Innovative approaches for cocaine pharmacotherapy using fMRI and SPECT: The case of rimonabant

Phase 3

Conditions: verslaving
cocaine addiction
drug dependence

Registration Number: NL-OMON31595

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

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

Exclusion Criteria:
1) Currently dependent on any substance other than cocaine or nicotine;
2) Severe neurological or psychiatric disorders (e.g., depression, psychosis, bipolar illness, dementia, or any diseases that require psychotropic medications);
3) Serious medical illnesses
4) Known hypersensitivity or allergy to rimonabant, or receiving chronic therapy with medication that could interact adversely with one of the medications under study, within 30 days prior to randomization;
5) Drugs known to influence binding to DA2 receptors, including neuroleptics, and methylphenidate
6) Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment
7) Clinically significant abnormal laboratory values;
8) 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Research assesing the availability of striatal D2 receptors.<br /><br>Craving and impulsivity.<br /><br>Research assesing the respons towards cocaine-associated cues.<br /><br><br /><br>Rimonabant may induce an increased availability of striatal D2 receptors. This<br /><br>could subsequently reduce craving to cocaine and/or impulsivity in human<br /><br>cocaine users.</p><br>

Secondary Outcome Measures