Cocaine AbuseNCT00217997
Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals
An observational study of Cocaine Abuse and Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Abuse, Cocaine-Related Disorders
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cocaine Dependent Subjects
Who may be able to join
- Meets DSM-IV criteria for cocaine dependence
- Met inclusion criteria for other cocaine dependence studies within the center grant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Impulsivity, Brain Function and Substance Abuse Treatment
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.
Read the 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.
- Conditions
- Cocaine Abuse, Cocaine-Related Disorders
- Keywords
- cocaine abuse, Cocaine-Related Disorders
- Medical subject headings
- Cocaine-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI brain activation
Baseline predictor of treatment response
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cocaine AbuseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Responsible party
- Sponsor
- Investigators
- Frederick G. Moeller, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217997
- Sponsor's protocol ID
- NIDA-09262-6
- Other IDs
- 5P50DA009262-17, P50-09262-6, DPMC
- Status last verified
- May 2017
- First submitted
- 16 Sep 2005
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23261866Liu 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.
PubMed 22047976Ma 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.
PubMed 21692148Liu 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.
PubMed 21204739Lane 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.
PubMed 20661285Narayana 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.
PubMed 20570057Schmitz 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.
PubMed 20155594
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulsivity, Brain Function and Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT00217997
- Acronym / sponsor ID
- NIDA-09262-6
- Conditions
- Cocaine Abuse, Cocaine-Related Disorders
- Keywords
- cocaine abuse, Cocaine-Related Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Study start
- Sep 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cocaine Dependent Subjects
Key inclusion criteria (2 listed)
- Meets DSM-IV criteria for cocaine dependence
- Met inclusion criteria for other cocaine dependence studies within the center grant
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI brain activation
Time frame: baseline
Baseline predictor of treatment response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 23261866Orru 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.
- Background: PubMed 22047976Liu 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.
- Background: PubMed 21692148Ma 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.
- Background: PubMed 21204739Liu 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.
- Background: PubMed 20661285Lane 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.
- Background: PubMed 20570057Narayana 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.
- Background: PubMed 20155594Schmitz 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.
Related trials for Cocaine Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Harm Reduction Services
Drug Use, Substance Abuse
RecruitingPhase 4
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
Cocaine Use Disorder, Crack Abuse or Dependence
Recruiting
Smartphone Services for Stimulant Use Disorder
Stimulant Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick G. Moeller, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Abuse and Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI brain activation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00217997, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.