Brain Nicotine Receptor Density & Response to Nicotine Patch

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Brentwood Biomedical Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Arthur Brody, Brentwood Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01526005
First received: August 29, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Cigarette Smoking
Drug: Transdermal Nicotine Patch
Drug: Transdermal Placebo Patch
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brain Nicotine Receptor Density & Response to Nicotine Patch

Resource links provided by NLM:


Further study details as provided by Brentwood Biomedical Research Institute:

Estimated Enrollment: 50
Study Start Date: March 2012
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526005

Contacts
Contact: Arthur L Brody, M.D. 310-478-3711 ext 84778 abrody@ucla.edu

Locations
United States, California
West Los Angeles Veterans Affairs Medical Center Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Arthur L Brody, M.D.    310-478-3711 ext 84778    abrody@ucla.edu   
Sponsors and Collaborators
Brentwood Biomedical Research Institute
  More Information

No publications provided by Brentwood Biomedical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur Brody, Principal Investigator, Brentwood Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01526005     History of Changes
Other Study ID Numbers: 0015
Study First Received: August 29, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014