E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alcohol dependence Cocaine dependence |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is when all participants succesfully finished two fMRI sessions (second session with acute administration with medications or placebo) and follow-ups after 3 and 6 months after the second fMRI session. End of trial is when we can succesfully determine the effects of medications on brain activation patterns using fMRI, on subjective craving, on test performance and on relapse. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |