Addiction and Behavior Related to Menthol Cigarette Substitutes

NCT04844762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-09

Study results available
· View outcomes & findings →

Summary

The goal of the proposed study is to examine the abuse liability and substitutability of plausible menthol cigarette alternatives currently on the market, including menthol filtered little cigars (mFLC), menthol roll-your-own (mRYO) pipe tobacco and cigarette tubes, and non-menthol cigarettes (nmC). In addition, the study will elucidate real-time mechanisms including product characteristics and perceived effects associated with greater substitution.

Conditions

  • Smoking (Tobacco) Addiction

Interventions

BEHAVIORAL

Menthol cigarettes substitutes

In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.

BEHAVIORAL

Usual brand menthol cigarettes and substitutes

In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week.

BEHAVIORAL

Menthol cigarettes substitutes and menthol cigarettes

In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task.

Sponsors & Collaborators

  • University of Vermont

    collaborator OTHER
  • Brown University

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Theodore Wagener, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2021-08-09
Completion
2021-08-09

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844762 on ClinicalTrials.gov