Cocaine Related DisordersNCT01189578
Brain Imaging of Cocaine Craving in Recreational Cocaine Users
An observational study of Cocaine Related Disorders, run by James J. Prisciandaro at 1 site in United States.
Trial summary
The purpose of this study is to compare individuals with cocaine dependence to recreational users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this comparison may help us better understand the transition from recreational to compulsive cocaine use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Related Disorders
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must report having used cocaine within the past 3 months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine, marijuana and alcohol.
- Use of one of the following methods of birth control by female subjects: birth control pills, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Subjects must live within a 50-mile radius of the research facility and have reliable transportation.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) prior to the experiment.
- Subjects must be right-handed.
Who cannot join
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
- Subjects with a history of or current psychotic disorder as this may impact cue reactivity.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine).
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, marijuana, or alcohol) within the past 60 days. Subjects may not meet criteria for cocaine dependence at any time.
- Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
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- Subjects with a history of epilepsy or seizure disorder.
- Subjects with significant liver impairment.
- The need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
- Clinically significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Neural Correlates of Craving and Impulsivity in Recreational Cocaine Users
The purpose of this study is to compare individuals with cocaine dependence to recreational users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this comparison may help us better understand the transition from recreational to compulsive cocaine use.
Read the detailed description
Chronic cocaine exposure is associated with an intensified and broadened pattern of neural reactivity to cocaine and cocaine cues; prolonged use is also associated with prefrontal abnormalities during response inhibition. Limited research suggests that recreational cocaine use has similar, but attenuated, effects on neural functioning. Unfortunately, very little research has directly compared cocaine dependent individuals and recreational cocaine users in terms of their neural reactivity to cocaine cues and response inhibition. Such comparisons could help to elucidate the pathological neuroplasticity associated with the transition from cocaine use to dependence. The proposed study will assess neural reactivity to cocaine cues and response inhibition in recreational cocaine users using fMRI. These data will be compared to data from the baseline visit of an ongoing IRB approved investigation (NCT00759473) in cocaine dependent individuals that is using the same experimental procedures as the proposed study.
- Conditions
- Cocaine Related Disorders
- Keywords
- Recreational, cocaine, fMRI, neuroimaging, craving, impulsivity
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior
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 |
|---|---|---|
| Recreational cocaine users | Individuals who have used cocaine in the past 3 months, but do not meet DSM-IV-TR diagnostic criteria for Cocaine Dependence. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Related DisordersStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Prisciandaro
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, James J. Prisciandaro, Medical University of South Carolina
- Investigators
- Kathleen T Brady, MD, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189578
- Sponsor's protocol ID
- HR# 20276
- Other IDs
- R01DA023188
- Status last verified
- Oct 2012
- First submitted
- 25 Aug 2010
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Craving and Impulsivity in Recreational Cocaine Users
- ClinicalTrials.gov ID
- NCT01189578
- Acronym / sponsor ID
- HR# 20276
- Conditions
- Cocaine Related Disorders
- Keywords
- Recreational, cocaine, fMRI, neuroimaging, craving, impulsivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- James J. PrisciandaroUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Aug 2010 (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 compare individuals with cocaine dependence to recreational users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this comparison may help us better understand the transition from recreational to compulsive cocaine use.
Detailed description
Chronic cocaine exposure is associated with an intensified and broadened pattern of neural reactivity to cocaine and cocaine cues; prolonged use is also associated with prefrontal abnormalities during response inhibition. Limited research suggests that recreational cocaine use has similar, but attenuated, effects on neural functioning. Unfortunately, very little research has directly compared cocaine dependent individuals and recreational cocaine users in terms of their neural reactivity to cocaine cues and response inhibition. Such comparisons could help to elucidate the pathological neuroplasticity associated with the transition from cocaine use to dependence. The proposed study will assess neural reactivity to cocaine cues and response inhibition in recreational cocaine users using fMRI. These data will be compared to data from the baseline visit of an ongoing IRB approved investigation (NCT00759473) in cocaine dependent individuals that is using the same experimental procedures as the proposed study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recreational cocaine users | – | –Individuals who have used cocaine in the past 3 months, but do not meet DSM-IV-TR diagnostic criteria for Cocaine Dependence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (6 listed)
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must report having used cocaine within the past 3 months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine, marijuana and alcohol.
- Use of one of the following methods of birth control by female subjects: birth control pills, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Subjects must live within a 50-mile radius of the research facility and have reliable transportation.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) prior to the experiment.
Key exclusion criteria (11 listed)
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
- Subjects with a history of or current psychotic disorder as this may impact cue reactivity.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine).
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, marijuana, or alcohol) within the past 60 days. Subjects may not meet criteria for cocaine dependence at any time.
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
Not reported in the source record.
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 29 Oct 2012.
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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.
Kathleen T Brady, MD, PhD principal investigator
Medical University of South Carolina
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 Related Disorders, run by James J. Prisciandaro 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 6 inclusion and 11 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 29 Oct 2012. 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.
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 29 Oct 2012.