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n-methyl-3,4-methylenedioxyamphetamine and Adverse Drug Event

n-methyl-3,4-methylenedioxyamphetamine has been researched along with Adverse Drug Event in 14 studies

N-Methyl-3,4-methylenedioxyamphetamine: An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy.
3,4-methylenedioxymethamphetamine : A member of the class of benzodioxoles that is 1,3-benzodioxole substituted by a 2-(methylamino)propyl group at position 5.

Research Excerpts

ExcerptRelevanceReference
"Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective."3.01MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. ( Amar, S; Amiaz, R; Bogenschutz, M; Brown, R; Carlin, S; Coker, A; de Boer, A; Doblin, R; Emerson, A; Garas, W; Gelfand, Y; Gorman, I; Hamilton, S; Hapke, E; Harrison, C; Klaire, SS; Kleiman, S; Lilienstein, A; Marta, C; Matthews, R; Mitchell, JM; Mithoefer, A; Mithoefer, M; Nicholas, C; Ot'alora G, M; Paleos, C; Parker-Guilbert, K; Poulter, B; Quevedo, S; Shannon, S; Tzarfaty, K; van der Kolk, B; Wallach, Y; Wang, JB; Wells, G; Woolley, JD; Worthy, R; Yazar-Klosinski, B, 2021)
" Many studies introduce statistical errors by inconsistently dichotomizing and comparing light and heavy ecstasy users, making dose-response relationships inconclusive."2.61The spurious relationship between ecstasy use and neurocognitive deficits: A Bradford Hill review. ( Amoroso, T, 2019)
"Besides smoking, alcohol abuse has also been implicated as a renal risk factor."2.41[Adverse renal effects of legal and illicit drugs]. ( Orth, SR, 2002)
" This review discusses both the short- and long-term effects of 3,4-methylenedioxy-methamphetamine including methods by which some of these adverse effects can be prevented or even reversed to increase the safety of the commonly used drug."1.48Is the recreational use of 3,4-methylenedioxy-methamphetamine safe? ( Boote, T, 2018)
"Increased risk of ventricular septal defect was found to be associated with consumption of cough and cold remedies [pre-conception OR 2."1.32A case control study to examine the pharmacological factors underlying ventricular septal defects in the North of England. ( Bateman, DN; Dickinson, D; Matthews, JN; McElhatton, PR; O'Keeffe, M; Thomas, SH; Wren, C, 2004)

Research

Studies (14)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's7 (50.00)29.6817
2010's4 (28.57)24.3611
2020's3 (21.43)2.80

Authors

AuthorsStudies
Palamar, JJ1
Cohen, IV1
Makunts, T1
Abagyan, R1
Thomas, K1
Mitchell, JM1
Bogenschutz, M1
Lilienstein, A1
Harrison, C1
Kleiman, S1
Parker-Guilbert, K1
Ot'alora G, M1
Garas, W1
Paleos, C1
Gorman, I1
Nicholas, C1
Mithoefer, M1
Carlin, S1
Poulter, B1
Mithoefer, A1
Quevedo, S1
Wells, G1
Klaire, SS1
van der Kolk, B1
Tzarfaty, K1
Amiaz, R1
Worthy, R1
Shannon, S1
Woolley, JD1
Marta, C1
Gelfand, Y1
Hapke, E1
Amar, S1
Wallach, Y1
Brown, R1
Hamilton, S1
Wang, JB1
Coker, A1
Matthews, R1
de Boer, A1
Yazar-Klosinski, B1
Emerson, A1
Doblin, R1
Boote, T1
Davies, N1
English, W1
Grundlingh, J1
Amoroso, T1
Wood, DM1
Greene, SL1
Dargan, PI1
Bateman, DN1
McElhatton, PR1
Dickinson, D1
Wren, C1
Matthews, JN1
O'Keeffe, M1
Thomas, SH1
Tanner-Smith, EE1
Nutt, DJ1
Parrott, AC1
Vollenweider, FX1
Jones, RT1
Baggott, MJ1
Yuan, J1
Cord, BJ1
McCann, UD1
Callahan, BT1
Ricaurte, GA1
Orth, SR1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
MDMA-Assisted Cognitive Behavioral Therapy (CBT) Compared With Methamphetamine-Assisted CBT in Obsessive-Compulsive Disorder (OCD): A Phase II Study[NCT05783817]Phase 240 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder[NCT03537014]Phase 3100 participants (Actual)Interventional2018-11-21Completed
A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD[NCT05790239]Phase 240 participants (Anticipated)Interventional2023-10-31Not yet recruiting
MDMA-Assisted Therapy 6 to 12 Months After Childbirth for People With Co-occurring Opioid Use and Post Traumatic Stress Disorders[NCT05219175]Phase 215 participants (Anticipated)Interventional2024-01-01Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)

The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. 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. (NCT03537014)
Timeframe: Baseline to 18 weeks post enrollment confirmation

