Nicotinic Receptor Availability and Smoking Cessation Success.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.
研究概览
简要总结
The investigators propose to use positron emission tomography (PET) imaging to determine whether nicotinic receptor availability at pretreatment predicts smoking cessation success. The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic receptor availability using the PET radioligand 2-[18F]FA, after overnight abstinence and prior to initiation of treatment.
详细描述
Subjects will be asked to complete a short screening session, an orientation phone call, and two imaging sessions: one PET imaging session and one MRI session.
Intake Session. This session will familiarize subjects with the study procedures and risks, as well as determine initial eligibility for the study. Subjects will first complete an Imaging Screening Form with study personnel. Subjects will also complete a Magnet Safety Form to check for any metal in the body. Finally, subjects will complete a Scanning Registration Form.
Orientation Call. Dr. Dubroff (the Principal Investigator and study physician) will call subjects before the PET Scan Session to review the study procedures and risks and answer any questions subjects might have.
PET Scan Session. Subjects will receive a telephone call the day before the session to remind them to stop smoking at 9:00pm that night. At the session, they will provide a series of samples. These include:
- A urine sample to assess for the presence of study-prohibited drugs and medications (including cocaine, opiates, benzodiazepines, amphetamines, methamphetamines, tri-cyclic antidepressants, methadone, PCP, and barbiturates).
- Women of childbearing age will be required to take a urine pregnancy test.
- A breath alcohol concentration (BrAC) measurement.
- A breath carbon monoxide (CO) reading.
- Have your weight measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •In addition to the exclusion criteria used for PNAT trial [NCT01314001], participants in this trial will be excluded if they meet the following criteria:
- •Imaging-Related Exclusion Criteria:
- •Weigh over 299 lbs.
- •Self-reported history of head trauma or brain (or CNS) tumor.
- •Self-reported history of claustrophobia (contraindicated for PET and MRI).
- •Cochlear implant or bilateral hearing aids.
- •Pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI.
- •History of gunshot wound (including BB guns).
- •Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
- •CO reading greater than 15ppm at the PET Scan Session (or at least a 50% reduction from the PNAT Intake Session).
- •BrAC reading greater than or equal to 0.01 at the PET Scan Session.
- •Positive urine drug screen for cocaine, phencyclidine, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, or barbiturates at the PNAT Intake Session or PET Scan Session.
- •Positive urine pregnancy (females only) screen at the PET Scan Session and/or MRI Scan Session.
- •Inability to give blood at the PET Scan Session (blood samples are required to analyze PET data).
- •Prior exposure to radioactive tracers in imaging studies or for medical reasons may be exclusionary.
- •General Exclusion Criteria:
- •Any medical condition, illness, disorder or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Co-investigators.
- •Inability to provide informed consent or complete the study procedures within 10 hours and/or correctly, as determined by the Principal Investigator or Co-investigators.
- •Any physical or visual impairment that would prevent completion of the cognitive tasks.
- •Participation (within the last 6 months) in other studies at our center involving similar cognitive testing procedures.
结局指标
主要结局
Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.
时间窗: following overnight nicotine abstinence
Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.
次要结局
- Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.(Before and immediately following the PET scan.)
研究者
Jacob Dubroff
Assistant Professor of Radiology
University of Pennsylvania