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View Clinical Trial (Medical Research Study)
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Effects of Smoking on Opioid Receptor Binding Using [(11)C]Carfentanil: an Imaging PET Study - NCT00618631-21224 (Clinical Trial 203473)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy203473.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21224 |
| Conditions: |
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Substance-related Discorder |
| Purpose: |
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Objective: To determine whether nicotine, at the dose delivered through a cigarette (1-2
mg), will increase the release of endogenous opioids, measured by the displacement of the
mu-opioid PET receptor radioligand [(11)C]carfentanil and to determine whether smokers have
adaptations in the opioid system compared with nonsmokers.
Study Population: 20 current, daily smoikers and 20 never-smokers who have smoked between 1
and 20 cigarettes in their lifetime.
Design: Double-blind, placebo-controlled, parallel groups design.
Outcome Measures: 1) displacement [(11)C]carfentanil binding, secondary to the release of
endorphins by nicotine; 2) upregulation of [(11)C]carfentanil specific binding in smokers
compared with nonsmokers; 3) [(11)C]carfentanil specific binding as a function of the
mu-opioid receptor A118G polymorphism; and 4) correlation between self-report measures of
nicotine effect and [(11)C]carfentanil binding profile....
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| Study summary: |
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Objective: To determine whether nicotine, at the dose delivered through a cigarette (1-2
mg), will increase the release of endogenous opioids, measured by the displacement of the
mu-opioid PET receptor radioligand [(11)C]carfentanil and to determine whether smokers have
adaptations in the opioid system compared with nonsmokers.
Study Population: 20 current, daily smoikers and 20 never-smokers who have smoked between 1
and 20 cigarettes in their lifetime.
Design: Double-blind, placebo-controlled, parallel groups design.
Outcome Measures: 1) displacement [(11)C]carfentanil binding, secondary to the release of
endorphins by nicotine; 2) upregulation of [(11)C]carfentanil specific binding in smokers
compared with nonsmokers; 3) [(11)C]carfentanil specific binding as a function of the
mu-opioid receptor A118G polymorphism; and 4) correlation between self-report measures of
nicotine effect and [(11)C]carfentanil binding profile. |
| Criteria: |
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- INCLUSION CRITERIA FOR SMOKERS:
1. 21-50 year old males and females
2. smoke 10-25 cigarettes per day on average for at least 2 years
3. urine cotinine level greater than or equal to 200 ng/ml (NicAlert reading
greater than or equal to 4)
4. estimated IQ score greater than or equal to 85 (competent to give informed
consent)
5. medically and psychologically healthy as determined by screening criteria.
EXCLUSION CRITERIA FOR SMOKERS:
1. interest in reducing or quitting tobacco use
2. treatment for nicotine dependence in the past 3 months
3. history of drug or alcohol dependence
4. consumption of more than 15 alcoholic drinks per week during the past month
5. use of any illicit drug during the past 6 months
6. current use of any medication that would interfere with the protocol
7. under the influence of a drug or alcohol at experimental sessions
8. HIV positive
9. history of psychotropic medications
10. history of head injury with unconscious longer than 5 minutes
11. implantable device or foreign body that would make an MRI examination unobtainable
12. MRI abnormality judged clinically significant by the PI
13. use of any investigational medication or device within the previous 30 days
14. donation at least 450 ml of blood or equivalent levels of plasma within the previous
30 days
15. exposure to ionizing radiation that, in combination with the study tracer, would
result in a cumulative exposure exceeding 5 rem in one calendar year
16. any subject judged by the PI to be inappropriate for the study.
17. chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema
18. pregnant, nursing, or become pregnant during the study
INCLUSION CRITERIA FOR NONSMOKERS:
1. 21-50 year old males and females
2. smoked 1-20 cigarettes in their life and none in past year
3. urine cotinine level less than 30 ng/ml (NicAlert reading less than or equal to 1)
4. estimated IQ score greater than or equal to 85 (competent to give informed consent)
5. medically and psychologically healthy as determined by screening criteria.
EXCLUSION CRITERIA FOR NONSMOKERS:
1. use of any tobacco products in the past year
2. history of drug or alcohol dependence
3. consumption of more than 15 alcoholic drinks per week during the past month
4. use of any illicit drug during the past 6 months
5. current use of any medication that would interfere with the protocol
6. under the influence of a drug or alcohol at experimental sessions
7. HIV positive
8. history of psychotropic medications
9. history of head injury with unconscious longer than 5 minutes
10. implantable device or foreign body that would make an MRI examination unobtainable
11. MRI abnormality judged clinically significant by the PI
12. use of any investigational medication or device within the previous 30 days
13. donation of at least 450 ml of blood or equivalent levels of plasma within the
previous 30 days
14. exposure to ionizing radiation that, in combination with the study tracer, would
result in a cumulative exposure exceeding 5 rem in one calendar year
15. any subject judged by the PI to be inappropriate for the study.
16. chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema
17. pregnant, nursing, or become pregnant during the study |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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