The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders; Cocaine-Related Disorders
Intervention: Provigil (Modafinil) (Drug); Topamax (Topiramate) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Aviv M Weinstein, Ph.D, Study Director, Affiliation: Hadassah Medical Organization
Roland Chisin, M.D, Principal Investigator, Affiliation: Hadassah Medical Organization
Overall contact:
Aviv M Weinstein, Ph.D, Phone: 00 972 2 6776705, Email: vaviv@hadassah.org.il
Summary
The overall aim of this project is to use an advanced brain imaging technique, PET, in order
to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine
dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be
made within the cocaine dependent methadone maintained subjects, between the start and end of
treatment, and between the two medications. This is the first systematic research study of
pharmacological treatment for cocaine dependence in Israel. This study is of major clinical
use, with implications for the treatment of cocaine dependence in poly-drug abusers in
Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in
cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine
craving. Metabolic activity in regions that are activated by craving should be correlated
with dopamine DRD2 receptor occupancy in all patients.
Clinical Details
Official title: The Effects of Modafinil and Topiramate on Brain Mechanisms Underlying Cue-Induced Cocaine Craving and Dependence in Methadone Maintained Cocaine Dependent Patients.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment.Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment. Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period.
Secondary outcome: Craving and psychosocial functioning (e.g., employment status, criminal behavior).
Detailed description:
SPECIFIC AIMS
1. To try to elucidate the brain mechanisms underlying cocaine dependence and craving in
co-morbid cocaine-dependent patients. For this purpose we shall trigger craving for
cocaine by exposure to a videotape showing cocaine use and then measure brain metabolic
activity using Positron Emission Tomography (PET) and [18F] Fluorodeoxyglucose (FDG)
2. To evaluate dopamine binding in the brain in the early stage, and at the end of
treatment. For this purpose the patients will undergo brain imaging of the dopamine
receptor DRD2 by using PET with [11C] raclopride. This is a well established procedure
for quantifying the effects of drugs such as amphetamine and cocaine on the brain.
3. To investigate the association between subjective measures of craving for cocaine and
the level of dopamine DRD2 receptor occupancy in the brain.
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3
times a week
Exclusion Criteria:
- use more than 2g a day; 5 times a week to everyday
- Subjects who are diagnosed as suffering from psychotic illness according to DSM-IV
(Axis 1)22, or with a history of CNS disease, a history of infection that might affect
CNS (HIV, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of
consciousness,pregnant women.
Locations and Contacts
Aviv M Weinstein, Ph.D, Phone: 00 972 2 6776705, Email: vaviv@hadassah.org.il
Hadassah Medical Organization, Jerusalem 91120, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, Ph.D, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Aviv M Weinstein, Ph.D, Principal Investigator
Roland Chisin, M.D, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: April 2009
Last updated: May 6, 2008
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