Psychology of Reward and Punishment: Functional and Molecular Brain Imaging and Monoaminergic Correlates
|First Received Date ICMJE||March 18, 2009|
|Last Updated Date||June 30, 2017|
|Start Date ICMJE||December 12, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00865332 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Psychology of Reward and Punishment: Functional and Molecular Brain Imaging and Monoaminergic Correlates|
|Official Title ICMJE||Psychology of Reward and Punishment: Functional and Molecular Brain Imaging and Monoaminergic Correlates|
- Individuals 18 to 45 years of age who are either current cocaine users or healthy volunteers with no history of substance abuse or dependence.
Objective: This protocol will integrate functional brain imaging of reward processing, together with assessment of the response to oral dextroamphetamine (d-AMPH), monoaminergic genotyping, and evaluation of past exposure to stress, in order to examine: (1) the relationship between these factors (i.e. dopamine function, brain activity, reward processing, genetic profile and exposure to stress) in normal healthy adults; and (2) variation in these factors between normal healthy adults and individuals with current cocaine-dependence, and how this variation contributes to observed behavioral and functional differences between these populations.
Study Population: The study populations will consist of adult (18-45 years old) healthy volunteers with no history of substance abuse or dependence and a matched group of individuals with current primary cocaine-dependence.
Experimental Design and Method: After being medically cleared and giving informed consent, each participant will undergo fMRI (four sessions, on separate days) and PET scanning (two sessions, on separate days). All brain imaging sessions will take place after single-blind administration of either d-AMPH (0.43 mg/kg orally) or placebo. Functional MRI will commence after dosing and will include several measures (both cognitive and affective) designed to activate neural circuitry involved in the processing of reward and punishment. PET scanning will also take place after d-AMPH or placebo and will involve administration of the radioligand [18F] Fallypride to assess CNS dopamine function.
Outcome Measures: This study is concerned with differences in the noted factors between experimental cohorts (controls vs. cocaine-dependent adults) and conditions (baseline vs. post d-AMPH). The primary outcome measures, used to ascertain these differences, will be: (1) the percentage change in fMRI BOLD signal during performance of measures of reward processing and cognitive function; (2) alterations or differences in the binding potential of [18F]Fallypride; (3) variations in genes related to DArgic function between individuals and groups, and the contribution of this variation to other outcome measures; and (4) history of exposure to stressful events and its role in behavioral and functional outcomes.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Estimated Completion Date||December 21, 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All participants in the cocaine group must meet DSM-IV criteria for cocaine dependence at the time of participation. Cocaine-dependent participants must also be positive for cocaine use in their urine toxicology screen.
Potential participants for either experimental group will be excluded from participation in this study according to the following criteria:
In addition to those criteria outlined above, potential control participants will be excluded if they meet the following criteria:
Candidates for the cocaine-dependent group will be excluded from the study if:
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00865332|
|Other Study ID Numbers ICMJE||080437
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Peter Herscovitch, M.D./Warren G. Magnuson Clinical Center, National Institutes of Health|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 21, 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP