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Changing the Default for Tobacco Treatment

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: NCT02721082
Recruitment Status : Enrolling by invitation
First Posted : March 28, 2016
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Opt Out Treatment Program Drug: Nicotine Replacement Therapy Behavioral: Opt In Treatment Program Phase 4

Detailed Description:

In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.

For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.

This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Changing the Default for Tobacco Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out". Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Behavioral: Opt Out Treatment Program
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.

Drug: Nicotine Replacement Therapy
Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Other Names:
  • Nicotine patch
  • Nicotine mini-lozenges
  • Nicotine gum

Active Comparator: Opt In
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
Behavioral: Opt In Treatment Program
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.

Drug: Nicotine Replacement Therapy
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Other Names:
  • Nicotine patch
  • Nicotine mini-lozenges
  • Nicotine gum




Primary Outcome Measures :
  1. 7-day point-prevalence abstinence [ Time Frame: 1 month ]
    7-day, self-reported and verified cigarette abstinence at 1 month after enrollment. Will be measured via salivary cotinine or expired carbon monoxide to confirm smoking status.


Secondary Outcome Measures :
  1. Cost of counseling [ Time Frame: Month 1 ]
    Cost of counseling will be calculated based on total counseling time

  2. Number of days of medication use [ Time Frame: 6 months ]
    Measured as an aggregate of the type, dose and number of days medication was used

  3. Total intervention cost [ Time Frame: 6 months ]
    Calculation for cost will include inpatient counselor services, quit line counselor time and medication given to participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Speak English or Spanish
  • Have access to a telephone or mobile phone
  • Not be currently pregnant or breast feeding
  • Have no significant co-morbidity that precludes participation
  • Current daily smoker
  • Not in treatment for tobacco dependence
  • Reside in Kansas or Missouri

Exclusion Criteria:

  • Admission greater than 3 days

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): NCT02721082


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Kimber Richter, PhD University of Kansas Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02721082    
Other Study ID Numbers: STUDY00001774
R01HL131512 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Kansas Medical Center:
tobacco treatment
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