The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine

Status Suspended

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00396734
Study type	Interventional
Source	Hadassah Medical Organization
Contact
Status	Suspended
Phase	N/A
Start date	April 2007
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03950492` - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder	N/A
Completed	`NCT00000335` - Activity Monitoring Assessment of Opiate Withdrawal - 4	Phase 2
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Enrolling by invitation	`NCT06084221` - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems	N/A
Completed	`NCT02978417` - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings	Phase 4
Withdrawn	`NCT03137017` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults	Phase 1
Withdrawn	`NCT03137030` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults	Phase 1
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Completed	`NCT00710385` - Abuse Liability of Suboxone Versus Subutex	Phase 3
Completed	`NCT00142935` - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1	N/A
Completed	`NCT00218309` - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals	Phase 2
Completed	`NCT00067184` - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Terminated	`NCT00000243` - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone	N/A
Completed	`NCT00000264` - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16	N/A
Completed	`NCT00000257` - Effects of Alcohol History on Effects of Nitrous Oxide - 9	N/A
Completed	`NCT00000279` - Novel Medications for Opiate Detoxification - 4	Phase 2
Completed	`NCT00000306` - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3	Phase 2
Completed	`NCT00000249` - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1	Phase 2
Recruiting	`NCT04933084` - Pre-operative Education Modalities to Decrease Opioid Use	N/A
Recruiting	`NCT03610672` - Mobile Intervention for Young Opioid Users	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms