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Brain Nicotine Receptor Density & Response to Nicotine Patch

NCT01526005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2015-01-27

No results posted yet for this 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.

Conditions

  • Cigarette Smoking

Interventions

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

DRUG

Transdermal Placebo Patch

1 patch per day; 8 weeks total

Sponsors & Collaborators

  • Brentwood Biomedical Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526005 on ClinicalTrials.gov