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Brain Function and Structure in Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Citalopram

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring substance abuse, cocaine, impulsivity, serotonin, MRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Medication (Citalopram 20mg)

Placebo

Medication (Citalopram 40mg)

Arm Description

Citalopram (20mg dose)

Citalopram 40mg dose

Outcomes

Primary Outcome Measures

Cocaine Use/Treatment Effectiveness Score (TES)

Number of benzoylecgonine negative urines divided by the total number of urines collected

Secondary Outcome Measures

Full Information

NCT ID

NCT02080832

First Posted

March 4, 2014

Last Updated

November 21, 2017

Sponsor

Virginia Commonwealth University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02080832

Brief Title

Brain Function and Structure in Cocaine Dependence

Official Title

Brain Function and Structure in Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

February 2010 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

Keywords

substance abuse, cocaine, impulsivity, serotonin, MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medication (Citalopram 20mg)

Arm Type

Experimental

Arm Description

Citalopram (20mg dose)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Medication (Citalopram 40mg)

Arm Type

Experimental

Arm Description

Citalopram 40mg dose

Intervention Type

Drug

Intervention Name(s)

Citalopram

Other Intervention Name(s)

Celexa, Citalopram HBr

Intervention Description

20 mg or 40 mg daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily for 8 weeks

Primary Outcome Measure Information:

Title

Cocaine Use/Treatment Effectiveness Score (TES)

Description

Number of benzoylecgonine negative urines divided by the total number of urines collected

Time Frame

8 weeks of treatment

Other Pre-specified Outcome Measures:

Title

fMRI Brain Activation in Right Inferior Frontal Gyrus

Description

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.

Time Frame

Baseline

Title

fMRI Brain Activation in Right Precentral Gyrus

Description

Time Frame

Baseline

Title

fMRI Brain Activation in Right Orlandic Operculum

Description

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick G Moeller, M.D.

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

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Brain Function and Structure in Cocaine Dependence

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