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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

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: NCT01928719
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : March 12, 2019
Last Update Posted : May 1, 2019
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 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred 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.

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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) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) 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 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
Other Name: Nicotine

Placebo Comparator: Same Nicotine Content Cigarettes
The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)
Drug: Same Nicotine Content Cigarettes
about 11.6 mg nicotine per cigarette
Other Name: Nicotine




Primary Outcome Measures :
  1. Number of Participants Who Dropped Out of Study as a Measure of Adherence [ Time Frame: 18 weeks ]
    Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.


Secondary Outcome Measures :
  1. Predictors of Participant Dropout [ Time Frame: 18 weeks ]
    Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome.

  2. Cigarettes Per Day [ Time Frame: 18 weeks ]
    Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back

  3. Nicotine Exposure [ Time Frame: 18 weeks ]
    Measured by cotinine (ng/ml) measured in plasma

  4. Smoke Exposure [ Time Frame: 18 weeks ]
    Measured in carbon monoxide levels by expired CO

  5. Perceived Stress [ Time Frame: 18 weeks ]
    Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress.

  6. Cortisol [ Time Frame: 15 weeks ]
    Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used.



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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
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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
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Principal Investigator: Joshua Muscat, PhD Penn State College of Medicine
Study Director: Kimberly Horn, PhD George Washington University School of Public Health
  Study Documents (Full-Text)

Documents provided by Jonathan Foulds, Milton S. Hershey Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Foulds, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01928719    
Other Study ID Numbers: 43804UG-P1
P50DA036107-01 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2013    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
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:
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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