Impulsivity, Brain Function, and Substance Abuse Treatmen... | NCT00217997

Studies
Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals

NCT00217997

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

192Actual

Phase

Not provided

Conditions

Cocaine Abuse
Cocaine-Related Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2017

Last Update Posted Date

May 9, 2017Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH
University of Texas	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this trial is to evaluate aspects of treatment response in cocaine dependent individuals.

Detailed Description

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. The purpose of this study is to determine how impulsivity and prefrontal cortical function are related to treatment response in cocaine dependent individuals.

Participants in this study will complete four separate experiments, each with a different aim and testing panel [cognitive function tests with and without functional magnetic resonance imaging (fMRI)]. The first experiment will examine memory, attention, cognitive function, and impulsivity; the aim is to determine the relationship between impulsivity and cognitive function in cocaine dependent individuals receiving treatment. The second experiment will examine the relationship between impulsivity and the prefrontal cortical structure and function. Participants will complete an fMRI during the second experiment. The third experiment will consist of cognitive function tests and will examine the prefrontal cortex in relation to treatment response, based on four different treatments: 1) L-dopamine, 2) naltrexone, 3) modafinil, and 4) placebo. The fourth experiment will examine the effect of cocaine dependence treatment on prefrontal cortex, focusing on participants receiving modafinil.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

192Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fMRI brain activation	Baseline predictor of treatment response	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets DSM-IV criteria for cocaine dependence
Met inclusion criteria for other cocaine dependence studies within the center grant

Exclusion Criteria:

Current or history of DSM-IV Axis I disorders, other than substance abuse or dependence
Lifetime diagnosis of alcohol dependence
Serious non-psychiatric medical illness requiring ongoing medical treatment or one that affects the central nervous system
Positive urine drug screen test for drugs of abuse other than cocaine at the time of study entry
AIDS-defining illness
Intelligence Quotient (IQ) below 70
Pregnant
Uses a pacemaker, metal or electromechanical implants, or metallic foreign bodies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Cocaine Dependent Subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederick G. Moeller, PhD	University of Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center		Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23261866	Background	Orru M, Guitart X, Karcz-Kubicha M, Solinas M, Justinova Z, Barodia SK, Zanoveli J, Cortes A, Lluis C, Casado V, Moeller FG, Ferre S. Psychostimulant pharmacological profile of paraxanthine, the main metabolite of caffeine in humans. Neuropharmacology. 2013 Apr;67:476-84. doi: 10.1016/j.neuropharm.2012.11.029. Epub 2012 Dec 19.
22047976	Background	Liu S, Lane SD, Schmitz JM, Green CE, Cunningham KA, Moeller FG. Increased intra-individual reaction time variability in cocaine-dependent subjects: role of cocaine-related cues. Addict Behav. 2012 Feb;37(2):193-7. doi: 10.1016/j.addbeh.2011.10.003. Epub 2011 Oct 12.

ID	Type	Link
5P50DA009262-17	U.S. NIH Grant/Contract	View source
P50-09262-6
DPMC

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders