Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

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.).