NCT01036074

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2013

Completed
Last Updated

December 17, 2019

Status Verified

April 8, 2013

First QC Date

December 18, 2009

Last Update Submit

December 14, 2019

Conditions

Keywords

Drug AbuseCocaineCocaine DependenceFunctional MRIPharmalogical MRIConditioning

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ALL PARTICIPANTS
  • Participants in both groups must be:
  • Generally healthy.
  • Right handed.
  • Males or non-pregnant/non-lactating females.
  • Between the ages of 18-45, for cocaine dependent participants; 18-50 for control participants.
  • Cocaine-dependent participants must also:
  • Meet DSM-IV criteria for dependence at the time of participation.
  • Be positive for cocaine use in their urine toxicology screen either at their screening visit or on another occasion prior to their entry to the study (please note that this could be as late as the day of study entry).
  • Use either injection or smoking as their primary route of cocaine administration.

You may not qualify if:

  • ALL PARTICIPANTS
  • Participants in both groups will be excluded from participation in this study if they:
  • Are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (e.g. cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia.
  • Suffer from any major medical illness that may effect central nervous function including (but not limited to): hypertension; clinically significant arrhythmia; cardiovascular disease; asthma; diabetes; peripheral vascular diseases; coagulopathies; history of superficial or deep vein thrombosis; HIV; or syphilis.
  • Have any neurological illnesses including (but not limited to): seizure disorders; migraine; multiple sclerosis; movement disorders; or history of head trauma, CVA, or CNS tumor.
  • Have a history of syncope
  • Have an estimated IQ of \< 85
  • Are lactating or pregnant
  • Are currently taking any psychoactive or vasoactive medication(s).
  • Meet DSM-IV criteria for dependence on alcohol or marijuana. Recreational use of alcohol and/or marijuana will be tolerated in all participants as will nicotine dependence.
  • COCAINE-DEPENDENT PARTICIPANTS
  • Cocaine-dependent individuals will also be excluded from participation if:
  • They have any current or previous history of any major psychiatric disorder other than cocaine dependence, including but not limited to mood, anxiety and psychotic disorders.
  • They have current dependence on any substance of abuse, other than cocaine or nicotine. However, current or past co-morbid abuse of alcohol, marijuana and past dependence on other substances of abuse will be tolerated in this group.
  • They have a history of adverse reaction to cocaine, such as cardiac arrhythmia or chest pain.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Akil M, Kolachana BS, Rothmond DA, Hyde TM, Weinberger DR, Kleinman JE. Catechol-O-methyltransferase genotype and dopamine regulation in the human brain. J Neurosci. 2003 Mar 15;23(6):2008-13. doi: 10.1523/JNEUROSCI.23-06-02008.2003.

    PMID: 12657658BACKGROUND
  • Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.

    PMID: 8126686BACKGROUND
  • Balster RL, Schuster CR. Fixed-interval schedule of cocaine reinforcement: effect of dose and infusion duration. J Exp Anal Behav. 1973 Jul;20(1):119-29. doi: 10.1901/jeab.1973.20-119.

    PMID: 4197505BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersCocaine-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Elliot Stein, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 21, 2009

Study Start

March 17, 2005

Study Completion

April 8, 2013

Last Updated

December 17, 2019

Record last verified: 2013-04-08

Locations