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The role of stress in relapse of drug addiction


- candidate number21779
- NTR NumberNTR5021
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2015
- Secondary IDsEK 019/15 2012-005284-27
- Public TitleThe role of stress in relapse of drug addiction
- Scientific TitleStressing the brain's pleasure circuit: stress hormones, dopamine and addiction
- ACRONYMShAdDo
- hypothesis1. Methylphenidate (MPH) increases activation in task relevant areas and task performance
2. Hydrocortisone (HC) increases activation in task relevant areas and task performance
3. MPH + HC increase activation in task relevant areas, but might impair task performance in healthy controls and improve in recreational drug users
- Healt Condition(s) or Problem(s) studiedAddiction, Relapse, Stress
- Inclusion criteria-bloodscreen (normal level)
-thyroidal parameters (normal level)
-ECG (normal level)
-negative drugscreen in urine (Benzodiazepine, Opiate, Amphetamine, Cannabis).
-no nephrological or thyroidal diseases in medical history
-no metal in the human body
-no tattoos
-age between 18 and 40 years
-Body Mass Index (BMI) between 18 und 28
-no first degree relatives with psychiatric disorders in medical history
-no psychiatric or neurological disorders in medical history
-righthandedness
-native German speakers
For women: negative pregnancy test
For recreational drug users: experience with psychostimulants
- Exclusion criteria-volunteers who are unable to sign the informed consent
-pregnancy
-volunteers under the age of 18 years
-magnetic metal implants, contraceptive coil, tattoos
-colorblindness
For recreational drug users: drug addiction or dependence in medical
history
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-mrt-2015
- planned closingdate31-jul-2016
- Target number of participants32
- Interventions1.placebo
2. methylphenidate
3. hydrocortisone
4. methylphenidate + hydrocortisone
- Primary outcome-imaging results under the influence of a psychostimulant, a stress hormone or both.
- Secondary outcome-behavioural performance on cognitive tasks under the influence of a psychostimulant, a stress hormone or both.
- TimepointsDay 1, day 8, day 15, day 22
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Wendy Bosker
- CONTACT for SCIENTIFIC QUERIES Wendy Bosker
- Sponsor/Initiator Forschungszentrum Juelich
- Funding
(Source(s) of Monetary or Material Support)
Forschungszentrum Juelich , Alexander von Humboldt Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-mrt-2015 - 15-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl