Brain Nicotine Receptor Density & Response to Nicotine Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526005
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
Arthur Brody, Brentwood Biomedical Research Institute

Brief Summary:
Even though the health risks and societal costs of cigarette smoking are well-known, roughly 19.8% of American adults continue to smoke. While most smokers endorse a desire to quit, very few (< 5%) will actually quit in a given year without treatment, and only about 20-25% achieve abstinence after 6 months or more of effective treatment. Therefore, there continues to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current first-line medications for Tobacco Dependence include nicotine replacement therapies (such as the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion HCl (Zyban), with the current standard of care in most treatment settings being to choose specific medications based primarily on availability, ease of use, and patient preference. The goal of the proposed research is to improve the delivery of smoking cessation treatment by determining if pre-treatment nicotine receptor density in cigarette smokers is associated with smoking cessation outcome with the standard nicotine patch taper. The study's main hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine receptors will have a greater likelihood of quitting smoking from a standard course of nicotine patch treatment than smokers with more up-regulation of these receptors. Positron emission tomography (PET) will be used to test this hypothesis.

Condition or disease Intervention/treatment
Cigarette Smoking Drug: Transdermal Nicotine Patch Drug: Transdermal Placebo Patch

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brain Nicotine Receptor Density & Response to Nicotine Patch
Study Start Date : March 2012
Actual Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Active agent (nicotine patch) Drug: Transdermal Nicotine Patch
1 patch per day; dosages of 21 mg/day for 4 weeks, 14 mg/day for 2 weeks, and 7 mg/day for 2 weeks; 8 weeks total

Placebo patch Drug: Transdermal Placebo Patch
1 patch per day; 8 weeks total

Primary Outcome Measures :
  1. PET scanning [ Time Frame: 2/12-2/14 ]
    Brain imaging used to predict response to smoking cessation treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Tobacco dependent cigarette smokers will be recruited through newspaper and internet advertisements from populations living in the counties surrounding the West Los Angeles Veterans Affairs Medical Center.

Inclusion Criteria:

  • Healthy adult who is a tobacco dependent smoker (smokes 10-30 cigarettes per day) meeting criteria for Nicotine Dependence as defined by DSM-IV criteria
  • Has the desire to quit smoking
  • Ability to read, write, and give voluntary informed consent
  • An exhaled CO greater than or equal to 8 ppm during the study screening visit to verify smoking status

Exclusion Criteria:

  • Any history of an Axis I psychiatric diagnosis other than Nicotine Dependence (including other substance abuse/dependence and mood, anxiety, and psychotic disorders)
  • Any current medication or any history of a medical condition that might affect the central nervous system at the time of scanning (e.g., current treatment with a psychotropic medication, or history of severe head trauma or epilepsy).
  • Unstable cardiovascular disease, liver disease, or renal insufficiency. Routine history and physical examination will be performed at the initial screening visit to insure that participants meet study criteria
  • Pregnancy (urine pregnancy tests will be obtained on all women of child-bearing potential) due to the theoretical risk of radiation exposure to the fetus. Pre-menopausal women will only be scanned during the early follicular phase (by participant report) of the menstrual cycle because hormonal levels have been shown to affect nicotine metabolism.
  • Caffeine dependence, as evidenced by withdrawal symptoms temporally associated with caffeine ingestion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526005

United States, California
West Los Angeles Veterans Affairs Medical Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
Brentwood Biomedical Research Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arthur Brody, Principal Investigator, Brentwood Biomedical Research Institute Identifier: NCT01526005     History of Changes
Other Study ID Numbers: 0015
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action