Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK)
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|ClinicalTrials.gov Identifier: NCT00886886|
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : January 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mood Disorder Substance-related Disorders Amphetamine-related Disorders||Drug: MDMA Drug: Reboxetine, 8 mg Drug: Placebo||Phase 1|
The study will use a randomized double-blind cross-over design with four experimental sessions. Reboxetine (8 mg) or placebo will be administered the night before the experimental session and 1 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective and cardiovascular responses and plasma samples for pharmacokinetics will be repeatedly assessed throughout the experiments.
We hypothesize that the highly selective norepinephrine uptake inhibitor reboxetine will attenuate subjective and especially heart rate and blood pressure responses to MDMA. Such a result would indicate that norepinephrine is critically involved in the pharmacology of MDMA and may provide helpful in the use and development of treatments for Ecstasy intoxications.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Pharmacological Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy): Pharmacological Effects and Pharmacokinetics|
|Study Start Date :||April 2009|
|Primary Completion Date :||December 2009|
|Study Completion Date :||March 2010|
Reboxetine, MDMA, Placebo
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.
125 mg, single doseDrug: Reboxetine, 8 mg
two doses 12h and 2h before MDMADrug: Placebo
capsules identical to MDMA or Reboxetine
- Effect of reboxetine on subjective responses to MDMA [ Time Frame: 24h ]
- Effect of reboxetine on physiological responses to MDMA [ Time Frame: 24h ]
- Effects of reboxetine on pharmacokinetics of MDMA [ Time Frame: 24h ]
- Tolerability of MDMA and reboxetine [ Time Frame: 7 days ]
- Effect of reboxetine on neuroendocrine responses to MDMA [ Time Frame: 24h ]
- Genetic polymorphisms [ Time Frame: assessed after study completion ]Effects of genetic polymorphisms on the response to MDMA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886886
|Principal Investigator:||Matthias E Liechti, MD||Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland|