Effects of Nicotine on Brain Activity as Measured by fMRI

NCT01037153 | Completed

• 2 other identifiers: 99990237102-DA-N371
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments. Objectives: \- To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers. Eligibility: \- Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age. Design:

• The study involves five separate research experiments. Most participants will be involved in only one experiment.
• The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study.
• Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine.
• Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours.
• Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette).
• Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session.
• Experiment 5: Participants will have three fMRI sessions that will involve looking at different kinds of pictures related to or not related to smoking after receiving a single injection of nicotine.
• Participants will also provide blood samples for further study....

Conditions

Nicotine Dependence; Drug Abuse

Keywords

Intravenous; Rate of Delivery; Dose Responses; Variable Intervals; Multiple Rapid Injections

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be between the ages of 18 - 50 and in good health, based on history and physical exam, and must demonstrate that they are experienced nicotine users based upon urine nicotine/cotinine levels or exhaled CO.
• Subjects must smoke a minimum of 20 cigarettes/day for at least 1 year.
• Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence on either and must have a negative urine drug triage prior to scanning.

You may not qualify if:

• Subjects will be excluded if:
• they are unable to undergo MRI scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
• they have any major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis, HIV, or other infectious diseases that may affect the CNS (e.g. syphilis).
• they have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
• they have history of neurological illnesses such as seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, or CNS tumor.
• they have alcohol or other drug dependence, other than nicotine dependence,
• their T1 weighted brain MRI reveals gross structural abnormalities,
• they have a history of syncope.
• they are pregnant
• they are actively seeking or engaged in smoking cessation treatment.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. doi: 10.1002/med.2610020104. No abstract available.

  PMID: 6125634 BACKGROUND

• Avants SK, Margolin A, Kosten TR, Cooney NL. Differences between responders and nonresponders to cocaine cues in the laboratory. Addict Behav. 1995 Mar-Apr;20(2):215-24. doi: 10.1016/0306-4603(94)00066-2.

  PMID: 7484315 BACKGROUND

• Bandettini PA, Jesmanowicz A, Wong EC, Hyde JS. Processing strategies for time-course data sets in functional MRI of the human brain. Magn Reson Med. 1993 Aug;30(2):161-73. doi: 10.1002/mrm.1910300204.

  PMID: 8366797 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: August 6, 2002
• Study Completion: July 25, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-07-25

Locations

US (1)