Cocaine DependenceNCT00744601
Impulsivity, Neural Deficits and Cocaine Addiction
An observational study of Cocaine Dependence, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2012
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited from residential treatment programs at the VA North Texas Health Care System, Nexus Recovery Inc., and Homeward Bound Inc. Healthy controls will be recruited from the Greater Dallas community.
Who may be able to join
- Cocaine-dependence (patient population) or no cocaine-dependence (control population).
Who cannot join
- Other medical or psychiatric disorders that may effect neural functioning.
- Medications that may effect neural functioning.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas, Divison on Addictions
Dallas, Texas, 75390-8564
About this study
Official title: Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction
The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.
Read the detailed description
This study is designed to explore putative differences in impulsive behaviors and decision making in cocaine-addicted and healthy control subjects using functional magnetic resonance imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations in measures of impulsivity and decision-making when compared to healthy controls. That is, cocaine-addicted subjects will show both decreased activation and decreased resting measures of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity and decision-making. Furthermore, neurocognitive and neural deficits associated with impulsivity and decision-making will be associated with each other and with measures indicative of an impulsive relapse and altered decision making.
- Conditions
- Cocaine Dependence
- Keywords
- impulsivity, cocaine dependence, relapse, neuroimaging, functional magnetic resonance imaging (fMRI), single photon emission computed tomography (SPECT)
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Cocaine Addiction | |
| 2 | Healthy Control Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls.
Measured: 2 weeks
In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment.
Measured: 6 months
Secondary outcomes (1)
Assess the predictive validity of self-report measures of impulsive relapse.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Dallas VA Medical Center
- Responsible party
- Principal investigator, Bryon H Adinoff, University of Texas Southwestern Medical Center
- Investigators
- Bryon Adinoff, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744601
- Sponsor's protocol ID
- DA023203
- Other IDs
- 1R01DA023203-01
- Status last verified
- Dec 2012
- First submitted
- 19 Jun 2008
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction
- ClinicalTrials.gov ID
- NCT00744601
- Acronym / sponsor ID
- DA023203
- Conditions
- Cocaine Dependence
- Keywords
- impulsivity, cocaine dependence, relapse, neuroimaging, functional magnetic resonance imaging (fMRI), single photon emission computed tomography (SPECT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Dallas VA Medical Center
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Sep 2008 (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.
The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.
Detailed description
This study is designed to explore putative differences in impulsive behaviors and decision making in cocaine-addicted and healthy control subjects using functional magnetic resonance imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations in measures of impulsivity and decision-making when compared to healthy controls. That is, cocaine-addicted subjects will show both decreased activation and decreased resting measures of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity and decision-making. Furthermore, neurocognitive and neural deficits associated with impulsivity and decision-making will be associated with each other and with measures indicative of an impulsive relapse and altered decision making.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Cocaine Addiction |
| 2 | – | –Healthy Control Volunteers |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from residential treatment programs at the VA North Texas Health Care System, Nexus Recovery Inc., and Homeward Bound Inc. Healthy controls will be recruited from the Greater Dallas community.
Key inclusion criteria (1 listed)
- Cocaine-dependence (patient population) or no cocaine-dependence (control population).
Key exclusion criteria (2 listed)
- Other medical or psychiatric disorders that may effect neural functioning.
- Medications that may effect neural functioning.
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
Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls.
Time frame: 2 weeks
In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment.
Time frame: 6 months
1 secondary outcome
Assess the predictive validity of self-report measures of impulsive relapse.
Time frame: 6 months
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 3 Jan 2013.
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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.
Bryon Adinoff, MD principal investigator
UT Southwestern Medical Center at Dallas
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 Dependence, run by University of Texas Southwestern Medical Center 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 1 inclusion and 2 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 3 Jan 2013. 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?
Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2013.