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Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

Phase 4
18 Years
75 Years
Not Enrolling

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Trial Information

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

The ultimate objective is to obtain information necessary to match NRT to those smokers with
the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine
nasal spray (NS) will result in significantly higher abstinence rates than transdermal
nicotine (TN) for the following subgroups of smokers: those with genotypes associated with
less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those
with higher levels of novelty-seeking, depression, and attention deficit symptoms.

Inclusion Criteria:

- The subjects will be male and female smokers age 18-75.

- Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

- Planning a pregnancy, pregnant, or lactating

- Current addiction to opiates, cocaine, or stimulants

- Skin allergies or chronic dermatitis (based on medical history/self-report)

- An Axis 1 major psychiatric disorder

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)

Outcome Description:

A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).

Outcome Time Frame:

End of Treatment (8-weeks after quit date)

Safety Issue:


Principal Investigator

Caryn Lerman, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

December 1999

Completion Date:

August 2004

Related Keywords:

  • Smoking
  • Nicotine nasal spray + counseling
  • Transdermal nicotine + counseling
  • Smoking



University of Pennsylvania Philadelphia, Pennsylvania  19104