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Table 1 Time and events schedule with measures, questionnaires, and procedures for study

From: A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

 

Baseline

Randomization

Treatment Choice

 

Baseline I

Baseline II

Step 1

Step 2

Step 3

Step 4

Step 5

Study Week Number

0

1

2

3

6

9

12

15

18

21

25

33

Study Day

1

8

15

22

43

64

85

106

127

148

176

232

Study Visit Number

1

2

3

4

5

6

7

8

9

10

11

12

Measures/Questionnaires

            

Tobacco and marijuana use and daily cigarette loga

 

X

X

X

X

X

X

X

X

X

X

X

Concomitant medicationsa

 

X

X

X

X

X

X

X

X

X

X

X

Adverse eventsa [39]

 

X

X

X

X

X

X

X

X

X

X

X

Demographics

X

           

Tobacco use history, cigarette detailsa

X

X

          

NIDA drug use (past 3 mo) [40]

X

     

X

  

X

  

Environmental smoke questionnaire [41]

 

X

 

X

X

X

X

X

X

X

X

X

Perceived Health Risk

 

X

 

X

  

X

  

X

  

Cigarette Liking Scale [42]

X

X

X

X

X

X

X

X

X

X

  

Nicotine dependence (HONC, FTND, PSU) [43–45]

X

X

X

X

X

X

X

X

X

X

X

X

Minnesota Nicotine Withdrawal Scale [25]

X

X

X

X

X

X

X

X

X

X

X

X

Smoking urges [46, 47]

X

X

 

X

X

X

X

X

X

X

X

X

Audit-C [48, 49]

 

X

 

X

 

X

 

X

 

X

  

Anxiety symptoms questionnaire (ASQ) [50, 51]

X

     

X

  

X

X

X

CES-D[52]

X

     

X

  

X

X

X

Kessler K6 scale [53, 54]

X

X

 

X

X

X

X

X

X

X

X

X

OASIS (anxiety) [24]

X

X

 

X

X

X

X

X

X

X

X

X

QIDS (depression) [23]

X

X

 

X

X

X

X

X

X

X

X

X

Perceived Stress Scale [55]

X

X

 

X

X

X

X

X

X

X

X

X

Clinical COPD questionnaire [56]

 

X

 

X

X

X

X

X

X

X

X

X

Menthol [57]

 

X

X

X

X

X

X

X

X

X

X

 

Pittsburgh Sleep Symptom and Dreams Questionnaires [58, 59]

X

        

X

  

INTERHEART and WI-PREPARE [60, 61]

X

        

X

  

Smoking cessation (if chosen by participant) [29]

         

X

X

X

NRT disbursement (if chosen by participant)

         

X

X

 

Biomeasures/Proceduresb

            

Weight [62]

X

X

X

X

X

X

X

X

X

X

X

X

Height [62]

X

           

Waist hip ratio [62]

X

        

X

  

Exhaled CO [63]

X

X

X

X

X

X

X

X

X

X

X

X

Blood pressure/pulse [39, 64]

X

X

X

X

X

X

X

X

X

X

X

X

Pulmonary function (spirometry) [65]

X

X

  

X

  

X

X

X

X

X

Urine collection

 

X

 

X

X

X

X

X

X

X

X

 

Pregnancy test

X

  

X

 

X

 

X

 

X

X

X

Blood collection for biomarker analysis

 

X

 

X

X

X

X

X

X

X

X

 

Payment

$40

$80

$40

$80

$80

$80

$80

$80

$80

$80

$80

$40+ compliance

  1. NIDA National Institute on Drug Abuse, HONC Hooked on Nicotine Checklist, FTND Fagerstrom Test for Nicotine Dependence, PSU Pennsylvania State University, ASQ Anxiety Screening Questionnaire, CES-D Center for Epidemiologic Studies Depression Scale, OASIS Overall Anxiety Severity and Impairment Scale, QIDS Quick Inventory of Depressive Symptomatology, COPD chronic obstructive pulmonary disease, WI-PREPARE Wisconsin Predicting Patient’s Relapse, NRT nicotine replacement therapy
  2. aTo be completed by the researcher. All others will be completed by the participant
  3. bAll biomeasures/procedures to be completed by researcher. Some biomarkers will be analyzed in selected subgroups of collected samples
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BMC Public Health

ISSN: 1471-2458

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