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

Phase 3
Conditions
verslaving
cocaine addiction
drug dependence
Registration Number
NL-OMON33821
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

1. male, aged 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.

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;
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Craving and impulsivity.<br /><br>Research assesing the respons towards cocaine-associated cues.<br /><br><br /><br>Varenicline may reduce craving to cocaine and/or impulsivity in human cocaine<br /><br>users.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>not applicable</p><br>
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