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 | ● | ● | ● | ● |