Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Tobacco Dependence Clinical Trial

Official title:

Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928719
• Other study ID #: 43804UG-P1
• Secondary ID: P50DA036107-01
• Status: Completed
• Phase: N/A
• Start date: September 9, 2015
• Est. completion date: February 23, 2018

Study information

• Verified date: April 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 23, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Reduced Nicotine Content Cigarettes
Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
• Same Nicotine Content Cigarettes
about 11.6 mg nicotine per cigarette

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	George Washington University School of Public Health	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	George Washington University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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