Concerned about your own or
someone else’s drug use?

Outcome Assessed

Measures Used

Variations on Analysis

Primary Outcomes

Abstinence

(from AMPH, MA, or Amphetamine-Type Substance [ATS]) (n=51)

Urine Drug Screen (UDS) (n=41)

Variations in cut-off points and measures:
1,000 ng/ml (n=1)
300 ng/ml (n=2)
Confirmed by Mass Spectrometry
78 ng/ml (n=1)
<300 ng/ml (n=1)

Comparing proportion of participants in each group demonstrating abstinence in the final 2 weeks of study – abstinence defined by having all UDS’ test negative and providing at least two UDS per week (n=1)

Comparing proportion of participants in each group demonstrating abstinence in the final 2 weeks of study – abstinence defined by having all UDS’ test negative and providing all UDS in final 2 weeks of study (=3)

Negative UDS during final 2 weeks of treatment and no more than 1 of 3 possible UDS missing per week (n=2)

Weekly proportion of negative UDS (or weekly proportion of positive UDS) (n=5)

Proportion of UDS testing negative during the study (n=5)

Treatment Effectiveness Score (TES):
the sum of the number of negative (AMPH, MA, ATS) UDS during the treatment phase per participant (n=3)
average of the sum of negative UDS submitted per participant in each treatment arm (n=1)

Joint Probability Index: number of negative (AMPH, MA, ATS) UDS submitted by each participant in each treatment group at time point (end-of-treatment or follow-up visit) divided by the number of participants randomised to that treatment group (n=3)

Longest period of uninterrupted abstinence (n=3)

Percentage of participants with at least:
2-weeks abstinence (n=2)
3-weeks abstinence (n=3) 

Drug “free” week: A week in which all non-missing urine samples in the week (3 samples/week) were drug free (AMPH, MA, ATS) (n=1)

Negative “use week” (n=1)

UDS collected 3 times per week: "use week" defined as each 7-day period beginning with first dose of study drug.
A “positive use week" was any week in which ≥1 UDS was MA-positive
A "negative use week" was any week in which all UDS were MA-negative, even if only 1-2 UDS were collected
Data were considered missing if 0 UDS were collected

Self-Report (n=4)

Abstinence for 21 days any time during the study period (n=2)

Days per week (e.g. self-reported non-use days) (n=1)

Frequency of use in prior 2 weeks (AMPH, MA, ATS) (n=1)

Drug Diaries

28-days prospective (n=1)

Time Line Follow Back (TLFB) (n=2)

Opiate Treatment Index (OTI) (n=1)

For self-reported MA use substituted for opiates

Hair analysis (n=1)

Changed use / reduction in use (n=7)

Reduction in UDS positive metabolites (n=3)

Decrease in average weekly log10 median urine MA concentrations over treatment period

Overall change in proportion of positive UDS
(amph, MA, ATS) (n=3)

Over study period (n=2)
Per week (n=1)

New MA use (n=1)

Determined by: MA-positive first sample; following sample with no MA; MA detected in subsequent sample; following sample with MA detected; MA detected in subsequent sample in greater quantities that would be expected on the basis of mean half-life plus 2 Standard Deviations (SD); Participant self-reports new use of MA since prior sample.

UDS (n=3)

Number of non-use weeks (n=1)
Number of negative UDS during treatment (n=1)
Number of abstinence events (n=1)

Amphetamine Withdrawal Questionnaire (AWQ) (n=1)

Craving (n=10)

Visual Analogue Scales (VAS) (n=5)

10 mm (point) VAS (n=1)
100 mm (point) VAS (n=1)

Brief Substance Craving Scale (BSCS) (n=1)

Questionnaire for Evaluating Cocaine Craving and Related Responses (QECCRR) (n=1)

Cocaine Craving Questionnaire – Brief (CCQ-B) (n=2)

Penn Craving Scale (n=1)

Withdrawal (n=3)

AWQ (n=1)

Amphetamine Cessation Symptoms Assessment (ACSA) (n=1)

Amphetamine Selective Severity Assessment (ASSA) (n=1)

Dependence (n=3)

Leeds Dependence Questionnaire (LDQ) (n=1)

Addiction Severity Index (ASI) / ASI-Lite (n=1)

Severity of Dependence Scale (SDS) (n=1)

Depression (n=1)

Beck Depression Inventory (BDI) (n=1)

Psychopathology (n=1)

Brief Symptom Inventory (BSI) (n=1)

Clinical Impression(n=1)

Clinical Global Impression Scale (CGI) (n=1)

Retention in Treatment / Study (n=5)

Average duration of time in care (n=3)
Number of participants who complete treatment (n=2)

Type and number of adverse events (AE’s) (n=3)

Feasibility to recruit (n=1)
Tolerability of study drug (n=1)

Adherence (n=3)

Pharmacy records (n=1)

Medication Event Monitoring System (MEMS) caps (n=1)

Study drug metabolites in urine (n=1)

Outcome Assessed

Measures Used

Variations on Analysis

Secondary Outcomes

Abstinence

(from AMPH, MA, or Amphetamine-Type Substance [ATS]) (n=51)

Urine Drug Screen (UDS) (n=10)

Comparing proportion of participants in each group demonstrating abstinence in the final 2 weeks of study – abstinence defined by having all UDS test negative and providing at least two UDS per week (n=2)

