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Table 1 Schedule of enrolment, intervention and assessments based on SPIRIT 2013 guidelines [27]

From: Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence

Week

−2

−1

1

2

3

4

5

6

7

8

12

Informed Consent

          

Eligibility

          

Demographic data

          

Height

          

Medical & Psychiatric History

          

Self-reported drug use

          

Concomitant medications

          

Intervention

           

Treatment as usual (counselling) offered weekly

           

Dose of Lisdexamfetamine (mg)-dispensed daily

 

100

150

200

250

250

200

150

100

End

FU

Baseline Measures

           

MOCA, AUDIT, WTAR, Wender Utah Scale

 

         

Primary Outcomes

           

 Brief Psychiatric Scale: psychosis & hostility items

 

 Vital Signsa (Blood pressure, pulse, temperature)

t

t

t

t

 Insomnia Severity Index

 

 

 

 

 

 Patient Health Questionnaire 15

 

   

   

 Patient Health Questionnaire 9

 

 

 

 

 

 Generalized Anxiety Disorder 7

 

 

 

 

 

 Weight (in kilograms)

   

   

 Adverse Events Log

 

 Electrocardiogram

  

 

     

 TSQM-side-effects item

  

 Proportion completing dose escalation phase

     

     

Secondary Outcomes

           

 Substance Use TLFB-MA (Days Used)

 Urine Drug Screen (positive MA)

d

 Substance Use TLFB-MA (Days Used)

 

 Urine Drug Screenc

d

 TSQM-effectiveness item

 

 Visual Analogue Scale for MA craving

 

t

t

t

t

t

 Amphetamine Withdrawal Questionnaire

 

t

t

t

t

t

 Severity of Dependence Scale

 

       

 Adapted Opiate Treatment Index (HIV & crime scales)

 

   

    

 TSQM-convenience & global satisfaction items

 

 Proportion discontinuing once enrolled

  

 

 Price would Pay

 

b

b

b

b

b

     

 Similarity to MA Visual Analogue Scale

 

b

b

b

b

b

     

 Drug Effects Questionnaire 5

 

b

b

b

b

b

     

 Acute Subjective Response to Substances

 

b

b

b

b

b

     

 Trail-making Test

 

t

t

t

t

t

    

 Rey Auditory Verbal Learning Task

 

t

t

t

t

t

    

 Digit-span sequencing

 

t

t

t

t

t

    

 Flankers Test with no-go

 

 

 

    

 Digit Symbol Substitution

 

 

 

    

 Rapid Information Processing

 

 

 

    

  1. Abbreviations: ttimed trough/peak measurements prior to study drug administration/4 h post, TSQM Treatment Satisfaction Questionnaire for Medications, MOCA Montreal Cognitive Assessment, AUDIT Alcohol Use Disorder Identification Test, WTAR Wechsler Test of Adult Reading, MA methamphetamine, TLFB Time-Line Follow Back questionnaire
  2. avital signs measured daily
  3. bMeasurement taken 4 h post study drug administration
  4. cUrine drug screen for benzodiazepines, cannabis, cocaine, methadone, morphine/heroin and oxycodone
  5. dTwo urines positive for methamphetamine required for eligibility