Quantitation of Human Cerebral Nicotinie Receptors With 2[18F]FA-85380 and PET Healthy Non-smoker… (NCT01038245) | Clinical Trial Compass
CompletedNot Applicable
Quantitation of Human Cerebral Nicotinie Receptors With 2[18F]FA-85380 and PET Healthy Non-smokers and Ex-Smokers and in Heavy and Light Situational Smokers
United States72 participantsStarted 2003-07-08
Plain-language summary
Background:
\- Central nicotinic acetylcholine receptors (nAChRs) are primary targets for the action of nicotine. In addition to being involved in tobacco dependence, they are also involved in a variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are interested in developing better ways to study the action of nAChRs to improve treatments for smoking cessation and other problems affected by these receptors. These new study methods may involve different approaches to positron emission tomography (PET) scanning, which can show brain activity related to nAChRs.
Objectives:
\- To evaluate appropriate and useful doses of radiotracers used in PET scanning of nAChRs in the brains of nonsmokers/former smokers, light smokers, and heavy smokers.
Eligibility:
\- Individuals between 18 and 50 years of age who fall into one of the following groups: (1) nonsmokers or former smokers who have not smoked for the past 2 years, (2) light/situational smokers, or (3) heavy smokers (at least 15 cigarettes/day for the past 2 years).
Design:
* Each participant will undergo up to three PET studies, given approximately1 month apart. Each study will take approximately 8 hours to complete.
* Participants will provide urine and breath samples before the study and at the start of the study, which will be tested for chemicals that may interfere with the study.
* Depending on the study, some of the smoking participants may receive a nicotine patch to wear during the PET scan.
* On the day of the study, participants will receive a dose of a radiotracer (a drug used in PET scanning) given either as a single injection or as an injection followed by a continuous infusion, and will have a series of PET scans over the next 7 hours and provide blood samples during that time.
* Participants will return for a follow-up visit 1 month after the end of the study.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age: Subjects will be male and female volunteers aged 18 to 50 years.
* All subjects must have a stable point of contact and must agree to participate in three PET studies at approximately 4-week intervals.
* All participants in the light or heavy smoker groups must have smoking experience. Those in the heavy smoker group must smoke at least 15 cigarettes/day and have smoked for at least the last 2 consecutive years. Those participants in the light smoker group should be situational smokers (those who often smoke while consuming alcohol or in another type of situation, but who do not smoke daily). Light smokers should have not smoked more than 1 cigarette in the week before starting the medical screening process and agree to not smoke for the week before the first PET study (except for the single cigarette we ask them to smoke). Participants in the heavy smoker group should have experience with abstaining from smoking for at least 48 h. Subjects in the control group must be nonsmokers or have ceased smoking at least two years before the start of the study.
EXCLUSION CRITERIA:
* Weight: Anyone weighing more than 300 lbs is excluded from the study.
* Psychiatric disease: DSM-IV criteria will be used (American Psychiatric Association, 1994). No subject with a current axis I diagnosis will be allowed. No subject with known claustrophobia will be allowed.
* History of Drug Abuse: Volunteers reporting current or having a significant history of illicit drug…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.