SmokingQUITSNCT02168855
Cessation in Non-Daily Smokers
A study testing active nicotine gum and Standard behavioral therapy in people with Smoking, run by Brian Primack at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- active nicotine gum and Standard behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Smoking for at least 3 years
- Smoking non-daily for at least one year (< or = 27 days/month)
- Smoke at least weekly
- Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
- Willing and able to come to the laboratory for 8 visits over a 14-week period, as well as a ninth and final visit 6 months after their quit date
- Willing to monitor behavior via an electronic diary for 8 weeks
- Able to read and write English (in order to understand questionnaires and study instructions)
Who cannot join
- Regular use of any form of tobacco other than cigarettes
- Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
- Night and/or 'swing' shift work (which complicates EMA schedules)
- Known plans to relocate or move from the Pittsburgh area within the coming 6 months
- Received cessation treatment within past year
- Use of bupropion or varenicline in past 2 months
Show all 10Show fewer
- Past use of nicotine gum (to avoid un-blinding)
- Contraindication to NRT
- (for women) Current pregnancy or breastfeeding or plan to become pregnant during the next 2 months
- Member of the same household already participating
Trial locations and contacts
1 site in 1 country.
United States1 site
Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).
Read the detailed description
Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and long term abstinence will be assessed and biochemically validated. EMA data collection includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data. This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns.
- Conditions
- Smoking
- Being tested
- active nicotine gum, Standard behavioral therapy
- Keywords
- Smoking cessation, Non-daily smokers, Ecological Momentary Assessment, nicotine replacement therapy
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active nicotine gumDrug
2 mg, standard over-the-counter nicotine replacement therapy gum
Standard behavioral therapyBehavioural
Standard behavioral therapy for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Active nicotine gum | Active comparator | Not described Receives: Drug: active nicotine gum; Behavioral: Standard behavioral therapy |
| Inactive gum | Placebo comparator | Not described Receives: Behavioral: Standard behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation, Continuous 6-month Abstinence
Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.
Measured: up to week 24
Secondary outcomes (4)
Characteristics of Quit and Relapse Process - Craving
Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assessed the intensity of craving experienced by participants during their attempt to quit smoking, via self-report. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.
The scale's range was 0-100, with higher values reflecting higher levels of self-reported craving (maximum score of 100), whereas a score of 0 indicates no craving. "Background" craving is defined as that experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.
Measured: Six-week post-quit period
Characteristics of Quit and Relapse Process - Negative Affect
Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assesses the intensity of negative affect participants experienced during their attempt to quit smoking. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.
The scale's range was 0-100, with higher values reflecting higher levels of self-reported negative affect (maximum score of 100), whereas a score of 0 would indicate no negative affect. 50 indicates the population mean with a standard deviation of 10. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.
Measured: Six-week post-quit period
Characteristics of Quit and Relapse Process - Saw No Smoking Cues
Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns.To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.
This measure reports the percentage of instances during which participants were not exposed to physical cues to smoke, such as cigarettes, ashtrays, or lighters), when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.
Measured: Six-week post-quit period
Characteristics of Quit and Relapse Process - No Others Smoking Nearby
Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.
This measure reports the percentage of instances during which participants were not exposed to others smoking nearby, when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.
Measured: Six-week post-quit period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2019
- Study completionJan 2019
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.
- Other trials for SmokingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Primack
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Brian Primack, University of Pittsburgh
- Investigators
- Brian A Primack, MD, PhD, Principal investigator, University of Pittsburgh, Division of General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168855
- Sponsor's protocol ID
- 1R01DA034629
- Acronym
- QUITS
- Status last verified
- Apr 2020
- First submitted
- 18 Jun 2014
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT02168855
- Acronym / sponsor ID
- QUITS / 1R01DA034629
- Conditions
- Smoking
- Keywords
- Smoking cessation, Non-daily smokers, Ecological Momentary Assessment, nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Brian PrimackUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 6 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).
Detailed description
Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and long term abstinence will be assessed and biochemically validated. EMA data collection includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data. This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active nicotine gum | Active comparator | Drug: active nicotine gum, Behavioral: Standard behavioral therapy |
| Inactive gum | Placebo comparator | Behavioral: Standard behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old or older
- Smoking for at least 3 years
- Smoking non-daily for at least one year (< or = 27 days/month)
- Smoke at least weekly
- Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
Key exclusion criteria (10 listed)
- Regular use of any form of tobacco other than cigarettes
- Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
- Night and/or 'swing' shift work (which complicates EMA schedules)
- Known plans to relocate or move from the Pittsburgh area within the coming 6 months
- Received cessation treatment within past year
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 |
|---|---|---|
| active nicotine gum2 mg, standard over-the-counter nicotine replacement therapy gum | Drug | Active nicotine gum |
| Standard behavioral therapyStandard behavioral therapy for smoking cessation | Behavioural | Active nicotine gum, Inactive gum |
Primary outcome
Smoking Cessation, Continuous 6-month Abstinence
Time frame: up to week 24
Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.
4 secondary outcomes
Characteristics of Quit and Relapse Process - Craving
Time frame: Six-week post-quit period
Characteristics of Quit and Relapse Process - Negative Affect
Time frame: Six-week post-quit period
Characteristics of Quit and Relapse Process - Saw No Smoking Cues
Time frame: Six-week post-quit period
Characteristics of Quit and Relapse Process - No Others Smoking Nearby
Time frame: Six-week post-quit period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian A Primack, MD, PhD principal investigator
University of Pittsburgh, Division of General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active nicotine gum and Standard behavioral therapy in people with Smoking, run by Brian Primack 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 8 inclusion and 10 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 6 May 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2020). 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?
Smoking Cessation, Continuous 6-month Abstinence (time frame: up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.