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Clinical Trial Summary

Background:

- Cocaine affects the brain's ability to process information. However, different people respond to cocaine in different ways, and differences in brain structure and function may affect how cocaine alters brain activity. By using functional magnetic resonance imaging (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope to better understand how the brain responds to rewards and how this response is affected by drugs like cocaine.

Objectives:

- To determine the effect of cocaine administration on the reward experience in cocaine-dependent individuals.

- To study genetic and personality factors that may contribute to cocaine dependence.

Eligibility:

- Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking treatment or are healthy volunteers.

Design:

- Participants will be asked to avoid consuming alcohol and restrict consumption of caffeine prior to the study. Participants provide urine and breath samples to be tested for chemicals that may interfere with the study.

- All participants will complete a training session and at least one fMRI scanning session. During the training session, participants will be introduced to the reward tasks and MRI equipment.

- Healthy volunteers will have a single fMRI session that will involve reward tasks to be completed during the scanning. Rewards will include small amounts of fruit juice and the opportunity to win money.

- Cocaine-dependent participants will have a training session and three experimental sessions including 1) a mock MRI scan to test cocaine tolerance, 2) one fMRI scan with reward tasks after administration of IV cocaine, and 3) one fMRI scan with reward tasks after administration of IV placebo (saline solution). Rewards will include small amounts of fruit juice and the opportunity to win money.

- In addition to the scans, participants will provide a blood sample for further study and will answer questionnaires provided by the researchers.


Clinical Trial Description

Objective:

The overall objective of this study is to determine the effect that cocaine administration has upon the experience of reward in dependent individuals and the contribution of reward processing (or dysfunction) to the reinforcing effects of cocaine and the recidivism rates noted in cocaine-dependent individuals. The primary goal is to employ functional magnetic resonance imaging (fMRI) to ascertain the function of neural systems that respond to cocaine in human participants and to determine the role that they play in the processing of different types of rewarding stimuli during episodes where individuals are drug-free and those where they are under the acute influence of cocaine.

Study Population:

The experimental population for this investigation will be non-treatment seeking, cocaine-dependent adults (i.e. 18 45 years old). A cohort of healthy, drug-free, individuals, matched for age, gender, ethnicity and IQ, will serve as a control group.

Design:

This experiment employs a mixed-measures, counter-balanced design. Participants will complete two measures of reward processing (i.e. the revised monetary incentive delay (MID) task and a temporal difference error task (TDE/juice) task) while undergoing BOLD EPI fMRI. The scanning procedure will be repeated for all subjects, such that each participant undertakes 2 sessions. Cocaine-dependent individuals will receive either two injections of cocaine (30 mg/70 kg body weight; intravenous (IV) administration) or two injections of saline during scanning. Within each session, each IV injection will be given approximately 10 minute prior to the start of one of the reward measures. The order of cocaine and saline scans will be randomized and participants will be blind to the experimental condition prior to participation.

Outcome Measures:

The primary outcome measures will be the neural substrates of reward processing and how these differ between cocaine-dependent individuals and controls, and the impact of acute cocaine administration upon brain function associated with reward function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01036074
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date March 17, 2005
Completion date April 8, 2013

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