Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
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.
The current project will (1) develop a theory-based, user-friendly, and efficient set of
 targeted cessation materials to facilitate extinction during pre-quit VLNC smoking, (2)
 establish the feasibility of recruitment and measurement strategies to be used in the RCT,
 (3) determine whether immediate vs. gradual pre-quit nicotine tapering in combination with
 the targeted behavioral intervention has beneficial effects (on cessation-related and
 intermediate outcomes) for eventual comparison with validated cessation methods (e.g., NRT),
 and (4) examine several potential moderators and mediators of treatment efficacy.
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.).