NCT01189578

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

August 25, 2010

Last Update Submit

October 25, 2012

Conditions

Keywords

RecreationalcocainefMRIneuroimagingcravingimpulsivity

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersImpulsive Behavior

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Kathleen T Brady, MD, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations