Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

NCT00390559 | Completed Results

• 3 other identifiers: NIDA-11082-3R01DA011082R01-11082-3 DPMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.

Conditions

Drug Addiction; Smoking Cessation

Keywords

Nicotine Replacement Therapy; Tobacco Smoking; Smoking stimuli; Gender

Outcome Measures

Primary Outcomes (1)

• Subjective Effects

  The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").

  6 hours

Study Arms (4)

ActiveP/ActiveC

EXPERIMENTAL

21 mg patch/Nicotine-containing cigarette

Drug: nicotine transdermal system; Other: Nicotine containing cigarette

PlaceboP/ActiveC

EXPERIMENTAL

0 mg patch/nicotine-containing cigarette

Drug: Nicotine transdermal system; Other: Nicotine containing cigarette

Active P/PlaceboC

EXPERIMENTAL

21 mg patch/no nicotine cigarette

Drug: nicotine transdermal system; Other: Placebo cigarette

PlaceboP/PlaceboC

EXPERIMENTAL

0 mg patch/no nicotine cigarette

Drug: Nicotine transdermal system; Other: Placebo cigarette

Interventions

Nicotine transdermal system DRUG

21 mg nicotine transdermal system

Also known as: Nicoderm CQ

Active P/PlaceboC; ActiveP/ActiveC

Nicotine containing cigarette OTHER

Nicotine containing cigarette

ActiveP/ActiveC; PlaceboP/ActiveC

Placebo cigarette OTHER

Non nicotine containing cigarette

Active P/PlaceboC; PlaceboP/PlaceboC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University - Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Smoking Cessation; Tobacco Smoking; Coitus

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Smoking; Tobacco Use; Sexual Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Thomas Eissenberg
• Organization: Virginia Commonwealth University

teissenb@vcu.edu

804.827.4617

Study Officials

• Thomas E Eissenberg, PhD

  Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 20, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 18, 2012
• Results First Posted: July 18, 2012

Record last verified: 2012-07

Locations

US (1)