Clinical trial: 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 (NCT01038245)

Eligibility criteria:
-  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 abuse (single illicit substance use of more than 30 times in a lifetime
             for any given substance, except marijuana) will be excluded from the study. However,
             if the use was greater than 10 times in a lifetime, it must have occurred more than 10
             years before enrollment in this protocol. Subjects may use moderate amounts of alcohol
             and caffeine and smoke an occasional marijuana cigarette. Moderate alcohol use will be
             defined as less than fourteen drinks of liquor (1.5 oz) or the equivalent beer (12 oz)
             or wine (5 oz) per week. Moderate caffeine use will be defined as less than 500 mg of
             caffeine per day, where 100 mg is equivalent to 1 serving of coffee (5 oz serving),
             2.5 servings (12 oz serving) of caffeinated soft drinks, or 2.5 servings of tea (5 oz
             serving). Occasional marijuana use will be defined as less than or equal to two
             marijuana cigarettes/month.

          -  Current Medication Use: Volunteers may not currently use chronic (daily or for more
             than 10/14 days in the last month) prescription or over the counter medications,
             (including, but not limited to, anti-hypertensive, anti-allergy, pain).

          -  CNS disease: History of known structural brain abnormalities (e.g., neoplasm,
             subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess),
             history of head trauma (defined as documented loss of consciousness > 5 min or injury
             requiring hospitalization), history of seizures as an adult, sleep apnea.

          -  Cardiovascular, pulmonary, or systemic disease: Repeated (measured on three separate
             occasions) diastolic blood pressure > 90 mm Hg, or systolic blood pressure > 150 mm
             Hg, known arrhythmia, symptomatic or known coronary artery disease; history of
             endocarditis, cerebral embolism, obstructive pulmonary disease, asthma, active
             tuberculosis, known endocrine disease (derangements in adrenal, thyroid, bone or
             reproductive function) known chronic renal or hepatic dysfunction, known HIV
             seropositive, known current autoimmune disease involving the CNS, type I diabetes
             mellitus, current gastrointestinal disease, gastritis or ulcers.

          -  Special considerations for female subjects. Female participants who are currently
             pregnant or nursing will not be allowed to participate in this study because of
             potential damage to the fetus or baby from the radiation. Female subjects will be
             given a serum pregnancy test (quantitative beta HCG) within 24 hours of each PET
             study.

          -  Radiation exposure: Any subject who has participated in any research studies in which
             he/she received a radiation exposure that would result in combination with the present
             study, in a total effective radiation exposure (from research studies) exceeding 3.0
             rem in a 13-week period or 5.0 rem in a year.

          -  Lack of bilateral arterial patency: Evidence of inadequate patency of radial and lunar
             arteries, determined by either Doppler flow measurements or a positive Allen's test,
             is an exclusionary criterion for insertion of an arterial catheter.

          -  Women who are pregnant or lactating and children under the age of 18 will be excluded
             to avoid unnecessary exposure to radiation to these populations.

          -  Presence in body of metallic implants or materials that could be moved by the magnet
             of the MRI scanner: pacemakers, surgical implants, aneurysm clips, dental braces,
             bullet(s) or other metallic materials.

          -  Miscellaneous exclusionary criteria: Body mass index less than 19 or greater than 30.
             Hematocrit < 39.0 for males or < 36.0 for females.

          -  Novocain allergy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 0