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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           
Demographic data           
Medical & Psychiatric History           
Self-reported drug use           
Concomitant medications           
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  
 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