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HealthyPhase 1NCT01771874

Influence of Bupropion on the Effects of MDMA

A Phase 1 study testing MDMA and Bupropion in people with Healthy and Substance-related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Substance-related Disorders
What is being tested?
MDMA and Bupropion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteSwitzerland
Study dates
Jan 2013to Sep 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, Canton of Basel-City, 4000

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
MDMA, Bupropion, Placebo
Keywords
MDMA, pharmacokinetics, pharmacodynamics, emotions, Mechanism of action of MDMA, Interaction study, Effect of MDMA and bupropion on emotions
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDMADrug

    Also called Ecstasy, 3,4-Methylenedioxymethamphetamine

    125 mg per os, single dose

  • BupropionDrug

    Also called Wellbutrin XR, Zyban

    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.

  • PlaceboDrug

    Also called capsules containing manitol looking identical to MDMA or bupropion

    per os

Study groups in NCT01771874
Study groupRoleWhat they receive
MDMA, bupropion, placeboExperimentalCross-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.
Receives: Drug: MDMA; Drug: Bupropion; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive Mood Effects

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

    Measured: 24 hours

Secondary outcomes (7)

  1. Blood pressure(mmHg)during 10 hours

    Measured: 10 hours

  2. Neuroendocrine plasma levels

    assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogen,and progesterone

    Measured: 10 hours

  3. Drug plasma levels

    The plasma concentration of MDMA and bupropion is repetitively assessed

    Measured: 24 hours

  4. Heart rate (bpm)

    Measured: 10 hours

  5. Body temperature

    Measured: 10 hours

  6. Effects on social cognition (emotion recognition and empathy)

    Measured: 10 hours

  7. 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.

    Measured: 24hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01771874
Sponsor's protocol ID
EK 190/12
Status last verified
Jan 2016
First submitted
24 Oct 2012
Last updated
21 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29912955

  • 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.

    PubMed 28722422

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDMA and Bupropion in people with Healthy and Substance-related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Mood Effects (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01771874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.

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