Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this research study is to:
- compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
- identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
674 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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