Brain Imaging of Cocaine Craving in Recreational Cocaine Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James J. Prisciandaro, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01189578
First received: August 25, 2010
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to compare individuals with cocaine dependence to recreational users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this comparison may help us better understand the transition from recreational to compulsive cocaine use.


Condition
Cocaine Related Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Neural Correlates of Craving and Impulsivity in Recreational Cocaine Users

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Enrollment: 9
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Recreational cocaine users
Individuals who have used cocaine in the past 3 months, but do not meet DSM-IV-TR diagnostic criteria for Cocaine Dependence.

Detailed Description:

Chronic cocaine exposure is associated with an intensified and broadened pattern of neural reactivity to cocaine and cocaine cues; prolonged use is also associated with prefrontal abnormalities during response inhibition. Limited research suggests that recreational cocaine use has similar, but attenuated, effects on neural functioning. Unfortunately, very little research has directly compared cocaine dependent individuals and recreational cocaine users in terms of their neural reactivity to cocaine cues and response inhibition. Such comparisons could help to elucidate the pathological neuroplasticity associated with the transition from cocaine use to dependence. The proposed study will assess neural reactivity to cocaine cues and response inhibition in recreational cocaine users using fMRI. These data will be compared to data from the baseline visit of an ongoing IRB approved investigation (NCT00759473) in cocaine dependent individuals that is using the same experimental procedures as the proposed study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  • Subjects must report having used cocaine within the past 3 months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine, marijuana and alcohol.
  • Use of one of the following methods of birth control by female subjects: birth control pills, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
  • Subjects must live within a 50-mile radius of the research facility and have reliable transportation.
  • Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) prior to the experiment.
  • Subjects must be right-handed.

Exclusion Criteria:

  • Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  • Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
  • Subjects with a history of or current psychotic disorder as this may impact cue reactivity.
  • Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine).
  • Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, marijuana, or alcohol) within the past 60 days. Subjects may not meet criteria for cocaine dependence at any time.
  • Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
  • Subjects with a history of epilepsy or seizure disorder.
  • Subjects with significant liver impairment.
  • The need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
  • Clinically significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.
  • Persons with ferrous metal implants or pacemaker since fMRI will be used.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189578

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
James J. Prisciandaro
Investigators
Principal Investigator: Kathleen T Brady, MD, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: James J. Prisciandaro, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01189578     History of Changes
Other Study ID Numbers: HR# 20276, R01DA023188
Study First Received: August 25, 2010
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Recreational
cocaine
fMRI
neuroimaging
craving
impulsivity

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 21, 2014