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Trial registered on ANZCTR


Registration number
ACTRN12623000438651
Ethics application status
Approved
Date submitted
7/04/2023
Date registered
1/05/2023
Date last updated
14/05/2024
Date data sharing statement initially provided
1/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Tu Whakaruruhau: The New Zealand Methamphetamine Treatment Evaluation Study
Scientific title
The evaluation of treatment outcomes for methamphetamine dependence in Aotearoa New Zealand
Secondary ID [1] 309407 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Dependence 329642 0
Methamphetamine dependence 329643 0
Condition category
Condition code
Mental Health 326564 326564 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be adults who meet DSM-5 criteria for stimulant use disorder. One group (the exposure group - in-treatment-group (ITG)) will be engaged in treatment at the time of the baseline interview (Residential rehabilitation, or outpatient counselling, or detoxification) and the comparator group will not be engaged in treatment (NITG) at the baseline interview. All participants will complete a battery of questionnaires taking approximately one to one and a half hours at each assessment and will be followed up over two years (baseline, 3-, 12-, and 24 -month interviews). The questionnaires will cover substance use, co-morbid psychiatric diagnosis, general heath and wellness, criminal involvement, Blood borne virus risk behaviours, health service utilisation, treatment characteristics and treatment exposure.
Intervention code [1] 325842 0
Diagnosis / Prognosis
Comparator / control treatment
People who meet criteria for stimulant use disorder (Methamphetamine) who are not in treatment at the time of entry into the study (i.e.., baseline assessment).
Control group
Active

Outcomes
Primary outcome [1] 334409 0
Self-reported methamphetamine use at 12 months (abstinent over last month)
Timepoint [1] 334409 0
12 months post baseline interview
Secondary outcome [1] 420547 0
Abstinence from methamphetamine use at 3, 24 months following baseline - assessed by Q score derived from opiate treatment index
Timepoint [1] 420547 0
3 months and 24 months post baseline interview
Secondary outcome [2] 420548 0
Days of methamphetamine use in last 28 days measured using timeline follow back
Timepoint [2] 420548 0
Baseline, 3-, 12-, 24- months
Secondary outcome [3] 420549 0
Other substance use - self report
Timepoint [3] 420549 0
Baseline and at 3-, 12-, 24-month after baseline interview
Secondary outcome [4] 420550 0
Diagnosis of stimulant use disorder - MINI - International Neuropsychiatric Interview
Timepoint [4] 420550 0
Baseline, 3-, 12-, 24- month interviews
Secondary outcome [5] 420551 0
Severity of psychological dependence on methamphetamine - severity of dependence scale
Timepoint [5] 420551 0
Baseline, 3-, 12-, 24 - month interviews
Secondary outcome [6] 420552 0
DSM-5 diagnosis of psychiatric co-morbidity - MINI - International Neuropsychiatric Interview
Timepoint [6] 420552 0
Baseline interview
Secondary outcome [7] 420553 0
Pre-treatment motivation using the Treatment Entry Questionnaire (TEQ-9) devised by Urbanoski and Wild (2012 : J. Subst. Abuse Treat , 43 (2012) , pp.70-79) and recently validated by Walji et al (Drug and Alcohol Dependence Reports 2 (2022) 100014)..
Timepoint [7] 420553 0
Baseline interview
Secondary outcome [8] 420554 0
Severity of psychiatric symptoms - Scores on the hostility, suspiciousness, unusual thought content and hallucinations subscales of the Brief Psychiatric Rating Scale
Timepoint [8] 420554 0
Baseline, 3-, 12-, 24-months
Secondary outcome [9] 420555 0
Psychological distress - Kessler Psychological Distress Scale
Timepoint [9] 420555 0
Baseline, 3-, 12-, 24- months
Secondary outcome [10] 420556 0
HIV risk behaviour - HIV risk taking behaviour scale of the Opiate treatment Index (OTI) [Darke, S., et al., British Journal of Addiction, 1992. 87(5): p. 733-742.]
Timepoint [10] 420556 0
Baseline, 3-, 12-, 24 - month interviews
Secondary outcome [11] 420557 0
Criminal involvement - CRIME subscale of the Opiate Treatment Index [OTI}
Timepoint [11] 420557 0
Baseline, 3-, 12-, 24- month interviews
Secondary outcome [12] 420558 0
General Wellbeing - Hua Oranga – Tangata Whaiora (patient) questionnaire
Timepoint [12] 420558 0
Baseline, 3-, 12-, 24 - month interviews
Secondary outcome [13] 420559 0
Treatment exposure assessed using a study specific questionnaire utilising self report.
Timepoint [13] 420559 0
3-, 12-, 24 month interviews
Secondary outcome [14] 420560 0
Quality of life - EQ-5D-5L
Timepoint [14] 420560 0
Baseline, 3-, 12-, 24 - month interviews
Secondary outcome [15] 420561 0
Health Service use - self report and data linkage
Timepoint [15] 420561 0
Baseline, 3-, 12-, 24 - month interviews

