Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

NCT03311646 | Completed Results

• 2 other identifiers: 950R03DA045197
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• Breath Sample (Expired Carbon Monoxide)

  Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.

  8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5

• Average Cigarettes Smoked Per Day

  Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.

  Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition.

Secondary Outcomes (2)

• Minnesota Nicotine Withdrawal Scale

  Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition.

• Questionnaire of Smoking Urges

  Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.

Study Arms (1)

Nicotine Content Manipulation

EXPERIMENTAL

All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition.

Other: Normal nicotine content cigarettes (NNC, Baseline); Other: Very low nicotine content (VLNC)

Interventions

Normal nicotine content cigarettes (NNC, Baseline) OTHER

Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel.

Nicotine Content Manipulation

Very low nicotine content (VLNC) OTHER

Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel.

Nicotine Content Manipulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female participants who are least 18 years old and smoke daily
• willing to stay in a hotel for two four-night stays during the prearranged dates

You may not qualify if:

• unwilling to use research cigarettes as part of the trial
• pregnant, trying to become pregnant, or breastfeeding
• additional smoking and health criteria determined at screening

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Smith TT, Koopmeiners JS, White CM, Denlinger-Apte RL, Pacek LR, De Jesus VR, Wang L, Watson C, Blount BC, Hatsukami DK, Benowitz NL, Donny EC, Carpenter MJ. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2020 Apr;29(4):880-886. doi: 10.1158/1055-9965.EPI-19-0963. Epub 2020 Feb 26.

  PMID: 32102910 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Tracy Smith
• Organization: Medical University of South Carolina

smithtra@musc.edu

843-792-5164

Study Officials

• Tracy Smith, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants experienced an NNC phase (baseline) and a VLNC phase.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 17, 2017
• Study Start: April 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: December 1, 2018
• Last Updated: January 28, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

US (1)