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Table 1 Timing of study measures

From: Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics

 

Baseline/Start Rx

     

End of treatment

 

Week

 

1

2

3

6

9

12

24

Study measures

        

Sociodemographic characteristics

X

       

Tobacco use behavior, FTNDa

X

  

X

X

X

X

X

Smoking endpointsb

   

X

X

X

X

X

Medication adherence

 

X

X

X

X

X

X

 

Mini-International Neuropsych. Interview

X

  

X

X

X

X

X

Modified scale for suicidal ideation

X

  

X

X

X

X

 

Brief symptom Inventory

X

  

X

X

X

X

X

Medication adverse events

 

X

X

X

X

X

X

 

Alcohol and other drug use

X

  

X

X

X

X

X

Urine toxicology tests

X

  

X

X

 

X

 

Medication adverse events

 

X

X

X

X

X

X

 

Subject reimbursement

        

$ Amountc

$15

$10

$10

$15

$15

$15

$15

$15

  1. aFagerström Test for Nicotine Dependence.
  2. bCarbon monoxide-verified abstinence, number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence score, quit attempts lasting ≥ 24 hours.
  3. cTo ensure pill count completion, TAU subjects will be given partial reimbursement ($5-$10 dollars per visit) for research assessments and $5 for completion of pill counts at each follow-up visit during the intervention period.