Interventionscore on a scale (Mean)
MDMA-assisted Therapy-24.4
Placebo With Therapy-13.9

Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS) Total Score

The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment that was adapted for the purposes of this study to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment. The SDS is a 3-item scale measuring the severity of disability in the domains of work, family life/home responsibilities and social/leisure activities, with each item scored on a ten-point Likert scale from 0 ('not at all impaired') to 10 ('very severely impaired'). The SDS total score was the mean of the 3 item responses. The SDS total score ranged from 0 to 10, with higher scores indicating greater functional impairment. (NCT03537014)
Timeframe: Baseline to 18 weeks post enrollment confirmation

Interventionscore on a scale (Mean)
MDMA-assisted Therapy-3.1
Placebo With Therapy-2.0

Reviews

3 reviews available for n-methyl-3,4-methylenedioxyamphetamine and Adverse Drug Event

ArticleYear
MDMA toxicity: management of acute and life-threatening presentations.
    British journal of nursing (Mark Allen Publishing), 2018, Jun-14, Volume: 27, Issue:11

    Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Illicit Drugs; N-Methyl-3,4-methylenedioxya

2018
The spurious relationship between ecstasy use and neurocognitive deficits: A Bradford Hill review.
    The International journal on drug policy, 2019, Volume: 64

    Topics: Cognition; Databases, Bibliographic; Drug-Related Side Effects and Adverse Reactions; Humans; Memory

2019
[Adverse renal effects of legal and illicit drugs].
    Therapeutische Umschau. Revue therapeutique, 2002, Volume: 59, Issue:3

    Topics: Acute Kidney Injury; Adolescent; Adult; Alcoholism; Amphetamines; Anti-Anxiety Agents; Benzodiazepin

2002

Trials

1 trial available for n-methyl-3,4-methylenedioxyamphetamine and Adverse Drug Event

ArticleYear
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
    Nature medicine, 2021, Volume: 27, Issue:6

    Topics: Adult; Combined Modality Therapy; Double-Blind Method; Drug-Related Side Effects and Adverse Reactio

2021

Other Studies

10 other studies available for n-methyl-3,4-methylenedioxyamphetamine and Adverse Drug Event

ArticleYear
Adverse drug effects as a deterrent against willingness to use in the future among nightclub/festival attendees.
    Drug and alcohol review, 2023, Volume: 42, Issue:6

    Topics: Adult; Drug-Related Side Effects and Adverse Reactions; Holidays; Humans; Illicit Drugs; Ketamine; M

2023
Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database.
    Scientific reports, 2021, 03-16, Volume: 11, Issue:1

    Topics: Adverse Drug Reaction Reporting Systems; Antidepressive Agents; Cause of Death; Databases, Factual;

2021
Is the recreational use of 3,4-methylenedioxy-methamphetamine safe?
    The Medico-legal journal, 2018, Volume: 86, Issue:2

    Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Illicit Drugs; N-Methyl-3,4-methylenedioxya

2018
Five-year trends in self-reported recreational drugs associated with presentation to a UK emergency department with suspected drug-related toxicity.
    European journal of emergency medicine : official journal of the European Society for Emergency Medicine, 2013, Volume: 20, Issue:4

    Topics: Amphetamine-Related Disorders; Cocaine-Related Disorders; Drug-Related Side Effects and Adverse Reac

2013
A case control study to examine the pharmacological factors underlying ventricular septal defects in the North of England.
    European journal of clinical pharmacology, 2004, Volume: 60, Issue:9

    Topics: Adolescent; Adult; Amphetamines; Birth Weight; Case-Control Studies; Cohort Studies; Drug-Related Si

2004
Pharmacological content of tablets sold as "ecstasy": results from an online testing service.
    Drug and alcohol dependence, 2006, Jul-27, Volume: 83, Issue:3

    Topics: Drug Contamination; Drug-Related Side Effects and Adverse Reactions; Hallucinogens; Humans; Illicit

2006
A tale of two Es.
    Journal of psychopharmacology (Oxford, England), 2006, Volume: 20, Issue:3

    Topics: Alcoholic Intoxication; Amphetamine-Related Disorders; Cause of Death; Community Participation; Drug

2006
Drug-related harm: a complex and difficult concept to scale.
    Human psychopharmacology, 2007, Volume: 22, Issue:7

    Topics: Catha; Drug-Related Side Effects and Adverse Reactions; Hallucinogens; Harm Reduction; Humans; N-Met

2007
Caveat emptor: editors beware.
    Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2001, Volume: 24, Issue:4

    Topics: Animals; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug-Related Side Effects and A

2001
Effect of depleting vesicular and cytoplasmic dopamine on methylenedioxymethamphetamine neurotoxicity.
    Journal of neurochemistry, 2002, Volume: 80, Issue:6

    Topics: Adrenergic Uptake Inhibitors; alpha-Methyltyrosine; Animals; Corpus Striatum; Cytoplasm; Cytoplasmic

2002