search
Back to results

Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced Nicotine Content Cigarettes
Same Nicotine Content Cigarettes
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Dependence focused on measuring Smoking, Nicotine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • George Washington University School of Public Health
  • Penn State College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reduced Nicotine Content Cigarettes

Same Nicotine Content Cigarettes

Arm Description

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.

The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)

Outcomes

Primary Outcome Measures

Number of Participants Who Dropped Out of Study as a Measure of Adherence
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

Predictors of Participant Dropout
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.
Cigarettes Per Day
Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back
Nicotine Exposure
Measured by cotinine (ng/ml) measured in plasma
Smoke Exposure
Measured in carbon monoxide levels by expired CO
Perceived Stress
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.
Cortisol
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.

Full Information

First Posted
August 21, 2013
Last Updated
April 16, 2019
Sponsor
Milton S. Hershey Medical Center
Collaborators
George Washington University, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01928719
Brief Title
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Official Title
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2015 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
George Washington University, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Smoking, Nicotine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Nicotine Content Cigarettes
Arm Type
Experimental
Arm Description
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.
Arm Title
Same Nicotine Content Cigarettes
Arm Type
Placebo Comparator
Arm Description
The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)
Intervention Type
Drug
Intervention Name(s)
Reduced Nicotine Content Cigarettes
Other Intervention Name(s)
Nicotine
Intervention Description
Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
Intervention Type
Drug
Intervention Name(s)
Same Nicotine Content Cigarettes
Other Intervention Name(s)
Nicotine
Intervention Description
about 11.6 mg nicotine per cigarette
Primary Outcome Measure Information:
Title
Number of Participants Who Dropped Out of Study as a Measure of Adherence
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Predictors of Participant Dropout
Description
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.
Time Frame
18 weeks
Title
Cigarettes Per Day
Description
Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back
Time Frame
18 weeks
Title
Nicotine Exposure
Description
Measured by cotinine (ng/ml) measured in plasma
Time Frame
18 weeks
Title
Smoke Exposure
Description
Measured in carbon monoxide levels by expired CO
Time Frame
18 weeks
Title
Perceived Stress
Description
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.
Time Frame
18 weeks
Title
Cortisol
Description
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.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Muscat, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly Horn, PhD
Organizational Affiliation
George Washington University School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
George Washington University School of Public Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28673312
Citation
Krebs NM, Allen SI, Veldheer S, Martinez DJ, Horn K, Livelsberger C, Modesto J, Kuprewicz R, Wilhelm A, Hrabovsky S, Kazi A, Fazzi A, Liao J, Zhu J, Wasserman E, Reilly SM, Reinhart L, Trushin N, Moyer RE, Bascom R, Foulds J, Richie JP Jr, Muscat JE. Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Trials. 2017 Jul 3;18(1):300. doi: 10.1186/s13063-017-2038-9. Erratum In: Trials. 2017 Dec 15;18(1):598.
Results Reference
derived

Learn more about this trial

Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

We'll reach out to this number within 24 hrs