NCT00895804

Brief Summary

MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
Last Updated

June 15, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

May 7, 2009

Last Update Submit

June 12, 2009

Conditions

Mood DisorderSubstance-Related DisordersAmphetamine-Related Disorders

Keywords

MDMAbeta adrenergicEcstasy

Outcome Measures

Primary Outcomes (1)

  • Effect of pindolol on subjective response to MDMA

    24h

Secondary Outcomes (1)

  • Effect of pindolol on physiological response to MDMA

    24h

Study Arms (2)

Pindolol, Placebo

OTHER

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.

Drug: MDMADrug: Pindolol

MDMA, Placebo

OTHER

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.

Drug: MDMADrug: Pindolol

Interventions

MDMADRUG

capsule, 1.6 mg/kg body weight, single dose

MDMA, PlaceboPindolol, Placebo
PindololDRUG

capsule of 20mg pindolol, single dose 1h before MDMA

MDMA, PlaceboPindolol, Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 after midnight of the evening before the study session.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • Body mass index: 18-25 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). 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-containing products) more than 5 times or any time within the previous 2 months.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heffter Research Center, University Hospital of Psychiatry

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Mood DisordersSubstance-Related DisordersAmphetamine-Related Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetaminePindolol

Condition Hierarchy (Ancestors)

Mental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanols

Study Officials

  • Matthias E Liechti, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

June 1, 2001

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

June 15, 2009

Record last verified: 2009-06

Locations

CH(1)