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Trial record 1 of 1 for:    Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
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Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01928719
First Posted: August 27, 2013
Last Update Posted: July 2, 2017
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.
Collaborators:
George Washington University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center
  Purpose
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 Intervention
Tobacco Dependence Drug: Reduced Nicotine Content Cigarettes Drug: Same Nicotine Content Cigarettes

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jonathan Foulds, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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:
  • 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

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

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

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

  • 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



Estimated Enrollment: 400
Study Start Date: September 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, D.C., 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
  More Information

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 Submitted: August 21, 2013
First Posted: August 27, 2013
Last Update Posted: July 2, 2017
Last Verified: June 2017
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