Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence

• Register: ClinicalTrials.gov
• Last refreshed on: 27 May 2013
• Main ID: NCT01034384
• Date of registration: 16/12/2009
• Primary sponsor: National Institute on Drug Abuse (NIDA)
• Public title: Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
• Scientific title: Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence
• Date of first enrolment: December 2000
• Target sample size: 125
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01034384
• Study type: Observational
• Study design: Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Michael T Collins, M.D.
• Affiliation: National Institute of Dental and Craniofacial Research (NIDCR)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

All participants must be:

1. Between the ages of 18-50.

2. In good health.

3. Right-handed.

4. Free of past or present abuse and dependence on other substances (except nicotine).

5. Able to abstain from alcohol for 24 hours before each experiment session and no more
than 50 mg of caffeine (about 1/2 cup of coffee or a 12 oz cola) for 12 hours before
each neuroimaging session.

6. Male.

Smokers must be:

1. Regular smokers of greater than or equal to 15 cigarettes other than ultra-low nicotine
cigarettes per day for at least two years with evidence of withdrawal symptoms when having
stopped smoking for several hours (planes, theater, etc).

Nonsmokers must:

1. Have smoked less than or equal to 5 cigarettes in their lifetime, and no cigarettes or
any tobacco product in the past 5 years, and expired air CO < 8ppm.

EXCLUSION CRITERIA:

Participants will be excluded if they:

1. Are not suitable to undergo an fMRI experiment due to implanted metallic devices
(cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical
clips or other implanted metal parts), body morphology or claustrophobia.

2. Have coagulopathies, history of or current superficial, or deep vein thrombosis, or
musculoskeletal abnormalities restricting an individual's ability to lie flat for
extended periods of time.

3. Have HIV or Syphilis.

4. Have any neurological illnesses to include, but not limited to, seizure disorders,
migraine (> 2/yr or on prophylaxis), multiple sclerosis, movement disorders, or
history of significant head trauma, CVA, CNS tumor.

5. Have other major medical illnesses likely to interfere with study results or safety
of an individual during participation.

- Hemoglobin < 10 g/dl

- White Blood Cell Count < 2400/microliters

- Liver Function Tests > 3 times normal

- Serum glucose > 200 mg/dl

- Urine protein > 2 plus

6. Have any current major psychiatric disorders to include, but not limited to, mood,
anxiety, psychotic disorders, or substance-induced psychiatric disorders.

7. Regularly use any prescription, over-the-counter or herbal medication that may alter
CNS function, cardiovascular function or neuronal-vascular coupling.

8. Are cognitively impaired or learning disabled.

9. Significant cardiovascular or cerebrovascular diseases.

INCLUSION CRITERIA (Pilot Studies):

Smokers:

- regular cigarette smokers smoking greater than or equal to 10 cigarettes/day for at
least 1 year

- no intention to reduce or quit tobacco use

- age between 18 and 45 years

- men



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking Cessation

Primary Outcome(s)

Subjective withdrawal symptoms, cognitive performance, vital signs, MAO-A and MAO-B parameters, hormonal parameters, EEG, cigarette liking, expired air CO, and functional brain activity.

Secondary ID(s)

01-DA-N357

999901357

Source(s) of Monetary Support

Please refer to primary and secondary sponsors