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Completed

NCT Number: NCT02080832

Brain Function and Structure in Cocaine Dependence

The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Citalopram

Drug

20 mg or 40 mg daily for 8 weeks

Other names: Celexa, Citalopram HBr

Placebo

Drug

Placebo daily for 8 weeks

Primary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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