The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

Opioid-Related Disorders Clinical Trial

Official title:

The Effects of Modafinil and Topiramate on Brain Mechanisms Underlying Cue-induced Cocaine Craving and Dependence in Methadone Maintained Cocaine Dependent Patients.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00396734
• Other study ID #: 281006-HMO-CTIL
• Status: Suspended
• Phase: N/A
• First received: November 6, 2006
• Last updated: June 9, 2010
• Start date: April 2007
• Est. completion date: April 2011

Study information

• Verified date: June 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Opioid-Related Disorders

Intervention

Drug:
• Provigil (Modafinil)
Increase from 100mg to 400mg during 1 month of treatment
• Topamax (Topiramate)
Increase from 25mg to 200mg in one month (double every week)

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment.		1 month	No
Primary	Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment.		1 month	No
Primary	Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period.		1 month	No
Secondary	Craving and psychosocial functioning (e.g., employment status, criminal behavior).		1 month	No