Evaluation of Very Low Nicotine Content Cigarettes in Ado... | NCT02587312

Studies
Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

NCT02587312

Sponsor

Brown University

Status

Completed

Last Update Posted

Oct 27, 2022Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Nicotine Dependence

Interventions

Very low nicotine content cigarettes
Standard nicotine content cigarettes

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2016Actual

Primary Completion Date

Aug 28, 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 26, 2015

First Posted Date

Oct 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2022

Last Update Posted Date

Oct 27, 2022Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Nicotine Content Cigarettes	Active Comparator	SPECTRUM cigarette: 0.8 mg nicotine with 10.5 mg tar (standard nicotine and tar yields of commercially available cigarettes; control condition)	Other: Standard nicotine content cigarettes
Very Low Nicotine Content Cigarettes	Experimental	SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar	Other: Very low nicotine content cigarettes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Very low nicotine content cigarettes	Other		Very Low Nicotine Content Cigarettes
Standard nicotine content cigarettes

Measure	Description	Time Frame
Number of cigarettes smoked per day		End of 3-week intervention

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Brown University School of Public Health		Providence	Rhode Island	02912	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided