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

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Reduced Nicotine Content Cigarettes; Drug: Same Nicotine Content Cigarettes

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University School of Public Health
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 weeks
Cigarettes Per Day	Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back	18 weeks
Nicotine Exposure	Measured by cotinine (ng/ml) measured in plasma	18 weeks
Smoke Exposure	Measured in carbon monoxide levels by expired CO	18 weeks
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.	18 weeks
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.	15 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); George Washington University
• Investigators: Principal Investigator: Joshua Muscat, PhD, Penn State College of Medicine; Study Director: Kimberly Horn, PhD, George Washington University School of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2015
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Smoking; Nicotine
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 43804UG-P1; P50DA036107-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO