cocaine addiction
Conditions
Interventions
Trade Name: Champix (Europe)
Product Name: varenicline
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Academical Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the therapeutic effects of varencline in patients with cocaine addiction;Secondary Objective: ;Primary end point(s): Determine the therapeutic effect of varenicline in patients with cocaine addiction using fMRI and neuropsychological assessments | — |
Countries
Netherlands
Outcome results
None listed