The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.
Primary Purpose
Opioid-Related Disorders, Cocaine-Related Disorders
Status
Suspended
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Provigil (Modafinil)
Topamax (Topiramate)
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Imaging, cocaine, methadone, craving, PET, FDG, D2, Modafinil, Topiramate
Eligibility 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.
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
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 Measures
Craving and psychosocial functioning (e.g., employment status, criminal behavior).
Full Information
NCT ID
NCT00396734
First Posted
November 6, 2006
Last Updated
June 9, 2010
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00396734
Brief Title
The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Suspended
Why Stopped
Grant was not renewed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
SPECIFIC AIMS
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)
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.
To investigate the association between subjective measures of craving for cocaine and the level of dopamine DRD2 receptor occupancy in the brain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Cocaine-Related Disorders
Keywords
Imaging, cocaine, methadone, craving, PET, FDG, D2, Modafinil, Topiramate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Provigil (Modafinil)
Intervention Description
Increase from 100mg to 400mg during 1 month of treatment
Intervention Type
Drug
Intervention Name(s)
Topamax (Topiramate)
Intervention Description
Increase from 25mg to 200mg in one month (double every week)
Primary Outcome Measure Information:
Title
Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment.
Time Frame
1 month
Title
Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment.
Time Frame
1 month
Title
Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Craving and psychosocial functioning (e.g., employment status, criminal behavior).
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviv M Weinstein, Ph.D
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roland Chisin, M.D
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.
We'll reach out to this number within 24 hrs