Gradual vs. Abrupt Cessation Treatment for Smoking
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation |
Behavioral: Reduction Phone Counseling Behavioral: Abrupt Phone Counseling Behavioral: Minimal Abrupt Phone Counseling Drug: Pre-Quit Nicotine Lozenges Drug: Post-Quit Nicotine Lozenges |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Gradual vs. Abrupt Cessation Treatment for Smoking |
- Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
| Enrollment: | 750 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gradual reduction
Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
|
Behavioral: Reduction 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.
Drug: Pre-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. Other Name: Commit Nicotine Lozenges
Drug: Post-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. Other Name: Commit Nicotine Lozenges
|
|
Active Comparator: Abrupt cessation
Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
|
Behavioral: Abrupt 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.
Drug: Post-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. Other Name: Commit Nicotine Lozenges
|
|
Active Comparator: Minimal intervention
Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
|
Behavioral: Minimal 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.
Drug: Post-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. Other Name: Commit Nicotine Lozenges
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Vermont | |
| University of Vermont Human Behavioral Pharmacology Lab | |
| Burlington, Vermont, United States, 05401 | |
| Principal Investigator: | John Hughes, MD | University of Vermont |
More Information
Publications:
| Responsible Party: | John Hughes, Professor of Psychiatry, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT00297492 History of Changes |
| Other Study ID Numbers: | R01 DA11557-07, R01DA011557-07 |
| Study First Received: | February 24, 2006 |
| Results First Received: | May 31, 2012 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Vermont:
|
Smoking Cessation Tobacco |
Additional relevant MeSH terms:
|
Smoking Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013