Influence of Bupropion on the Effects of MDMA

NCT01771874 | Completed Phase 1 DMC

• 1 other identifier: EK 190/12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The study will provide further understanding of the dopaminergic regulation of mood.

Conditions

Healthy; Substance-related Disorders

Keywords

MDMA; pharmacokinetics; pharmacodynamics; emotions; Mechanism of action of MDMA; Interaction study; Effect of MDMA and bupropion on emotions

Outcome Measures

Primary Outcomes (1)

• Positive Mood Effects

  A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion.

  24 hours

Secondary Outcomes (7)

• Blood pressure(mmHg)during 10 hours

  10 hours

• Neuroendocrine plasma levels

  10 hours

• Drug plasma levels

  24 hours

• Heart rate (bpm)

  10 hours

• Body temperature

  10 hours

Study Arms (1)

MDMA, bupropion, placebo

EXPERIMENTAL

Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. The four treatment conditions are placebo-placebo, bupropion-placebo, placebo-MDMA, and bupropion-MDMA.

Drug: MDMA; Drug: Bupropion; Drug: Placebo

Interventions

MDMA DRUG

125 mg per os, single dose

Also known as: Ecstasy, 3,4-Methylenedioxymethamphetamine

MDMA, bupropion, placebo

Bupropion DRUG

Bupropion will be administered in a dose of 150mg (Wellbutrin XR) once-daily in the morning for three days followed by 300mg (2x150mg) for 4 days before the test day. On the test day, a final dose of 300mg will administered 2 hours before the administration of MDMA 125 mg or placebo.

Also known as: Wellbutrin XR, Zyban

MDMA, bupropion, placebo

Placebo DRUG

per os

Also known as: capsules containing manitol looking identical to MDMA or bupropion

MDMA, bupropion, placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45
• Understanding of the German language
• Subjects understand the procedures and the risks associated with the study
• Participants must be willing to adhere to the protocol and sign the consent form
• Participants must be willing to adhere to the protocol and sign the consent form
• Participants must be willing to drink only alcohol-free liquids and no xanthine-containing products(such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day
• Participants must be willing not to drive a traffic vehicle within 48 h following MDMA administration
• Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session
• Body mass index: 18-27 kg/m2

You may not qualify if:

• Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder
• Current or previous psychotic or major affective disorder
• Psychotic or major affective disorder in first-degree relatives
• Prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 5 times or any time within the previous 2 months
• Pregnant or nursing women
• Participation in another clinical trial (currently or within the last 30 days)
• Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
• Tobacco smoking

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4000, Switzerland

Location

Related Publications (2)

• Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.

  PMID: 29912955 DERIVED

• Boxler MI, Liechti ME, Schmid Y, Kraemer T, Steuer AE. First Time View on Human Metabolome Changes after a Single Intake of 3,4-Methylenedioxymethamphetamine in Healthy Placebo-Controlled Subjects. J Proteome Res. 2017 Sep 1;16(9):3310-3320. doi: 10.1021/acs.jproteome.7b00294. Epub 2017 Aug 9.

  PMID: 28722422 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Bupropion

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Propiophenones; Ketones

Study Officials

• Matthias E Liechti, MD, MAS

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

CH (1)