Psychology of Reward and Punishment: Functional and Molecular Brain Imaging and Monoaminergic Correlates

NCT00865332 | Withdrawn

• 2 other identifiers: 08043708-DA-0437
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Brain imaging studies, genetic research, and investigations of stress have provided more information about the role of dopamine in processing reward and punishment, and in vulnerability to substance dependence. Researchers are interested in learning more about how the brain responds to rewards, including drugs of abuse, and how these responses may involve genetic factors or previous stressful events.
• Researchers intend to use the drug amphetamine to increase levels of dopamine in the brain and study the effects through two kinds of scanning: functional magnetic resonance imaging (fMRI) and positron emission tomography (PET). Objectives:
• To examine the relationship among dopamine function, brain activity, reward processing, genetic profile and exposure to stress in normal healthy adults.
• To examine the variation in these factors between normal healthy adults and individuals with current cocaine-dependence. Eligibility: \- Individuals 18 to 45 years of age who are either current cocaine users or healthy volunteers with no history of substance abuse or dependence. Design:
• The study will consist of an initial evaluation session and six study visits, four of which will involve fMRI scans (3 hours each) and two of which will involve PET scans (8 to 9 hours each).
• Cocaine-using participants will enter the inpatient clinical research ward at the National Institute on Drug Abuse Addiction Research Center the night before each scanning session and will be discharged the following day. Healthy volunteer subjects will not be required to stay overnight and will arrive as outpatients for the PET session. Participants will not be released until researchers have determined that participants are not experiencing significant effects of the drug.
• Initial session (1): Participants will complete questionnaires about past reactions to stressful situations, and will be trained to do thinking tasks that will be performed in fMRI visits. The tasks will be practiced in a mockup of an MRI machine.
• MRI sessions (2-5): Participants will receive either oral amphetamine or a placebo, and will perform thinking, short-term memory, and reward tasks during MRI scanning as directed by researchers.
• PET sessions (6-8): Participants will receive either oral amphetamine or a placebo, and will provide blood samples during the PET scanning sessions. Participants will have short breaks during the PET scanning sessions.

Conditions

Cocaine Addiction; Cocaine Abuse

Keywords

PET; fMRI; D-Amphetamine; Cocaine Addiction; Methylphenidate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 - 45 years;
• In good health, based on history and physical examination; and
• Right-handed (as assessed using the Edinburgh Handedness Inventory; Oldfield, 1971)
• 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.

You may not qualify if:

• Potential participants for either experimental group will be excluded from participation in this study according to the following criteria:
• Current drug use: Subjects may smoke regular cigarettes, use moderate amounts of alcohol and caffeine, or smoke an occasional marijuana cigarette. Moderate alcohol use is defined as for men, less than ten drinks and for women less than 7 drinks of liquor (1.5 oz) or the equivalent beer (12 oz) or wine (5 oz) per week. Moderate caffeine use is defined as less than 500 mg of caffeine per day, where one 5-oz serving of coffee and 2 12-oz servings of caffeinated soft drinks or tea each contain 100 mg. Occasional marijuana use is defined as less than or equal to 2 cigarettes/month. Participants may not use alcohol or marijuana for at least 24 hours prior to scanning, but will be allowed to smoke regular cigarettes according to their normal usage pattern. Participants who do not meet these guidelines for current drug use will not be allowed to participate in this study.
• Cardiovascular, pulmonary, or systemic disease: Repeated (measured on three separate occasions) diastolic blood pressure \> 90 mm Hg, or systolic blood pressure \> 135 mm Hg, known arrhythmia, symptomatic or known coronary artery disease; history of endocarditis, cerebral embolism, obstructive pulmonary disease, asthma, active tuberculosis, known endocrine disease (derangements in adrenal, thyroid, bone or reproductive function), known chronic renal or hepatic dysfunction, known HIV seropositive, known current autoimmune disease involving the CNS, glaucoma, allergy to amphetamine, dextroamphetamine or known hypersensitivity to sympathomimetic amines.
• Female participants who are currently pregnant or nursing will not be allowed to participate in this study. Female subjects will be given a serum pregnancy test a maximum of 24 hours prior to each PET session and a urine pregnancy test on the day of each fMRI session.
• Radiation exposure: Any subject who has participated in any research studies in which he/she received a radiation exposure or has been exposed to radiation for medical or other purpose , which in combination with the present study would result in a total effective radiation exposure (from research studies) exceeding 5.0 rem in a year will be excluded.
• Children under the age of 18 will be excluded to avoid unnecessary exposure to radiation to this population.
• Control Participants
• In addition to those criteria outlined above, potential control participants will be excluded if they meet the following criteria:
• Current or past psychiatric illness: DSM-IV criteria will be used (DSM-IV, APA, 1994) to determine this criterion. No subject with a current axis I diagnosis will be allowed to participate.
• History of Drug Abuse: Control volunteers reporting either current or a significant history of illicit drug abuse (defined as single illicit substance use of more than 30 times in a lifetime for any given substance, except marijuana) will be excluded from the study.
• Positive urine toxicology screen for either amphetamines or cocaine prior to study participation.
• Cocaine-Dependent Subjects
• Candidates for the cocaine-dependent group will be excluded from the study if:
• They are actively seeking or engaged in substance abuse treatment.
• They are dependent on other substances except nicotine or cocaine at the time of participation.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (2)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Aharon I, Etcoff N, Ariely D, Chabris CF, O'Connor E, Breiter HC. Beautiful faces have variable reward value: fMRI and behavioral evidence. Neuron. 2001 Nov 8;32(3):537-51. doi: 10.1016/s0896-6273(01)00491-3.

  PMID: 11709163 BACKGROUND

• Angrist B, Corwin J, Bartlik B, Cooper T. Early pharmacokinetics and clinical effects of oral D-amphetamine in normal subjects. Biol Psychiatry. 1987 Nov;22(11):1357-68. doi: 10.1016/0006-3223(87)90070-9.

  PMID: 3663788 BACKGROUND

• Arnsten AF, Goldman-Rakic PS. Noise stress impairs prefrontal cortical cognitive function in monkeys: evidence for a hyperdopaminergic mechanism. Arch Gen Psychiatry. 1998 Apr;55(4):362-8. doi: 10.1001/archpsyc.55.4.362.

  PMID: 9554432 BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: December 12, 2007
• Study Completion: December 21, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-12-21

Locations

US (2)