Smoking CessationPhase 2NCT00297492
Gradual vs. Abrupt Cessation Treatment for Smoking
A Phase 2 study testing Reduction Phone Counseling, Abrupt Phone Counseling and Minimal Abrupt Phone Counseling in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Reduction Phone Counseling, Abrupt Phone Counseling and Minimal Abrupt Phone Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Human Behavioral Pharmacology Lab
Burlington, Vermont, 05401
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Reduction Phone Counseling, Abrupt Phone Counseling, Minimal Abrupt Phone Counseling, Pre-Quit Nicotine Lozenges, Post-Quit Nicotine Lozenges
- Keywords
- Smoking Cessation, Tobacco
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction Phone CounselingBehavioural
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.
Abrupt Phone CounselingBehavioural
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 CounselingBehavioural
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 LozengesDrug
Also called Commit 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.
Post-Quit Nicotine LozengesDrug
Also called Commit 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.
| Study group | Role | What they receive |
|---|---|---|
| Gradual reduction | Experimental | Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. Receives: Behavioral: Reduction Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges |
| Abrupt cessation | Active comparator | Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. Receives: Behavioral: Abrupt Phone Counseling; Drug: Post-Quit Nicotine Lozenges |
| Minimal intervention | Active comparator | Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. Receives: Behavioral: Minimal Abrupt Phone Counseling; Drug: Post-Quit Nicotine Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, John Hughes, University of Vermont
- Investigators
- John Hughes, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297492
- Sponsor's protocol ID
- R01DA011557-07
- Other IDs
- R01DA011557-07
- Status last verified
- Sep 2013
- First submitted
- 24 Feb 2006
- Last updated
- 20 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20537810
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradual vs. Abrupt Cessation Treatment for Smoking
- ClinicalTrials.gov ID
- NCT00297492
- Acronym / sponsor ID
- R01DA011557-07
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gradual reduction | Experimental | Behavioral: Reduction Phone Counseling, Drug: Pre-Quit Nicotine Lozenges, Drug: Post-Quit Nicotine LozengesIntervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. |
| Abrupt cessation | Active comparator | Behavioral: Abrupt Phone Counseling, Drug: Post-Quit Nicotine LozengesIntervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. |
| Minimal intervention | Active comparator | Behavioral: Minimal Abrupt Phone Counseling, Drug: Post-Quit Nicotine LozengesIntervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- Women who are pregnant or breastfeeding
- Currently using medication for depression or asthma
- Heart disease requiring medication
- Heart attack in last month
- Irregular heartbeat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction Phone CounselingCounseling 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. | Behavioural | Gradual reduction |
| Abrupt Phone CounselingCounseling 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. | Behavioural | Abrupt cessation |
| Minimal Abrupt Phone CounselingMinimal 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. | Behavioural | Minimal intervention |
| Pre-Quit Nicotine LozengesAlso: Commit Nicotine Lozenges2 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. | Drug | Gradual reduction |
| Post-Quit Nicotine LozengesAlso: Commit Nicotine Lozenges2 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. | Drug | Abrupt cessation, Gradual reduction, Minimal intervention |
Primary outcome
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20537810Hughes 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hughes, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduction Phone Counseling, Abrupt Phone Counseling and Minimal Abrupt Phone Counseling in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.