Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Phase 2

Completed

Conditions: Smoking Cessation

Interventions: Drug: Very Low Nicotine Content (VLNC) Cigarettes
Behavioral: One on One Counseling

Registration Number: NCT02796391

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 163

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.).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study 2: Targeted/Immediate Reduction	One on One Counseling	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Generic/Immediate Reduction	One on One Counseling	Participants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Study 1: Immediate Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Targeted/Gradual Reduction	One on One Counseling	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
Study 1: Gradual Reduction	One on One Counseling	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Targeted/Immediate Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Generic/Gradual Reduction	One on One Counseling	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Study 1: Immediate Reduction	One on One Counseling	Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Targeted/Gradual Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
Study 1: Gradual Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Generic/Immediate Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Study 2: Generic/Gradual Reduction	Very Low Nicotine Content (VLNC) Cigarettes	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.

Primary Outcome Measures

Name	Time	Method
Study 2 - Participant Abstinence Success at 2 Months	At 2 Months	Participants reporting 7-day point prevalence abstinence at 2 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Study 2 - Participant Abstinence Success at 6 Months	At 6 Months	Participants reporting 7-day point prevalence abstinence at 6 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Study 1 - Rate of Participant Completion of Pilot	Up to 2 Weeks	Pilot: Complete formative research based on 15 participants to prepare for Study 2.