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Table 1 Study assessments

From: A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol

TIMEPOINT

Intake

Week − 1

Week 0

Week 2

Week 4

Week 6

Week 8

Week 12

Enrollment

        

Eligibility screening

x

       

Informed Consent

x

       

Randomization

  

x

     

Interventions

        

Usual brand menthol cigarettes available

 

x

      

Cigarettes and e-cigarettes available by regulatory scenario: (A) no menthol ban, (B) menthol ban in cigarettes only, or (C) menthol ban in both cigarettes and e-cigarettes

  

x

x

x

x

x

 

Assessments

        

Demographics

x

       

Tobacco use history

x

       

Medical history interview

x

       

Mood (anxiety GAD-7a, depression PHQ-8b)

 

x

      

Quality of lifec

 

x

    

x

 

Racial trauma and discrimination (TSDSd) and ethnic identity (MEIMe)

 

x

      

Timeline follow-back interviewf (cigarettes, e-cigarettes, cannabis and other tobacco products)

x

x

x

x

x

x

x

x

Nicotine dependence (cigarette and e-cigarette PROMIS measures)g,h

  

x

 

x

 

x

x

Wisconsin Inventory of Smoking Dependence Motives (WISDM-37)i

 

x

    

x

 

Time to first cigarette (FTND)j

 

x

x

 

x

 

x

x

Cigarette quitting motivation and confidencek

  

x

   

x

x

Product satisfaction (Modified cigarette evaluation scale, modified e-cigarette evaluation scale)l,m

  

x

x

x

x

x

 

Product cravingn (cigarette, e-cigarette)

  

x

x

x

x

x

x

Nicotine withdrawal (Minnesota Nicotine Withdrawal Scaleo)

  

x

x

x

x

x

x

Health and safety assessment

 

x

x

x

x

x

x

x

Protocol adherence measures (spent cigarette filters, e-cigarette pods, use of other mentholated products)

 

x

x

x

x

x

x

x

Biochemical measures

        

Urine pregnancy test

x

x

x

x

x

x

x

 

Urine biomarkers (cotinine, total nicotine equivalents, menthol glucuronide)

x

 

x

 

x

 

x

 

Expired breath carbon monoxide (CO)

x

x

x

x

x

x

x

x

Spirometer lung function test

x

x

x

x

x

x

x

 
  1. Footnotes:
  2. aGeneralized Anxiety Disorder-7 (GAD-7) [47]; bPatient Health Questionnaire-8 (PHQ-8): 8-item version adapted from the PHQ-9 [48]; cQuality of Life [49]; dTrauma Symptoms of Discrimination Scale (TSDS) [50]; eMultigroup Ethnic Identity Measure (MEIM) [51, 52]; fTimeline Follow Back Interview (TLFB) [42]; gPROMIS measure of nicotine dependence [53]; hPROMIS measure of e-cigarette dependence [45]; iWisconsin Inventory of Smoking Dependence Motives (WISDM-37) [54, 55]; jFagerstrom Test for Nicotine Dependence (FTND) [56]; kQuitting motivation and confidence: Rated from 1 (not at all) to 10 (extremely) from the PhenX toolkit; lModified Cigarette Evaluation Questionnaire (MCEQ) [57]; mModified E-Cigarette Evaluation Questionnaire (MECEQ) [58]; nCraving measured with 2-items from the Mood and Physical Symptoms Scale (MPSS) [59]; oMinnesota Nicotine Withdrawal Scale (MNWS) [60]