Brain Function and Structure in Cocaine Dependence

NCT02080832 | Completed Phase 2 Results DMC

• 2 other identifiers: HM153782P50DA009262-16A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

substance abuse; cocaine; impulsivity; serotonin; MRI

Outcome Measures

Primary Outcomes (1)

• Cocaine Use/Treatment Effectiveness Score (TES)

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

  8 weeks of treatment

Other Outcomes (3)

• fMRI Brain Activation in Right Inferior Frontal Gyrus

  Baseline

• fMRI Brain Activation in Right Precentral Gyrus

  Baseline

• fMRI Brain Activation in Right Orlandic Operculum

  Baseline

Study Arms (3)

Medication (Citalopram 20mg)

EXPERIMENTAL

Citalopram (20mg dose)

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Medication (Citalopram 40mg)

EXPERIMENTAL

Citalopram 40mg dose

Drug: Citalopram

Interventions

Citalopram DRUG

20 mg or 40 mg daily for 8 weeks

Also known as: Celexa, Citalopram HBr

Medication (Citalopram 20mg); Medication (Citalopram 40mg)

Placebo DRUG

Placebo daily for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• The University of Texas Health Science Center, Houston: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Impulsive Behavior

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Results should be viewed with caution due to small sample size. Data was only analyzed from participants who underwent MRI scans at UT Houston as data could not be combined with MRI scans at VCU.

Results Point of Contact

• Title: F. Gerard Moeller, M.D.
• Organization: VCU

frederick.moeller@vcuhealth.org

804-828-4134

Study Officials

• Frederick G Moeller, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: February 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 26, 2017
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Locations

US (1)