Smoking Cessation
Conditions
Keywords
Smoking Cessation, Tobacco
Brief summary
This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.
Detailed description
For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the next 30 days to one of three groups: gradual reduction, abrupt cessation, and minimal intervention.
Interventions
BEHAVIORALReduction Phone Counseling
Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.
BEHAVIORALAbrupt Phone Counseling
Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
BEHAVIORALMinimal Abrupt Phone Counseling
Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.
DRUGPre-Quit Nicotine Lozenges
2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking. 4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking. Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke.
DRUGPost-Quit Nicotine Lozenges
2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking. 4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking. Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Interested in quitting gradually * At least 18 years old * Daily cigarette smoker * Smoke at least 15 cigarettes per day (CPD) * No change greater than 20% in CPD in the last month * Interested in quitting in next 30 days * Must agree to not use non-cigarette tobacco during study * No use of smoking cessation medication in last month * Have phone with voice mail * Willing to use nicotine lozenge * No other person in household in study * Fluent/literate in English
Exclusion criteria
* Women who are pregnant or breastfeeding * Currently using medication for depression or asthma * Heart disease requiring medication * Heart attack in last month * Irregular heartbeat * High blood pressure not controlled by medication * Stomach ulcers * Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement | 6 months | Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million |
Countries
United States
Participant flow
Recruitment details
Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.
Pre-assignment details
Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Gradual Reduction Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date | 297 |
| Abrupt Cessation Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date | 299 |
| Minimal Intervention Minimal intervention to mimic intervention at a primary care office | 150 |
| Total | 746 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 6 Month Follow-up | Lost to Follow-up | 63 | 49 | 27 |
| Set Quit Date | Lost to Follow-up | 7 | 13 | 5 |
Baseline characteristics
| Characteristic | Minimal Intervention | Gradual Reduction | Total | Abrupt Cessation |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 24 Participants | 58 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants | 273 Participants | 688 Participants | 276 Participants |
| Age Continuous | 47 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 13 | 48 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 150 participants | 297 participants | 746 participants | 299 participants |
| Sex: Female, Male Female | 80 Participants | 159 Participants | 404 Participants | 165 Participants |
| Sex: Female, Male Male | 70 Participants | 138 Participants | 342 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 297 | 0 / 299 | 0 / 150 |
| serious Total, serious adverse events | 0 / 297 | 0 / 299 | 0 / 150 |
Outcome results
Primary
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million
Time frame: 6 months
Population: This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gradual Reduction | Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement | 12 participants |
| Abrupt Cessation | Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement | 20 participants |
| Minimal Intervention | Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement | 7 participants |
Comparison: Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05.p-value: 0.3Chi-squared
95% CI: [0.28, 1.22]