No registrations found.
ID
Source
Health condition
mdma users, cognition, 5HT
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurocognitive measures of memory and impulse control.
Secondary outcome
N/A
Background summary
N/A
Study objective
To determine the role of 5-HT2 and 5-HT1A receptors in learning and memory. It is expected that:
1. An acute dose of MDMA will produce impairments on laboratory measures of learning and memory;
2. MDMA-induced memory impairment will be reversed by coadministration of ketanserin if impairment is related to direct or indirect stimulation of 5-HT2 receptors;
3. MDMA-induced memory impairment will be reversed by coadministration of pindolol if impairment is related to direct or indirect stimulation of 5-HT1A receptors.
Study design
Neurocognitive measures will be taken at Tmax.
Intervention
Subjects will be treated with combinations of:
1. Ketanserin 50mg / MDMA 75mg (treatment 1);
2. Pindolol 20mg / MDMA 75mg (treatment 2);
3. Placebo / MDMA 75mg (treatment 3);
4. Pindolol 20 mg / placebo (treatment 4);
5. Ketaserin 50mg / placebo (treatment 5);
6. Placebo / placebo (treatment 6).
Drugs and placebo will be administered orally in identically appearing formulations. MDMA is administered as a 25 ml solution in bitter orange peel syrup, which is ingested at once. Ketanserin and pindolol will appear in capsule form. Drugs and placebo will be administered using a double dummy technique to synchronize Tmax for all drugs.
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Inclusion criteria
1. Between 18 and 40 years of age;
2. Experience with the use of MDMA (at least 5 times, of which no less than one in the past 12 months);
3. Free from psychotropic medication;
4. Good physical health as determined by examination and laboratory analysis;
5. Absence of any major medical, endocrine and neurological condition;
6. Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2;
7. Health insurance;
8. Written informed consent.
Exclusion criteria
1. History of drug abuse (other than the use of MDMA) or addiction;
2. Pregnancy or lactation;
3. Cardiovascular abnormalities as assessed by standard 12-lead ECG;
4. Excessive drinking (> 20 standard alcoholic consumptions a week);
5. Smoking (>10 sigarettes a day);
6. Hypertension (diastolic> 100; systolic> 170);
7. Use of psychotropic medication;
8. History of psychiatric or neurological disorder.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2227 |
| NTR-old | NTR2352 |
| Other | : P34 EPU |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |