Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2

Tobacco Use Disorder Clinical Trial

Official title:

Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135746
• Other study ID #: NIDA-11082-2
• Secondary ID: R01-11082-2DPMC
• Status: Completed
• Phase: N/A
• First received: August 23, 2005
• Last updated: January 11, 2017
• Start date: May 2004
• Est. completion date: June 2007

Study information

• Verified date: October 2015
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays on the effectiveness of nicotine replacement therapy. This may lead to improved cessation interventions for all smokers, particularly women.

Description:

Currently, about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, such as the taste, sight, and smell of smoke. Tailoring treatment to the separate needs of subgroups, such as men and women, may produce better outcomes. The purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers.

Participants in this double-blind, dose-comparison study will complete separate sessions in a random order.

Each session will last approximately 6.5 hours and will correspond to a specific transdermal patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. Cognitive, behavioral, subjective, and physiological measures will occur during study visits. Specifically, the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Daily cigarette use of 15 or more cigarettes for at least 2 years

• Screening CO level of or greater than 15 ppm

• Normal or corrected-to-normal vision

• Willing to abstain from tobacco products for 8 or more hours prior to testing

Exclusion Criteria:

• History of chronic health problems or psychiatric conditions

• History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes

• Pregnancy (tested by urinalysis)

• Scores greater than 17 on the Beck Depression Inventory

• Lack of a high school degree or GED

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• nicotine transdermal system

Locations

Country	Name	City	State
United States	Behavioral Pharmacolgy Research Laboratory	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective effects
Primary	Cognitive performance
Primary	Physiologic measures
Primary	Smoking Behavior
Primary	Plasma Nicotine