Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol); denicotinized cigarettes (Quest 3 cigarettes)
Intervention description: Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.; Cigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: gender; nicotine dependence; nicotine replacement therapy; extinction; denicotinized cigarettes

Summary:

      This study will investigate the underlying neurobiology of differences between male and
      female smokers. Research suggests that women are less responsive to nicotine replacement
      therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking.
      This study proposed that male smokers will have a greater response to NRT demonstrated by
      reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional
      magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues
      as compared to female smokers treated with NRT. Additionally, female smokers will have a
      greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and
      less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21 - 60.

          2. Meet criteria for primary nicotine dependence, smoke at least 70% of days in the last
             30 days prior to assessment.

          3. Participants will have afternoon end-expired carbon monoxide levels of at least 15
             p.p.m. to confirm smoke inhalation.

          4. Moderate to high levels of nicotine dependence confirmed by Fagerstrom Test of
             Nicotine Dependence score.

          5. General good health confirmed by history & physical, serum chemistries, complete blood
             count, urinalysis, and electrocardiogram.

          6. Able to read and understand questionnaires and informed consent.

          7. Right-handed.

          8. Treatment seeking.

          9. Demonstrate subjective response to cues in a laboratory cue reactivity session.

         10. Able to maintain abstinence from nicotine during the study period.

         11. Participants must have a negative rapid-screening Urine Drug Screen (UDS) and
             pregnancy test prior to both imaging sessions and placement of the patch.

         12. Female participants will use a reliable method of birth control throughout the study.

        Exclusion Criteria:

          1. Currently meets Diagnostic and Statistical Manual (DSM)-IV criteria for any other
             psychoactive substance dependence disorder except nicotine dependence.

          2. Any psychoactive substance abuse within the last 30 days as evidenced by subject
             report or urine drug screen.

          3. Use of other tobacco products.

          4. Current use of nicotine replacement therapy or other smoking cessation treatment.

          5. Meets DSM-IV criteria for current axis I disorders of major depression, panic
             disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar
             affective disorder, schizophrenia, or any other psychotic disorder or organic mental
             disorder. The rationale for excluding them is that symptoms from these disorders may
             affect dependent variables and complicate interpretation of the data.

          6. Current suicidal ideation with plan or homicidal ideation.

          7. Need for maintenance or acute treatment with any psychoactive medication including
             antiseizure medications.

          8. Clinically significant medical problems such as cardiovascular, renal, GI, or
             endocrine problem that would impair participation or limit ability to participate in
             scan.

          9. Sexually active females of child-bearing potential who are pregnant (by urine HCG),
             nursing, or who are not using a reliable form of birth control.

         10. Has current charges pending for a violent crime (not including Drive Under Influence
             (DUI) related offenses).

         11. Persons with ferrous metal implants or pacemaker since fMRI will be used.

         12. Persons who live with another smoker who is unwilling or unable to refrain from
             smoking in the home or presence of the participant.