Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02796391

Collaborator

James and Esther King Biomedical Research Program (Other)

163

Enrollment

Location

Arms

81.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: Very Low Nicotine Content (VLNC) Cigarettes Behavioral: One on One Counseling	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

163 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Actual Study Start Date :

Sep 7, 2017

Actual Primary Completion Date :

Apr 2, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study 1: Immediate Reduction This group will receive the lowest nicotine dose (.03 mb nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction. Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.
Experimental: Study 1: Gradual Reduction This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction). Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.
Experimental: Study 2: Targeted/Immediate Reduction This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction). Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.
Experimental: Study 2: Targeted/Gradual Reduction This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction). Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.
Experimental: Study 2: Generic/Immediate Reduction This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction). Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.
Experimental: Study 2: Generic/Gradual Reduction This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction). Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.	Drug: Very Low Nicotine Content (VLNC) Cigarettes Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm. Other Names: SPECTRUM® Research Cigarettes NOT-DA-13-002 Behavioral: One on One Counseling All participants will receive One on One Counseling.

Outcome Measures

Primary Outcome Measures

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.
Study 2 - Rate of Abstinence Success at 2 Months [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 - Rate of Abstinence Success at 6 Months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.).