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The influence of cocaine and cannabis on impulsivity.


- candidate number6773
- NTR NumberNTR2127
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2009
- Secondary IDsNL29685.068.09 CCMO
- Public TitleThe influence of cocaine and cannabis on impulsivity.
- Scientific TitleCognitive and motor impulsivity in regular cannabis and cocaine users as a function of COMT and DBH genotype.
- ACRONYM
- hypothesisAcute challenges with cocaine and cannabis will induce two opposing dopaminergic states in the brain. Cocaine will stimulate dopamine release leading to hyperdopaminergia whereas cannabis will reduce central dopamine levels resulting in hypodopaminergia. Drug induced impulsive behaviours can occur during both dopaminergic states depending on COMT and DBH genotypes and type of drug.
- Healt Condition(s) or Problem(s) studiedCannabis, Cocaine, Impulsivity, Genotyping
- Inclusion criteria1. Regular use of cannabis and cocaine;
2. Good physical and mental health;
3. Body weight between 80 and 130% of the ideal bodyweight as defined in the Metropolitan Life Insurance tables;
4. Age 18-40.
- Exclusion criteria1. Pregnancy or lactation;
2. Cardiovascular abnormalities as assessed by standard ECG;
3. Excessive drinking;
4. Hypertension;
5. History of psychiatric and neurological disorders.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants60
- Interventions1. Cocaine HCl 300mg as capsule;
2. Cannabis 20mg by inhalation;
3. Placebo.
- Primary outcomeThe influence of cocaine and cannabis on impulsivity modulated by COMT and DBH genotypes. Genotyping of DBH will be performed before inclusion, COMT after testing.
- Secondary outcomeOutcomes on:
1. Matching familiar figures;
2. Stop-signal task;
3. Tower of London;
4. CTT/DAT;
5. Attentional Switch task;
6. Prospective memory task;
7. Cued Go/NoGo task.
- TimepointsTimepoint: 1 day.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Wel, van
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryGenetic variations may affect drug induced changes in impulsivity and vulnerability to drug abuse. Two prime genes linking loss of impulse control, prefrontal dopamine (DA) and drug addiction are catechol O-methyltransferase (COMT) and dopamine beta-hydroxylase (DBH). Yet, the precise role of genetic variations on prefrontal DA and vulnerability to drug abuse is largely unknown. The current research proposal is designed to assess the influence of cocaine and cannabis on impulse control and to define the modulating role of the COMT and DBH genotypes on prefrontal DA and impulsive behaviours in cannabis and cocaine abusers. The research program consists of two major studies in regular users of cannabis and cocaine (N=60 in both studies) that will be conducted in parallel at Maastricht University and Radboud University Nijmegen Medical Centre. In each study, subjects will receive single doses of placebo, a THC dose of maximal 20mg and cocaine HCl 300mg according to a double blind, cross-over design. Impulsivity will be assessed objectively after administration of cannabis and cocaine with several performance models of impulse control (e.g. stop signal task, Cued Go/NoGo task) as well as with event related potentials and fMRI. Performance data will be analyzed separately for each centre but also combined in a meta-analysis over 120 subjects. It is expected that acute challenges with cocaine and cannabis will induce two opposing dopaminergic states in the brain. That is, cocaine will stimulate dopamine release leading to hyperdopaminergia whereas cannabis will reduce central dopamine levels resulting in hypodopaminergia. At present the common assumption is that a state of hypodopaminergia will lead to an increase in impulsive and risky behaviours such as drug use. Yet, the present studies are expected to demonstrate that drug induced impulsive behaviours can occur during both dopaminergic states depending on COMT and DBH genotypes and type of drug.
- Main changes (audit trail)
- RECORD1-dec-2009 - 11-dec-2009


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