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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA011557-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gradual reduction | Experimental | Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. |
|
| Abrupt cessation | Active Comparator | Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. |
|
| Minimal intervention | Active Comparator | Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction Phone Counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hughes, MD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Human Behavioral Pharmacology Lab | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20537810 | Result | Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007. Epub 2010 May 26. |
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Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gradual Reduction | Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date |
| FG001 | Abrupt Cessation | Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date |
| FG002 | Minimal Intervention | Minimal intervention to mimic intervention at a primary care office |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Set Quit Date |
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| ||||||||||||||||||
| 6 Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gradual Reduction | Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date |
| BG001 | Abrupt Cessation | Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gradual Reduction | Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date |
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Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Hughes | University of Vermont | 802-656-9610 | John.Hughes@uvm.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Abrupt Phone Counseling | Behavioral | 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. |
|
| Minimal Abrupt Phone Counseling | Behavioral | 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. |
|
| Pre-Quit Nicotine Lozenges | Drug | 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. |
|
|
| Post-Quit Nicotine Lozenges | Drug | 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. |
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| NOT COMPLETED |
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| BG002 | Minimal Intervention | Minimal intervention to mimic intervention at a primary care office |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Abrupt Cessation |
Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date. |
| OG002 | Minimal Intervention | Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date. |
|
|
|
| 0 |
| 297 |
| 0 |
| 297 |
| EG001 | Abrupt Cessation | Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date | 0 | 299 | 0 | 299 |
| EG002 | Minimal Intervention | Minimal intervention to mimic intervention at a primary care office | 0 | 150 | 0 | 150 |
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