E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To determine the therapeutic effects of varencline in patients with cocaine addiction |
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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 |
1. Male, age 18-60 years; 2. Current DSM-IV diagnosis of cocaine dependence, but recently detoxified and abstinent; 3. Able to provide written informed consent and to comply with all study procedures
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E.4 | Principal exclusion criteria |
1. Currently dependent on any substance other than cocaine or nicotine; 2. History of depression that could be defined as even a single episode or recurrent episodes of depression, or depression necessitating hospitalization, or history of suicide attempt (see fotenote1); 3. Severe neurological or psychiatric disorders (e.g., psychosis, bipolar illness, dementia, or any diseases that require psychotropic medications); 4. Serious medical illnesses; 5. Known hypersensitivity or allergy to varenicline, or receiving chronic therapy with medication that could interact adversely with one of the medications under study, within 30 days prior to randomization; 6. Drugs known to influence binding to DA2 receptors, including neuroleptics, and methylphenidate; 7. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment; 8. Clinically significant abnormal laboratory values, as measured by the treatment centre; 9. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication. 10. Hypersensitivity to Jodium
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E.5 End points |
E.5.1 | Primary end point(s) |
Determine the therapeutic effect of varenicline in patients with cocaine addiction using fMRI and neuropsychological assessments |
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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 | Yes |
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 | No |
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 | Yes |
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
|
Determine the therapeutic effects of varenicline in patients with cocaine addiction using fMRI and neuropsychological assessments during an 8-week period. |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |