Brain Function and Structure in Cocaine Dependence

November 21, 2017 updated by: Virginia Commonwealth University
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Specific Aims of this project are:

Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 1:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.

Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.

Hypothesis related to Aim 2:

Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

  1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
  2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
  3. Significant current suicidal or homicidal ideation
  4. Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
  5. Taking CNS active concomitant medications
  6. Taking medications known to have significant drug interactions with the study medication
  7. Having conditions of probation or parole requiring reports of drug use to officers of the court
  8. Impending incarceration
  9. Pregnant or breast feeding for female patients
  10. Inability to read, write, or speak English
  11. Having plans to leave the immediate geographical area within 3 months
  12. Unwillingness or not competent to sign a written informed consent form
  13. Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
  14. Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
  15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo daily for 8 weeks
Experimental: Medication (Citalopram 20mg)
Citalopram (20mg dose)
Drug: Citalopram
20 mg or 40 mg daily for 8 weeks
Other Names:
  • Celexa
  • Citalopram HBr
Experimental: Medication (Citalopram 40mg)
Citalopram 40mg dose
Drug: Citalopram
20 mg or 40 mg daily for 8 weeks
Other Names:
  • Celexa
  • Citalopram HBr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaine Use/Treatment Effectiveness Score (TES)
Time Frame: 8 weeks of treatment
Number of benzoylecgonine negative urines divided by the total number of urines collected
8 weeks of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI Brain Activation in Right Inferior Frontal Gyrus
Time Frame: Baseline
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.
Baseline
fMRI Brain Activation in Right Precentral Gyrus
Time Frame: Baseline
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.
Baseline
fMRI Brain Activation in Right Orlandic Operculum
Time Frame: Baseline
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Frederick G Moeller, M.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM15378
  • 2P50DA009262-16A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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