NCT00217997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

7.3 years

First QC Date

September 16, 2005

Last Update Submit

May 5, 2017

Conditions

Cocaine AbuseCocaine-Related Disorders

Keywords

cocaine abuseCocaine-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • fMRI brain activation

    Baseline predictor of treatment response

    baseline

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Cocaine Dependent Subjects

You may qualify if:

  • Meets DSM-IV criteria for cocaine dependence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (7)

  • 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.

    PMID: 23261866BACKGROUND

  • 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.

    PMID: 22047976BACKGROUND

  • Ma L, Steinberg JL, Hasan KM, Narayana PA, Kramer LA, Moeller FG. Working memory load modulation of parieto-frontal connections: evidence from dynamic causal modeling. Hum Brain Mapp. 2012 Aug;33(8):1850-67. doi: 10.1002/hbm.21329. Epub 2011 Jun 20.

    PMID: 21692148BACKGROUND

  • Liu S, Lane SD, Schmitz JM, Waters AJ, Cunningham KA, Moeller FG. Relationship between attentional bias to cocaine-related stimuli and impulsivity in cocaine-dependent subjects. Am J Drug Alcohol Abuse. 2011 Mar;37(2):117-22. doi: 10.3109/00952990.2010.543204. Epub 2011 Jan 5.

    PMID: 21204739BACKGROUND

  • Lane SD, Steinberg JL, Ma L, Hasan KM, Kramer LA, Zuniga EA, Narayana PA, Moeller FG. Diffusion tensor imaging and decision making in cocaine dependence. PLoS One. 2010 Jul 16;5(7):e11591. doi: 10.1371/journal.pone.0011591.

    PMID: 20661285BACKGROUND

  • Narayana PA, Datta S, Tao G, Steinberg JL, Moeller FG. Effect of cocaine on structural changes in brain: MRI volumetry using tensor-based morphometry. Drug Alcohol Depend. 2010 Oct 1;111(3):191-9. doi: 10.1016/j.drugalcdep.2010.04.012. Epub 2010 May 31.

    PMID: 20570057BACKGROUND

  • Schmitz JM, Mooney ME, Green CE, Lane SD, Steinberg JL, Swann AC, Moeller FG. Baseline neurocognitive profiles differentiate abstainers and non-abstainers in a cocaine clinical trial. J Addict Dis. 2009 Jul;28(3):250-7. doi: 10.1080/10550880903028502.

    PMID: 20155594BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Frederick G. Moeller, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

US(1)