Eligibility
Key inclusion criteria
Methamphetamine is the main drug of concern
Participants are aged 18 years of age or over
Participants have no severe cognitive disability that may affect their capacity to take part
Participants live in the Northland, Auckland, or Waikato regions of New Zealand.
Participants in the in-treatment-group will include those who have been admitted to treatment within the last two weeks of been screened for the study.
Participants in the Not-In-Treatment-Group [NITG] will include those who at the time of screening where not involved in formal treatment. NITG participants at screening will need to score 4 or more on the Severity of Substance Dependence Scale (SDS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who, in the last 30 days, have received any treatment for methamphetamine /amphetamine use, any in-patient drug treatment or imprisonment. NB: Participants in treatment will not be eligible to participate in this study if they received any treatment for methamphetamine /amphetamine use (any in-patient drug treatment or imprisonment, in the 30 days prior to starting the current treatment episode).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size was determined by an a priori power analysis. Two sample sizes based on two rates of attrition: ie., 20% and 30%, were determined to inform our recruitment processes. The first sample size is adjusted for 20% attrition and requires 320 participants (3:1 ratio: 240 in the ITG, 80 in the NITG), the second requires 367 participants (3:1 ratio: 275 in the ITG, 92 in the NITG) to provide 90% power at p=0.05 (2-sided alpha) to detect an absolute difference between the two groups of 20% in the proportion of participants at 12-months that have not used MA in the past month (assuming 40% in ITG and 20% in NITG) based on findings from the MATES study. Fifty per cent of participants will self-identify as Maori.

All statistical analyses will be performed using SAS version 9.4 (SAS Institute Inc. Cary NC) . No interim analyses are planned.

All baseline data will be summarized by group. Treatment evaluations for the primary outcome will be carried out an intention-to-treat basis, with multiple imputation analysis used to account for missing data. Sensitivity analyses will be undertaken to determine the impact of missing data. Binary outcomes will be analysed using chi-squared tests and logistic regression analysis where appropriate. The main analyses for the primary outcome will be adjusted for demographics (gender, ethnicity, age) psychiatric co-morbidity, polydrug use, baseline MA dependence, treatment history and treatment re-entry during follow-up and any important imbalances in baseline covariates. To assess the robustness of the main results sensitivity analyses will also be conducted for the primary outcome containing the actual treatment the participant received during the follow-up rather than the index treatment group. For continuous outcomes simple means/SDs, and adjusted mean differences will be calculated with 95% CI. The distribution of all continuous outcomes will be assessed for normality and appropriately transformed before analysis if it is deemed necessary. Repeated measures analysis will be used to assess change over time.

To determine predictors of the outcomes (such as demographics, treatment exposure, and psychiatric diagnosis) multiple linear or logistic regression will be used as appropriate. The consistency of effects for prescribed subgroups (Maori status, age and sex) will be assessed using tests for heterogeneity. In order to eliminate any association between the treatment grouping and factors that predict treatment grouping the Inverse Probability of Treatment Weighted estimates of treatment outcomes derived by weighting the samples with the inverse of the ‘propensity to treat’ score will be used.

The impact of differential sample attrition (i.e. there may be differences in those not successfully followed up to those located and interviewed) will be corrected using the methods of Berk (1983). The main predictor variable will be treatment exposure (indicated by retention in treatment, treatment completion, and dose (days) of treatment received). Covariates will include demographics (age, gender, employment status), psychiatric comorbidity, polydrug use, and dependence on methamphetamine at baseline.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
26/10/2023
Date of last participant enrolment
Anticipated
25/10/2024
Actual
Date of last data collection
Anticipated
25/10/2027
Actual
Sample size
Target
320
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 25382 0
New Zealand
State/province [1] 25382 0
Auckland
Country [2] 25383 0
New Zealand
State/province [2] 25383 0
Northland
Country [3] 25384 0
New Zealand
State/province [3] 25384 0
Waikato

Funding & Sponsors
Funding source category [1] 313602 0
Government body
Name [1] 313602 0
Health Research Council of New Zealand
Country [1] 313602 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315392 0
None
Name [1] 315392 0
Address [1] 315392 0
Country [1] 315392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312778 0
Health and Disability Ethics Committees
Ethics committee address [1] 312778 0
Health and Disability Ethics Committees
Ministry of Health Ethics
133 Molesworth Street
PO Box 5013
Wellington
NZ 6011
Ethics committee country [1] 312778 0
New Zealand
Date submitted for ethics approval [1] 312778 0
05/04/2023
Approval date [1] 312778 0
28/07/2023
Ethics approval number [1] 312778 0

Summary
Brief summary
Methamphetamine (MA) is the second most commonly used illicit drug in Aotearoa New Zealand (NZ). Regular/heavy users are likely to develop a dependence syndrome and experience a range of physical and psychological adverse effects; many will return to using following attempts at abstinence. Given these adverse effects, some people who use MA are likely to want or need to access treatment to help them reduce the harms associated with their use, and to ultimately quit. However, the availability of effective treatment options, and the evidence about what works for problematic MA use, is limited. The aim of this research is to improve our understanding of what treatment approaches reduce MA use and related physical and psychosocial harms, and to identify the predictors of positive treatment outcomes in NZ.
Trial website
https://twstudy.auckland.ac.nz/about-us
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125882 0
A/Prof David Newcombe
Address 125882 0
Medical and Health Sciences Building 507
22-30 Park Avenue
Grafton,
Auckland 1023
Country 125882 0
New Zealand
Phone 125882 0
+64 9 923 6557
Fax 125882 0
Email 125882 0
[email protected]
Contact person for public queries
Name 125883 0
David Newcombe
Address 125883 0
Medical and Health Sciences Building 507
22-30 Park Avenue
Grafton,
Auckland 1023
Country 125883 0
New Zealand
Phone 125883 0
+64 9 923 6557
Fax 125883 0
Email 125883 0
[email protected]
Contact person for scientific queries
Name 125884 0
David Newcombe
Address 125884 0
Medical and Health Sciences Building 507
22-30 Park Avenue
Grafton,
Auckland 1023
Country 125884 0
New Zealand
Phone 125884 0
+64 9 923 6557
Fax 125884 0
Email 125884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.