Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00990067
• Date of registration: 05/10/2009
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)
• Scientific title: Pharmacological Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy): Pharmacodynamics (PD) and Pharmacokinetics (PK)
• Date of first enrolment: November 2009
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00990067
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Countries of recruitment

Switzerland

Contacts

• Name: Matthias E Liechti, MD
• Affiliation: Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland

Key inclusion & exclusion criteria

Inclusion Criteria:

- Sufficient 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 refrain from taking illicit psychoactive substances
during the study.

- Participants must be willing to drink only alcohol-free liquids and no
xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate)
after midnight of the evening before the study session. Subjects must agree not to
smoke tobacco for 1 h before and 4 hours after MDMA administration.

- Participants must be willing not to drive a traffic vehicle in the evening of the
study day.

- 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: 18-25 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).
Personal or first-grade history of seizures. Cardiac or neurological disorder.

- Current or previous psychotic or affective disorder

- Psychotic or affective disorder in first-degree relatives

- Prior illicit drug use (except THC (Tetrahydrocannabinol)-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.)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amphetamine-Related Disorders

Mood Disorder

Substance-Related Disorders

Intervention(s)

Drug: 3,4-Methylenedioxymethamphetamine

Drug: Duloxetine

Drug: Placebo

Primary Outcome(s)

Effect of duloxetine on the subjective response to MDMA [Time Frame: 24h]

Secondary Outcome(s)

Effect of duloxetine on cardiovascular effects of MDMA [Time Frame: 6h]

Effect of duloxetine on neuroendocrine responses to MDMA [Time Frame: 6h]

Effect of duloxetine on pharmacokinetics of MDMA [Time Frame: 6h]

Effect of MDMA on duloxetine pharmacokinetics [Time Frame: 6h]

Tolerability of MDMA and duloxetine [Time Frame: 7 days]

Secondary ID(s)

EKBB 253/09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors