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Clinical Trial 18671

Cancer Type: Healthy Subjects
Study Type: Prevention
NCT#: NCT02796391

Phase: N/A
Prinicipal Investigator: Vani Simmons

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Study Title

Facilitating Smoking Cessation with Reduced Nicotine Cigarettes


The purpose of this study is to see if targeted interventions will help people to stop or reduce smoking better than standard interventions using very low nicotine content (VLNC) cigarettes. This developmental pilot study (n=20) will determine the feasibility of the treatment approach and methodology, and lead to refinements for a subsequent randomized controlled trial (RCT).


Cigarette smoking remains the top avoidable cause of death in Florida, while approximately 18% of Floridian adults continue to smoke. As long-term cessation rates with even the most intensive interventions rarely exceed 20-30%, it is vital that research develop and validate novel methods for effective smoking cessation. It has long been understood that nicotine is the primary constituent in tobacco smoke that maintains addiction. Although the Food and Drug Administration (FDA) may place limits on the allowable nicotine levels within cigarettes, such regulatory actions will likely entail a lengthy and complex legal process. In the interim, the availability (via the NIDA Drug Supply Program) of very low nicotine content (VLNC) cigarettes represents a unique opportunity to examine the efficacy of these cigarettes for smoking cessation. The proposed research will develop and evaluate an integrated (behavioral and pharmacological) intervention targeted to maximize the efficacy of VLNC cigarettes as a smoking cessation strategy. The aims of this theory-driven intervention are as follows: Specific Aim 1: Systematically adapt a strategy that maximizes extinction to nicotine-reinforced smoking behavior via smoking VLNC cigarettes prior to cessation. This aim will draw upon existing basic and clinical literature regarding extinction processes, and employ qualitative methods (e.g., expert/consultant review, in-depth interviews) to develop and refine the intervention. As part of this aim, a developmental pilot study (n=20) will determine the feasibility of the treatment approach and methodology, and lead to refinements for a subsequent randomized controlled trial (RCT). Specific Aim 2: Examine effects of the targeted intervention, along with two tapering schedules for transition to VLNC cigarettes (immediate vs. gradual), on smoking cessation outcomes through the RCT. Specific Aim 3: Examine intervention effects on two proximal (intermediate) tests of smoking behavior. Towards this end, two behavioral paradigms will be administered to RCT participants. Specific Aim 4: Explore several potential moderators and mediators of smoking-related outcomes. Exploratory analyses will examine the potential moderators and mediators of treatment efficacy, for use in future research and applied settings. We hypothesize that smokers who receive the targeted intervention will demonstrate favorable cessation outcomes and reduced proximal smoking, relative to those who receive a standard intervention. Furthermore, we expect favorable outcomes among those who transition immediately to VLNC cigarettes during the pre-quit period, relative to those who transition gradually (based on greater opportunities for non-reinforced smoking; i.e., extinction).




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.).

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