CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 305 enrolled
Drug / intervention
SPECTRUM cigarettes +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02951143
NCT02951143N/ACompleted

Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace

Virginia Polytechnic Institute and State University·interventional·Posted Nov 1, 2016·Updated Sep 22, 2021

In Brief

A clinical study evaluating SPECTRUM cigarettes and SPECTRUM cigarettes between for Substance-Related Disorders. Completed, enrolled 305 participants across 1 site.

Detailed Summary

Tobacco regulatory policies can have unanticipated consequences; therefore, methods that would permit prospective estimates of the effects of potential tobacco regulations are necessary for the development of tobacco regulatory science. The goal of this project is to experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is related to nicotine content and absorption. In experiment 2, we will investigate how purchasing/consuming changes when other nicotine products are available in an experimental marketplace setting. The proposed projects can directly inform tobacco regulation by providing estimates of the real-world effects of novel policies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 1, 2016
Enrollment StartJan 1, 2017
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.7 years ago

Interventions

SPECTRUM cigarettesdrug

Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.

SPECTRUM cigarettes betweendrug

Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.