are inconsistent with self-reported drug use.
  • Additional exclusion criteria for participants undergoing neurocognitive testing:
  • \<TAB\>Have head trauma with loss of consciousness for greater than 3 minutes
  • \<TAB\>Have a positive HIV serology test (retested after six months).
  • \<TAB\>Have an ADHD Screening Rating Scale score greater than or equal to 24 on either the A or B subscale.
  • \<TAB\>Have a positive Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) confirmatory test for syphilis.

Exclusion

    Key Trial Info

    Start Date :

    February 10 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 18 2012

    Estimated Enrollment :

    187 Patients enrolled

    Trial Details

    Trial ID

    NCT01148342

    Start Date

    February 10 2004

    End Date

    July 18 2012

    Last Update

    December 12 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institute on Drug Abuse, Biomedical Research Center (BRC)

    Baltimore, Maryland, United States, 21224