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CompletedNCT01526005Updated Jan 27, 2015

Brain Nicotine Receptor Density & Response to Nicotine Patch

An observational study in Cigarette Smoking, sponsored by Brentwood Biomedical Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Brentwood Biomedical Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Cigarette Smoking

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In context

Cigarette Smoking

132 studies on the registry are indexed under Cigarette Smoking; 60 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 17 observational studies indexed under Cigarette Smoking.

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Lead sponsor

Brentwood Biomedical Research Institute is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • Active agent (nicotine patch)

    Drug: Transdermal Nicotine Patch

  • Placebo patch

    Drug: Transdermal Placebo Patch

Interventions

  • 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

  • DrugTransdermal Placebo Patch

    1 patch per day; 8 weeks total

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What researchers measure

Primary outcomes

  1. PET scanning

    Brain imaging used to predict response to smoking cessation treatment

    Time frame: 2/12-2/14

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Study locations

1 site
  • West Los Angeles Veterans Affairs Medical Center
    Los Angeles, California 90073, United States
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References and documents

Publications

  • Brody AL, Mukhin AG, Mamoun MS, Luu T, Neary M, Liang L, Shieh J, Sugar CA, Rose JE, Mandelkern MA. Brain nicotinic acetylcholine receptor availability and response to smoking cessation treatment: a randomized trial. JAMA Psychiatry. 2014 Jul 1;71(7):797-805. doi: 10.1001/jamapsychiatry.2014.138. PubMed 24850280 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01526005
Lead sponsor
Brentwood Biomedical Research Institute
Responsible party
Arthur Brody (Principal Investigator, Brentwood Biomedical Research Institute) — Principal investigator
First posted
Feb 3, 2012
Start date
Mar 2012
Primary completion
Jan 2014
Last update
Jan 27, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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