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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
Johns Hopkins University |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00618631 |
Purpose
Background:
Objectives:
Eligibility:
- Individuals 21 to 50 years of age who are either current smokers (10 to 25 cigarettes daily for at least 2 years) or have had some exposure to tobacco but have never smoked regularly (may have had a maximum of 20 cigarettes in their lifetime and none in past year).
Design:
| Condition | Intervention |
|---|---|
|
Substance-related Discorder |
Drug: Nicotine Drug: Carfentanil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Screening |
| 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.
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA FOR SMOKERS:
EXCLUSION CRITERIA FOR SMOKERS:
INCLUSION CRITERIA FOR NONSMOKERS:
EXCLUSION CRITERIA FOR NONSMOKERS:
Contacts and Locations| Contact: Kristen M. Mackowick | (443) 740-2290 | mackowickkm@mail.nih.gov |
| United States, Maryland | |
| National Institute on Drug Abuse | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Sub-Investigator: Mathew's Media Group Recruiting For more information contact | |
| Johns Hopkins Medical Institute | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
More Information
| Responsible Party: | Stephen J. Heishman, Ph.D./National Institute on Drug Abuse, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00618631 History of Changes |
| Other Study ID Numbers: | 999908060, 08-DA-N060 |
| Study First Received: | February 17, 2008 |
| Last Updated: | December 31, 2011 |
| Health Authority: | United States: Federal Government |
|
Smoking Nicotine Endogenous Opioids PET Study Carfentanil |
|
Smoking Habits Nicotine Nicotine polacrilex Carfentanil Analgesics, Opioid Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Analgesics Sensory System Agents Central Nervous System Depressants |