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Trial record 3 of 10 for:    anatabine

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

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: NCT02244918
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine Replacement Therapy Behavioral: Smoking Cessation Counseling Phase 4

Detailed Description:

Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites.

Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others.

Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
Study Start Date : May 2015
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Counseling
Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.
Behavioral: Smoking Cessation Counseling
Experimental: Counseling Plus NRT
Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.
Drug: Nicotine Replacement Therapy
Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

Behavioral: Smoking Cessation Counseling



Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: Week 12 ]
    Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.


Secondary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: Week 26 ]
    Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.

  2. Concentration of Urinary Cotinine [ Time Frame: Weeks 0, 26 ]
    Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.

  3. Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) [ Time Frame: Weeks 0, 12 ]
    Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.

  4. Total Days Abstinent [ Time Frame: Week 0-26 ]
    Number of days abstinent from baseline through week 26.

  5. Cigarettes Used [ Time Frame: Weeks 0-26 ]
    Cigarettes used in the past 30 days from baseline through week 26



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:   Yes
Criteria

Inclusion Criteria:

  • African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening

Exclusion Criteria:

  • Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

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): NCT02244918


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Swope Health Central
Kansas City, Missouri, United States, 64130
Sponsors and Collaborators
University of Kansas Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Nikki Nollen, PhD University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by 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: NCT02244918     History of Changes
Other Study ID Numbers: STUDY00001602
AD-1310-08709 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: September 19, 2014    Key Record Dates
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019
Last Verified: December 2018

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