The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

NCT00396734 | Suspended DMC

• 1 other identifier: 281006-HMO-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders; Cocaine-Related Disorders

Keywords

Imaging; cocaine; methadone; craving; PET; FDG; D2; Modafinil; Topiramate

Outcome Measures

Primary Outcomes (3)

• Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment.

  1 month

• Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment.

  1 month

• Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period.

  1 month

Secondary Outcomes (1)

• Craving and psychosocial functioning (e.g., employment status, criminal behavior).

  1 month

Interventions

Provigil (Modafinil) DRUG

Increase from 100mg to 400mg during 1 month of treatment

Topamax (Topiramate) DRUG

Increase from 25mg to 200mg in one month (double every week)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3 times a week

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Cocaine-Related Disorders

Interventions

Modafinil; Topiramate

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Aviv M Weinstein, Ph.D

  Hadassah Medical Organization

  STUDY DIRECTOR

• Roland Chisin, M.D

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: April 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

IL (1)