Innovative approaches for cocaine pharmacotherapy using fMRI: The case of varenicline

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

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