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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02587312
Other study ID # 1K01CA189300
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2016
Est. completion date August 31, 2019

Study information

Verified date October 2022
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 31, 2019
Est. primary completion date August 28, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 19 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Very low nicotine content cigarettes

Standard nicotine content cigarettes


Locations

Country Name City State
United States Brown University School of Public Health Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of cigarettes smoked per day End of 3-week intervention
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