Smoking Cessation
Conditions
Keywords
nicotine, cigarettes, very low nicotine content (VLNC), smoking cessation
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.
Interventions
DRUGVery 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.
BEHAVIORALOne on One Counseling
All participants will receive One on One Counseling.
Sponsors
James and Esther King Biomedical Research Program
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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. |
Countries
United States
Participant flow
Pre-assignment details
1 participant did not meet inclusion criteria in study 1 before being assigned to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Study 1: Immediate Reduction 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. | 7 |
| Study 1: Gradual Reduction Participants will receive 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. | 8 |
| Study 2: Targeted/Immediate Reduction Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). 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 counselling. | 41 |
| Study 2: Targeted/Gradual Reduction Participants will receive 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. | 32 |
| Study 2: Generic/Immediate Reduction Participants will receive 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. | 34 |
| Study 2: Generic/Gradual Reduction Participants will receive 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 | 40 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | COVID | 0 | 0 | 5 | 5 | 2 | 4 |
| Overall Study | Lost to Follow-up | 2 | 2 | 13 | 8 | 14 | 13 |
| Overall Study | Participant did not like study cigarettes | 0 | 0 | 3 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 4 | 3 | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Study 1: Gradual Reduction | Study 2: Targeted/Immediate Reduction | Study 2: Targeted/Gradual Reduction | Study 1: Immediate Reduction | Study 2: Generic/Immediate Reduction | Study 2: Generic/Gradual Reduction |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 0 Participants | 10 Participants | 3 Participants | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants | 8 Participants | 31 Participants | 29 Participants | 5 Participants | 30 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 1 Participants | 5 Participants | 6 Participants | 0 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 7 Participants | 36 Participants | 26 Participants | 7 Participants | 31 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 136 Participants | 6 Participants | 35 Participants | 28 Participants | 5 Participants | 28 Participants | 34 Participants |
| Region of Enrollment United States | 162 participants | 8 participants | 41 participants | 32 participants | 7 participants | 34 participants | 40 participants |
| Sex: Female, Male Female | 90 Participants | 3 Participants | 23 Participants | 20 Participants | 3 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Male | 72 Participants | 5 Participants | 18 Participants | 12 Participants | 4 Participants | 15 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 41 | 0 / 32 | 0 / 34 | 0 / 40 |
| other Total, other adverse events | 5 / 7 | 3 / 8 | 25 / 41 | 20 / 32 | 24 / 34 | 27 / 40 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 41 | 3 / 32 | 1 / 34 | 2 / 40 |
Outcome results
Primary
Study 1 - Rate of Participant Completion of Pilot
Pilot: Complete formative research based on 15 participants to prepare for Study 2.
Time frame: Up to 2 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1: Immediate Reduction | Study 1 - Rate of Participant Completion of Pilot | 4 Participants |
| Study 1: Gradual Reduction | Study 1 - Rate of Participant Completion of Pilot | 5 Participants |
Primary
Study 2 - Participant Abstinence Success 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.
Time frame: At 2 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study 1: Immediate Reduction | Study 2 - Participant Abstinence Success at 2 Months | 12 participants |
| Study 1: Gradual Reduction | Study 2 - Participant Abstinence Success at 2 Months | 8 participants |
| Study 2: Generic/Immediate Reduction | Study 2 - Participant Abstinence Success at 2 Months | 10 participants |
| Study 2: Generic/Gradual Reduction | Study 2 - Participant Abstinence Success at 2 Months | 13 participants |
Primary
Study 2 - Participant Abstinence Success 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.
Time frame: At 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study 1: Immediate Reduction | Study 2 - Participant Abstinence Success at 6 Months | 10 participants |
| Study 1: Gradual Reduction | Study 2 - Participant Abstinence Success at 6 Months | 7 participants |
| Study 2: Generic/Immediate Reduction | Study 2 - Participant Abstinence Success at 6 Months | 6 participants |
| Study 2: Generic/Gradual Reduction | Study 2 - Participant Abstinence Success at 6 Months | 10 participants |