The Effects of Expectation on Natural and Drug -Induced Rewards
2 other identifiers
observational
48
1 country
1
Brief Summary
Background:
- Environmental cues frequently induce expectancies in individuals that may strongly influence the actual experience associated with the cue. This has both positive and negative consequences for behavior and decision making. For instance, when an addicted individual experiences cues associated with imminent drug taking, an expectancy of the coming experience is also formed and very likely has an effect on the subsequent experience of the drug.
- Researchers are interested in studying how the brain responds to these kinds of environmental cues and expectancies in order to learn more about addiction and craving in substance-abusing individuals. Objectives:
- To compare the response to rewards (both drug-related and non-drug-related) in cocaine users and non-using individuals.
- To study the effect of expectation on reward-related (both drug-induced and non-drug-induced) responses and brain activity in cocaine users and non-using individuals. Eligibility:
- Individuals between 18 and 45 years of age who are regular cocaine users but otherwise healthy, or healthy individuals who are not cocaine users. Design:
- This study involves two experiments. Participants will be assigned to one or both experiments.
- Participants must not use any drugs for at least 3 days before the visit, may not consume alcohol for 24 hours before the visit, and may not consume caffeinated beverages for 12 hours before the visit. On the day of the visit, participants will provide both urine and breath samples to test for drug/alcohol use.
- Experiment 1: In the MRI scanner, participants will respond to questions and images on a screen, and will receive small amounts of flavored liquid (chocolate or cherry) through a tube in the mouth.
- Experiment 2: In the MRI scanner, participants will respond to questions and images on a screen, and will receive injections of liquid (saline solution or a drug that provides a high similar to cocaine) through an intravenous line. Participants in this experiment will return for follow-up visits and provide urine samples for further study.
- The specific assignment (to Experiment 1 or Experiment 2 or both experiments) will determine the number of study days and follow-up visits required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedStudy Start
First participant enrolled
May 24, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedApril 5, 2019
February 25, 2019
December 18, 2009
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the response to rewards (drug and non-drug related) in cocaine dependent and non- dependent individuals and study the effect of expectation on reward-related (both drug and non-drug induced) subjective responses and neuronal activity.
Secondary Outcomes (1)
To compare visual and olfactory cues as they relate to receipt of a non-drug reward. Olfactory cues follow a more direct path into the limbic system and thus, may alter reward system functioning differently than do visual cues.
Eligibility Criteria
You may qualify if:
- ALL PARTICIPANTS MUST:
- Be between the ages of 18-50.
- Be in good health.
- Be right-handed.
- Like the flavors of cherry Kool-Aid and Hershey's chocolate sauce.
- COCAIN DEPENDENT PARTICIPANTS MUST:
- Demonstrate that they area cocaine dependent.
- Be users of crack cocaine, free base cocaine or intravenous cocaine.
- Fe free of dependence on other substances except nicotine.
- Be free of abuse of other substances besides marijuana or alcohol.
- CONTROL PARTICIPANTS MUST:
- Be free of current or past DSM-IVTR substance use disorder except nicotine dependence or past substance abuse diagnosed iwth the single criterion of recurrent substance use in situations in which it is physically hazardous.
You may not qualify if:
- Participants will be excluded if they:
- Are not suitable to undergo an fMRI experiment due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia.
- Have cardiovascular disease, including but not limited to clinically significant arrhythmia, coronary artery disease and hypertension.
- Have coagulopathies, history of or current superficial or deep vein thrombosis, musculoskeletal abnormalities restricting an individual's ability to lie flat for extended periods of time.
- Have HIV or syphilis.
- Have any neurological illnesses to include, but not limited to, seizure disorders, frequent migraine, multiple sclerosis, movement disorders, or history of head traume, CVA, CNS tumor
- Have an abnormality on screening MRI scans that would place the participant at increased risk from blood pressure elevations related to protocol procedures (methylphenidate injections) or would impair the quality of data gathered on the participant.
- Have other major medical illnesses likely to interfere with study results or safety of an individual during participation.
- Have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced disorders.
- Regularly use any prescription, over-the-counter or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling.
- Are actively seeking or engaged in substance abuse treatment.
- Are lactating.
- Are cognitively impaired or learning disabled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224, United States
Related Publications (3)
Marlatt GA. Cue exposure and relapse prevention in the treatment of addictive behaviors. Addict Behav. 1990;15(4):395-9. doi: 10.1016/0306-4603(90)90048-3.
PMID: 2248112BACKGROUNDChildress AR, Hole AV, Ehrman RN, Robbins SJ, McLellan AT, O'Brien CP. Cue reactivity and cue reactivity interventions in drug dependence. NIDA Res Monogr. 1993;137:73-95.
PMID: 8289929BACKGROUNDIto R, Dalley JW, Robbins TW, Everitt BJ. Dopamine release in the dorsal striatum during cocaine-seeking behavior under the control of a drug-associated cue. J Neurosci. 2002 Jul 15;22(14):6247-53. doi: 10.1523/JNEUROSCI.22-14-06247.2002.
PMID: 12122083BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betty Jo Salmeron, M.D.
National Institute on Drug Abuse (NIDA)
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 21, 2009
Study Start
May 24, 2010
Study Completion
February 25, 2019
Last Updated
April 5, 2019
Record last verified: 2019-02-25