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Completed

NCT Number: NCT01928719

Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University School of Public Health, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced Nicotine Content Cigarettes

Drug

Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette

Other names: Nicotine

Same Nicotine Content Cigarettes

Drug

about 11.6 mg nicotine per cigarette

Other names: Nicotine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • George Washington University
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2013
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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