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Cessation in Non-Daily Smokers (QUITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168855
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brian Primack, University of Pittsburgh

Brief 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).

Condition or disease Intervention/treatment Phase
Smoking Drug: active nicotine gum Behavioral: Standard behavioral therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cessation in Non-Daily Smokers: A RCT of NRT With Ecological Momentary Assessment
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active nicotine gum Drug: active nicotine gum
2 mg, standard over-the-counter nicotine replacement therapy gum

Behavioral: Standard behavioral therapy
Standard behavioral therapy for smoking cessation

Placebo Comparator: Inactive gum Behavioral: Standard behavioral therapy
Standard behavioral therapy for smoking cessation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Characteristics of Quit and Relapse Process - Craving [ Time Frame: Six-week post-quit period ]

    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.


  2. Characteristics of Quit and Relapse Process - Negative Affect [ Time Frame: Six-week post-quit period ]

    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.


  3. Characteristics of Quit and Relapse Process - Saw No Smoking Cues [ Time Frame: Six-week post-quit period ]

    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.


  4. Characteristics of Quit and Relapse Process - No Others Smoking Nearby [ Time Frame: Six-week post-quit period ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168855


Locations
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United States, Pennsylvania
Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Brian Primack
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Brian A Primack, MD, PhD University of Pittsburgh, Division of General Internal Medicine
  Study Documents (Full-Text)

Documents provided by Brian Primack, University of Pittsburgh:
Statistical Analysis Plan  [PDF] January 8, 2019
Study Protocol  [PDF] June 2, 2016

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Responsible Party: Brian Primack, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02168855    
Other Study ID Numbers: 1R01DA034629 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2014    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020
Keywords provided by Brian Primack, University of Pittsburgh:
Smoking cessation
Non-daily smokers
Ecological Momentary Assessment
nicotine replacement therapy
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action