Weekly proportion of negative UDS (or weekly proportion of positive UDS) (n=2)

Proportion of UDS testing negative during the study (n=2)

Treatment Effectiveness Score (TES):
average of the sum of negative UDS submitted per participant in each treatment arm (n=1)

Self-Report 

Days since last use (n=1)

Abstinence for 21 days any time during the study period (n=1)

Days per week (e.g. self-reported non-use days) (n=4)

Frequency of use in prior 2 weeks (AMPH, MA, ATS) (n=1)

Drug Free Days (n=1)

Time Line Follow Back (TLFB) (n=3)

Opiate Treatment Index (OTI) (n=1)

Drug use subscale

Changed use / reduction in use (n=4)

Reduction in UDS positive metabolites (n=2)

Decrease in average weekly log10 median urine MA concentrations over treatment period

Time to relapse (n=2)

Amongst those who previously achieved abstinence (n=1)
Relapse for participants with negative MA UDS at baseline (n=1)

Craving (n=25)

Visual Analogue Scales (VAS) (n=16)

7 mm (point) VAS (n=1)
100 mm (point) VAS (n=5)

Brief Substance Craving Scale (BSCS) (n=6)

Stimulant Craving Questionnaire (STCQ) (n=1)

“Desires for Speed” modification of “Desires for Alcohol” Questionnaire (n=1)

Craving-Questionnaire-Now version (CQ-Now) (n=1)

Withdrawal (n=5)

AWQ (n=3)

Amphetamine Cessation Symptoms Assessment (ACSA) (n=1)

Methamphetamine Withdrawal Questionnaire (MAWQ) (n=1)

Dependence (n=14)

Addiction Severity Index (ASI) / ASI-Lite (n=10)

Severity of Dependence Scale (SDS) (n=3)

Amphetamine Selective Severity Assessment (ASSA) (n=1)

Beck Depression Inventory (BDI) (n=1)

Montgomery-Åsberg Depression Rating Scale (n=2)

Centre for Epidemiologic Studies Depression Scale (CES-D) (n=4)

Hamilton Depression Rating Scale (HAM-D) (n=4)

Beck Depression Inventory II (BDI-II) (n=1)

Depression Anxiety Stress Scale (DASS) (n=1)

Full scale and sub-scores

Anxiety (n=3)

Hamilton Rating Scale for Anxiety (HAM-A) (n=1)

Beck Anxiety Inventory (n=1)

Anxiety State Index (n=1)

Psychological Distress (n=1)

PHQ-2 (n=1)

Psychopathology (n=2)

Brief Symptom Inventory (BSI) (n=1)

Positive and Negative Symptoms Scale (PANSS) (n=1)

Clinical Impression (n=9)

Clinical Global Impression Scales: Observer (CGI-O) (n=3)

Clinical Global Impression Scales: Self (CGI-S) (n=4)

Days admitted as inpatient (n=3)
Number of days received study drugs following first dose (n=1)
Number of days attended from randomisation to the final study visit (n=1)
Provision of at least one UDS during Week 8 of study (n=1)
Days between first study drug infusion and last clinic visit (n=1)
Study drug doses collected (n=1)
Number of treatment days during outpatient treatment until the last clinical contact (n=3)

Participant Satisfaction (n=1)

Percentage of participants completing active medication, mean number weeks in treatment (n=1)

Adherence (n=13)

Self-report using AIDS Clinical Trials Group Questionnaire (ACTG) (n=1)

Pill count (n=7)

Medication Event Monitoring System (MEMS) caps (n=2)

Study drug metabolites in urine (n=2)

Dose logs (n=1)

HIV Risk-Taking Behaviour Scale (HRBS) (n=1)

HIV Risk Assessment Battery (n=1)

Audio Computer Assisted Interview (ACASI) for self-report (n=2)

Number male partners
Number male partners with whom MA used
Episodes anal sex (insertive / receptive) with HIV serodiscordant partners
Drug use
Substance use treatment
Sexual risk behaviour

Adult ADHD Clinical Diagnostic Scale (ACDS) (n=1)

Adult ADHD Investigator Symptom Rating Scale (AISRS) (n=1)

Barratt Impulsiveness Scale (n=1)

Neuro-cognition (n=1)

Cambridge Neuropsychological Test Automated Battery (CANTAB) (n=1)

Safety (n=7)

Serious Adverse Events (SAE’s) / Adverse Events (AE’s) (n=3)

Physiological Indicators (n=4)

Vital statistics (n=3)
Electrocardiogram (ECG) results (n=1)

Quality of Life (n=3)

The Quality of Life Inventory (QoLI) (n=1)

Euro-QoL (n=1)

Global Assessment of Functioning (GAF) score (n=1)

Sheehan Disability Scale (n=1)

Athens Insomnia Scale (AIS-5) (n=1)

St Mary’s Hospital Sleep Questionnaire (n=1)

Cigarettes (n=3)

Weekly number cigarettes in smoker subgroup (n=2)
Carbon Monoxide tests (n=1)

Other adverse effects (n=4)

Liver Function Tests (LFTs) (n=1)

Abnormal Involuntary Movement Scale (AIMS) (n=1)

Barnes Akathisia Scale (BAS) (n=1)

Simpson Angus Scale (SAS) (n=1)