Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: James and Esther King Biomedical Research Program
• Treatments: Nicotine

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.).