Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The overall aim of this project is to evaluate the effect of progressive nicotine reduction
      in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with
      comorbid mood and/or anxiety disorders.

      Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain
      either a) nicotine content similar to their preferred usual brand of cigarettes, or b)
      nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to
      0.2 mg per cigarette over 18 weeks.

      It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine
      content in the Reduced Nicotine Content group without significant increases in tobacco smoke
      exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or
      protocol non-adherence over time in the Reduced Nicotine Content group as compared with the
      control group.
    

Detailed description: 
      The overall aim of this project is to evaluate the effect of progressive nicotine reduction
      in cigarettes on smoking behavior, toxicant exposure and psychiatric symptoms in smokers with
      comorbid mood and/or anxiety disorders.

      To do so, we will randomly assign 200 adult smokers with a unipolar mood and/or anxiety
      disorder within the past year to smoke research cigarettes that will contain either a) Usual
      Nicotine Content (UNC): nicotine content similar to their preferred usual brand of
      cigarettes, or b) Reduced Nicotine Content (RNC): nicotine content per cigarette is
      progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. All
      subjects will participate in baseline periods prior to double-blind randomization to assess
      normal smoking behavior and then to establish ability to tolerate research cigarettes prior
      to randomization.

      A total of 280 participants will be enrolled in the study at two sites with the aim of
      randomizing 200 who complete the baseline phase. 100 participants will be enrolled in the
      randomized phase at Penn State Hershey and 100 at the Massachusetts General Hospital site.
      Participants will be started on the study protocol during Baseline I and Baseline II but will
      be removed from the study if they are not able to comply with the protocol. We expect that
      approximately 40 participants at each site drop out from the study prior to randomization
      (due to inability to comply with study protocol).

      It is our hypothesis that nicotine intake, as measured by plasma cotinine concentration, will
      decline as a function of cigarette nicotine content in the RNC group. Further, it is our
      hypothesis that by gradually reducing the nicotine content of the cigarettes in a step-wise
      fashion, there will not be significant increases in biomarkers of tobacco smoke exposure,
      severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol
      non-adherence over time in the experimental group (RNC) as compared with the UNC control
      group.
    

Intervention name(s): Reduced Nicotine Content Cigarettes; Usual Nicotine Content Cigarettes
Intervention type(s): Drug; Drug
Intervention description(s): Research cigarettes will have gradually reduced nicotine content; Usual Nicotine Content Cigarettes
Other intervention name(s): Nicotine; Nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Smoking; Nicotine