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Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

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ClinicalTrials.gov Identifier: NCT01928719
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
George Washington University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center

Brief Summary:
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Reduced Nicotine Content Cigarettes Drug: Same Nicotine Content Cigarettes Not Applicable

Detailed Description:

To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.3 mg per cigarette in five 3-wk stages, or a control group with nicotine content that approximately matches the nicotine content of their usual brand of cigarettes.

Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reduced Nicotine Content Cigarettes
the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (8 [9 for menthol], 4, 1.7, 0.9 and 0.3 mg) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.
Drug: Reduced Nicotine Content Cigarettes
Cigarettes contain 8 [9 for menthol], 4, 1.7, 0.9 and 0.3 mg of nicotine
Other Name: Nicotine

Placebo Comparator: Same Nicotine Content Cigarettes
The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes approximately matching the nicotine content of their preferred brand of cigarettes (about 11.4 mg)
Drug: Same Nicotine Content Cigarettes
about 11.4 mg nicotine per cigarette
Other Name: Nicotine




Primary Outcome Measures :
  1. Adherence to a regimen of progressively lowering cigarette nicotine levels [ Time Frame: 18 weeks ]
    Number of participants who dropped out of the randomization phase compared between the experimental and control arms.


Secondary Outcome Measures :
  1. Predictors in participant dropout/relapse [ Time Frame: 18 weeks ]
    Possible predictors of dropout/relapse include smoking topography and expired carbon monoxide, a higher baseline nicotine dependence behavioral score and rapid nicotine metabolism phenotypes

  2. Changes in Cigarettes per day [ Time Frame: 18 weeks ]
    Measured by self reported cigarettes per day

  3. Changes in nicotine exposure [ Time Frame: 18 weeks ]
    Measured by cotinine (ng/ml) and 3-hydroxycotinine (ng/ml) measured in urine and blood

  4. Changes in smoke exposure [ Time Frame: 18 weeks ]
    Changes in carbon monoxide levels measured in expired CO

  5. Stress reduction --Perceived Stress Questionnaire, cortisol and amylase [ Time Frame: 18 weeks ]

    Perceived Stress Questionnaire changes from baseline; Salivary Cortisol and amylase:

    Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Salivary alpha amylase (sAA) is a marker of activity for the sympathetic nervous system and has been proposed as a sensitive biomarker for stress-related changes in the body




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65
  • Less than 16 years of education
  • Able to understand, and sign consent
  • Smoke >4 cigarettes/day for at least a year
  • No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
  • Plan to live in local area for next 8 months
  • Able to read and write in English
  • Women not pregnant and taking steps to avoid pregnancy

Exclusion Criteria:

  • College graduate
  • Use of psychotropic drugs
  • Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
  • Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
  • Currently pregnant or nursing
  • Uncontrolled serious psychotic illness or substance abuse
  • History of difficulties providing blood samples-fainting, poor veins, anxiety

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): NCT01928719


Locations
United States, District of Columbia
George Washington University School of Public Health
Washington, District of Columbia, United States, 20052
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
George Washington University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joshua Muscat, PhD Penn State College of Medicine
Study Director: Kimberly Horn, PhD George Washington University School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan Foulds, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01928719     History of Changes
Other Study ID Numbers: 43804UG-P1
P50DA036107-01 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jonathan Foulds, Milton S. Hershey Medical Center:
Smoking
Nicotine

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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