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Influence of Bupropion on the Effects of MDMA

Primary Purpose

Healthy, Substance-related Disorders

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
MDMA
Bupropion
Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring MDMA, pharmacokinetics, pharmacodynamics, emotions, Mechanism of action of MDMA, Interaction study, Effect of MDMA and bupropion on emotions

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDMA, bupropion, placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood pressure(mmHg)during 10 hours
Neuroendocrine plasma levels
assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
Drug plasma levels
The plasma concentration of MDMA and bupropion is repetitively assessed
Heart rate (bpm)
Body temperature
Effects on social cognition (emotion recognition and empathy)
Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA
We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations.

Full Information

First Posted
October 24, 2012
Last Updated
January 20, 2016
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01771874
Brief Title
Influence of Bupropion on the Effects of MDMA
Official Title
Influence of Bupropion on the Effects of MDMA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE). 5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is involved in the cardiovascular and psychostimulant effects of MDMA. DA mediates the reinforcing addiction-related effects of drugs of abuse but it is unclear whether DA contributes to the acute effects of MDMA in humans. To determine the role of DA transporter-mediated DA release in the acute response to MDMA in humans the investigators test the effects of the DA transporter inhibitor bupropion on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Bupropion or placebo will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that bupropion reduces the MDMA-induced increase in positive mood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Substance-related Disorders
Keywords
MDMA, pharmacokinetics, pharmacodynamics, emotions, Mechanism of action of MDMA, Interaction study, Effect of MDMA and bupropion on emotions

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDMA, bupropion, placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MDMA
Other Intervention Name(s)
Ecstasy, 3,4-Methylenedioxymethamphetamine
Intervention Description
125 mg per os, single dose
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin XR, Zyban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
capsules containing manitol looking identical to MDMA or bupropion
Intervention Description
per os
Primary Outcome Measure Information:
Title
Positive Mood Effects
Description
A significant reduction of the (100-mm Visual Analog Scale) positive mood response to MDMA by bupropion.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Blood pressure(mmHg)during 10 hours
Time Frame
10 hours
Title
Neuroendocrine plasma levels
Description
assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone
Time Frame
10 hours
Title
Drug plasma levels
Description
The plasma concentration of MDMA and bupropion is repetitively assessed
Time Frame
24 hours
Title
Heart rate (bpm)
Time Frame
10 hours
Title
Body temperature
Time Frame
10 hours
Title
Effects on social cognition (emotion recognition and empathy)
Time Frame
10 hours
Title
Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA
Description
We will assess the effects of the subjects' genotype and phenotype on MDMA and its metabolites plasma concentrations.
Time Frame
24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias E Liechti, MD, MAS
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4000
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29912955
Citation
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.
Results Reference
derived
PubMed Identifier
28722422
Citation
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.
Results Reference
derived

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Influence of Bupropion on the Effects of MDMA

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