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Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Primary Purpose

Nicotine Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Very low nicotine content cigarettes

Standard nicotine content cigarettes

About this trial

This is an interventional basic science trial for Nicotine Dependence

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher).
Participants must speak and comprehend English well enough to complete study procedures.

Exclusion Criteria:

Current pregnancy
Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana).
Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year
Participants who report current suicidal ideation on the MINI suicide subscale questions 4 & 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime
Participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days

Sites / Locations

Brown University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Nicotine Content Cigarettes

Very Low Nicotine Content Cigarettes

Arm Description

SPECTRUM cigarette: 0.8 mg nicotine with 10.5 mg tar (standard nicotine and tar yields of commercially available cigarettes; control condition)

SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar

Outcomes

Primary Outcome Measures

Number of cigarettes smoked per day

Secondary Outcome Measures

Full Information

NCT ID

NCT02587312

First Posted

October 23, 2015

Last Updated

October 26, 2022

Sponsor

Brown University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02587312

Brief Title

Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Official Title

Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

October 13, 2016 (Actual)

Primary Completion Date

August 28, 2019 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brown University

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. In this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline period. Participants will be instructed to smoke only those cigarettes. The researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. Such knowledge will contribute to the science base that may inform future policy decisions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Nicotine Content Cigarettes

Arm Type

Active Comparator

Arm Description

SPECTRUM cigarette: 0.8 mg nicotine with 10.5 mg tar (standard nicotine and tar yields of commercially available cigarettes; control condition)

Arm Title

Very Low Nicotine Content Cigarettes

Arm Type

Experimental

Arm Description

SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar

Intervention Type

Other

Intervention Name(s)

Very low nicotine content cigarettes

Intervention Type

Other

Intervention Name(s)

Standard nicotine content cigarettes

Primary Outcome Measure Information:

Title

Number of cigarettes smoked per day

Time Frame

End of 3-week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher). Participants must speak and comprehend English well enough to complete study procedures. Exclusion Criteria: Current pregnancy Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana). Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year Participants who report current suicidal ideation on the MINI suicide subscale questions 4 & 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime Participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days

Facility Information:

Facility Name

Brown University School of Public Health

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02912

Country

United States

12. IPD Sharing Statement

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Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

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