Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
Condition: Smoking Cessation
Intervention: Very Low Nicotine Content (VLNC) Cigarettes; One on One Counseling
Intervention description: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.; All participants will receive One on One Counseling.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine; cigarettes; very low nicotine content (VLNC); smoking cessation

Summary:

      STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to
      help people stop smoking by using very low nicotine content (VLNC) cigarettes. This
      developmental pilot study (n=20) will determine the feasibility of the treatment approach and
      methodology using a targeted intervention, and lead to refinements for a subsequent
      randomized controlled trial (RCT).

      STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if a targeted
      intervention will help people to stop or reduce smoking better than a standard intervention
      using very low nicotine content (VLNC) cigarettes, and to determine the optimal nicotine
      tapering schedule (gradual vs. immediate) during a 5-week pre-quit period. About 208
      participants will take part in this phase of the study at Moffitt Cancer Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoke at least 5 cigarettes daily for the past year

          -  expired-air carbon monoxide (CO) > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)

          -  current motivation to quit smoking

          -  able to speak and read English sufficiently for completion of consent form and
             questionnaires

          -  18 years of age or older

        Exclusion Criteria:

          -  pregnant or breastfeeding

          -  significant unstable medical/psychiatric or substance use disorders, or
             medically/psychiatrically at risk in the judgment of the study physician or principal
             investigator (PI)

          -  positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates,
             amphetamines, methamphetamines, or PCP (NOTES: THC will be tested but will not be an
             exclusionary criterion; participants with valid prescriptions for opiates,
             benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
             participants failing the toxicology screen will be allowed to re-screen once)

          -  breath alcohol level > 0.01 (one re-screen allowed)

          -  binge alcohol drinking (4/5 [female/male] drinks per day more than 9 days in the past
             month)

          -  systolic/diastolic blood pressure (BP) greater than or equal to 160/100, or below
             90/50 (one re-screen allowed)

          -  heart rate greater than or equal to 105 beats per minute (bpm), or below 45 bpm (one
             re-screen allowed)

          -  ever used reduced nicotine cigarettes

          -  smoke 'roll your own' cigarettes exclusively

          -  used smoking cessation medications within the past three months

          -  are currently enrolled in a smoking cessation program

          -  actively trying to quit

          -  used other tobacco products (including e-cigarettes more than 9 days in the past month

          -  currently taking the following medications: Phenytoin [Brand Name: Dilantin];
             Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]; Oxcarbazepine [Brand
             Name: Trileptal]; Primidone [Brand Name: Mysoline]; Phenobarbital; Bendamustine
             (Treanda); Clopidogrel (Plavix); Clozapine (Clozaril, FazaClo); Erlotinib (Tarceva);
             Flecainide (Tambocor); Fluvoxamine (Luvox); Irinotecan (Camptosar); Olanzapine
             (Zyprexa); Ropinirole (Requip); Tacrine (Cognex); Theophylline (Theo Dur, etc.).