Impulsivity, a risk factor in relapse to substance use disorder: investigating neural substrates before and after pharmacological challenges

• Conditions: Alcohol dependenceCocaine dependence

• Registration Number: EUCTR2008-005538-59-NL
• Lead Sponsor: ZonMw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

·Male, age 18-60 years;
·For the alcohol dependent group: current DSM-IV diagnosis of alcohol dependence, but recently detoxified and abstinent and not using benzodiazepines for at least one week;
·For the cocaine dependent group: current DSM-IV diagnosis of cocaine dependence, but recently detoxified and abstinent;
·For the healthy control group: matched on gender, ethnicity, age and education to the alcohol and cocaine dependent groups.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Current use of prescription or illicit psychoactive drugs;
·Lifetime history of head injury with loss of consciousness for more than 5 minutes;
·Serious neurological or psychiatric disorders (e.g. psychosis, dementia, bipolar disorder)
.People with depressive symptoms will be excluded.
·More than 100 lifetime uses of any class of drug of abuse other than alcohol (alcohol group) or cocaine (cocaine group);
·Being on an active low-calorie (<1000 calories/day) diet;
·Unstable medical illness (e.g. hypertension, diabetes, myocardial infarct);
·Colour blindness;
·Currently dependent on cocaine for the alcohol dependent group and alcohol for the cocaine dependent group.
·Less than a lower level education until age 16;
·With respect to MRI imaging: claustrophobia; presence of non-removable metal objects, use of psychotropic medication.
·With respect to the medications: use of medication affecting the central nerve system (such as anti-depressants); hypersensitivity for modafinil or rimonabant; use of medication that increases the amount of rimonabant in the blood; any disease of the gastrointestinal system, liver or kidneys.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The goals of the proposed study are: (1) to further elucidate the relations between impulse control, motivational strength of drug cues, and brain activation patterns (using fMRI); (2) to examine the relative strength by which these processes are linked to vulnerability to relapse; and (3) to explore whether pharmacological approaches that improve cognitive functioning may provide new vistas for intervention strategies in the clinical management of alcohol and drug dependence (using pharmacological challenges with modafinil and rimonabant). ;Secondary Objective: ;Primary end point(s): Primary outcome variables are: (a) test performance, (b) craving ratings, (c) fMRI activation patterns, (d) relapse. In addition, DNA samples will be taken in order to investigate different polymorphisms in dopamine receptor genes (DRD2 and DRD4) and the Catechol-O-Methyltransferease (COMT) gene, and polymorphisms in the serotonin transporter gene and the gene encoding for the NMDA receptor subunit NR2A.