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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00618631 |
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....
Condition | Intervention |
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Substance-Related Discorder |
Drug: Nicotine Drug: Carfentanil |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Effects of Smoking on Opioid Receptor Binding Using [(11)C]Carfentanil: an Imaging PET Study |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
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.
Ages Eligible for Study: | 21 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA FOR SMOKERS:
EXCLUSION CRITERIA FOR SMOKERS:
INCLUSION CRITERIA FOR NONSMOKERS:
EXCLUSION CRITERIA FOR NONSMOKERS:
Contact: Rebecca Evans | (410) 550-1570 | evansre@intra.nida.nih.gov |
United States, Maryland | |
National Institute on Drug Abuse | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Johns Hopkins Medical Institute | Recruiting |
Baltimore, Maryland, United States, 21287 |
Study ID Numbers: | 999908060, 08-DA-N060 |
Study First Received: | February 17, 2008 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00618631 History of Changes |
Health Authority: | United States: Federal Government |
Smoking Nicotine Endogenous Opioids PET Study |
Carfentanil Smoking Nicotine |
Nicotine polacrilex Smoking Neurotransmitter Agents Nicotine Nicotinic Agonists Central Nervous System Depressants |
Carfentanil Peripheral Nervous System Agents Analgesics Cholinergic Agents Analgesics, Opioid |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Depressants Carfentanil Cholinergic Agents Pharmacologic Actions |
Sensory System Agents Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |