Clinical trial NCT01928719: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking
Nicotine
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: George Washington University
name: National Institute on Drug Abuse (NIDA)
First posted: 2013-08-27
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Who Dropped Out of Study as a Measure of Adherence
timeFrame: 18 weeks
Secondary outcomes:
measure: Predictors of Participant Dropout
timeFrame: 18 weeks
measure: Cigarettes Per Day
timeFrame: 18 weeks
measure: Nicotine Exposure
timeFrame: 18 weeks
measure: Smoke Exposure
timeFrame: 18 weeks
measure: Perceived Stress
timeFrame: 18 weeks
measure: Cortisol
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University School of Public Health
state: District of Columbia
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Joshua Muscat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University School of Public Health
name: Kimberly Horn, PhD
role: STUDY_DIRECTOR
References:
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.