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Trial registered on ANZCTR


Registration number
ACTRN12619000060145
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
17/01/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
17/01/2019
Date results information initially provided
17/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can novel computerised brain training reduce relapse to methamphetamine use?
Scientific title
An open-label pilot study of the feasibility, acceptability, and effectiveness of approach bias modification (ABM) training for methamphetamine use disorder, as indexed by recruitment rate, ABM training completion rate, participants' ratings of ABM tasks, and abstinence from methamphetamine at 2-week and 3-month follow-ups.
Secondary ID [1] 297003 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use disorder 310973 0
Condition category
Condition code
Mental Health 309636 309636 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are testing an "approach bias modification" (ABM) training task. In this task, participants are exposed to 240 computerised images, including 40 images of methamphetamine and paraphernalia associated with its use and 40 different images of fruits and vegetables (each image repeated 3 times during the training) and instructed to respond with an approach or avoidance movement according to their orientation (landscape or portrait). While instructions are based on picture orientation, one orientation, which requires an avoidance movement (pushing of a joystick, which decreases image size), exclusively contains methamphetamine-related images. The other orientation, which require an approach movement (pulling the joystick, which increases image size), exclusively contains images of fruits and vegetables. The requirement to push away all of the methamphetamine-related images is intended to train participants to over-ride their pre-existing tendency to approach methamphetamine. Four sessions of this training are delivered to each participant, by a research assistant, on 4 consecutive days (i.e. 1 session per day), while participants are inpatients in an alcohol and other drug withdrawal unit (i.e. "detox"). Each session takes approximately 15 minutes. Since the intervention is an automated computer programme, fidelity on the part of the researcher delivering the intervention does not need to be assessed. However, if there are any interruptions that prevent a training session being completed as normal (e.g. a software or hardware malfunction during a session, or the participant feeling unable to complete all trials), the researcher conducting the session reports this to the study manager, and this is recorded along with other information about the participant.
Intervention code [1] 313279 0
Behaviour
Intervention code [2] 313280 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318594 0
Proportion of participants who complete the 4-session ABM protocol (as a proportion of those who commence at least 1 session of training)
Timepoint [1] 318594 0
At the time of discharge from the inpatient withdrawal unit.
Primary outcome [2] 318595 0
Proportion of participants who withdraw from the study prior to completion of the 4-session protocol due to finding the training too distressing. When participants inform a researcher that they wish to withdraw from the study, the researcher reports this, along with the participant's stated reason for withdrawal, to the study coordinator.
Timepoint [2] 318595 0
Time of withdrawal
Primary outcome [3] 318596 0
Participants' ratings of the ABM task, i.e. proportion of participants who endorse each of the 5 possible ratings ('strongly agree', 'agree', 'unsure', 'disagree', or 'strongly disagree') in response to the 3 acceptability items detailed in the protocol.
Timepoint [3] 318596 0
Following completion of ABM training.
Secondary outcome [1] 365478 0
Uptake, as indexed by the proportion of eligible patients who agree to participate upon being approached and then commence training.
Timepoint [1] 365478 0
At the time of (attempted) recruitment and commencement of training.
Secondary outcome [2] 365480 0
Ratings on a single-item visual analogue scale measure of methamphetamine craving (anchored on the left and right ends with the words 'not at all' and 'extreme', respectively, and scored 0-100 depending on where the participant marks the scale).
Timepoint [2] 365480 0
Immediately following each of the 4 sessions.
Secondary outcome [3] 365482 0
Proportion of participants abstinent from methamphetamine for at least the first 14 days after discharge from the inpatient withdrawal unit, as self-reported during the timeline follow-back interview.
Timepoint [3] 365482 0
2-week follow-up.
Secondary outcome [4] 365483 0
Proportion of participants reporting past-month abstinence from methamphetamine at the 3-month follow-up, as self-reported during the timeline follow-back interview.
Timepoint [4] 365483 0
3-month follow-up.
Secondary outcome [5] 365484 0
Proportion of participants reporting continuous abstinence since discharge from the withdrawal unit at the 3-month follow-up, as self-reported in response to a question specifically designed for this study.
Timepoint [5] 365484 0
3-month follow-up.

Eligibility
Key inclusion criteria
1. Aged 18-65
2. Meets criteria for moderate or severe methamphetamine use disorder (i.e. at least 4 DSM-5 symptoms).
3. Report at least weekly use of methamphetamine in the month prior to admission to the withdrawal unit.
4. Able to understand English.
5. Able to provide a phone number for follow-up interviews.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of neurological illness or injury
2. History of traumatic brain injury involving loss of consciousness for longer than 30 minutes.
3. Diagnosis of intellectual disability.
4. Too acutely unwell to provide informed consent and/or safely participate, as judged by clinical staff.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistics will be used to analyse all outcomes except for the single-item craving score. For this craving score, linear mixed modelling will be used to test whether there is an acute change in craving immediately after training sessions (relative to the before-session rating) and whether any such change varies according to session number.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12875 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 12876 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 25315 0
3065 - Fitzroy
Recruitment postcode(s) [2] 25316 0
3128 - Box Hill
Recruitment postcode(s) [3] 25317 0
3183 - St Kilda East

Funding & Sponsors
Funding source category [1] 301574 0
Charities/Societies/Foundations
Name [1] 301574 0
Eastern Health Foundation
Address [1] 301574 0
5 Arnold Street, Box Hill VIC 3128
Country [1] 301574 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold Street, Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 301279 0
None
Name [1] 301279 0
Address [1] 301279 0
Country [1] 301279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302303 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 302303 0
Ethics committee country [1] 302303 0
Australia
Date submitted for ethics approval [1] 302303 0
Approval date [1] 302303 0
08/05/2017
Ethics approval number [1] 302303 0
E03-2017
Ethics committee name [2] 302310 0
Saint Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [2] 302310 0
41 Victoria Parade, Fitzroy, Victoria, 3065
Ethics committee country [2] 302310 0
Australia
Date submitted for ethics approval [2] 302310 0
16/10/2017
Approval date [2] 302310 0
30/11/2017
Ethics approval number [2] 302310 0
207/17

Summary
Brief summary
In recent years, presentations to alcohol and other drug (AOD) treatment services by clients seeking treatment for problems with methamphetamine have increased dramatically in Australia. Withdrawal management (i.e. inpatient “detoxification”) is one of the most common treatments for people with severe methamphetamine use disorder (MUD). However, less than 20% of people who undergo withdrawal management remain abstinent from methamphetamine 3 months later. This highlights the need for brief, adjunctive treatments that can be delivered during inpatient withdrawal to help prevent relapse.

“Approach bias modification” (ABM), a brief computerised cognitive training program designed to reduce impulsive tendencies to approach drug-related stimuli, has been shown to be effective for alcohol use disorders, but has not yet been trialed for methamphetamine. ABM involves repeated trials where patients respond to drug-related and neutral/healthy stimuli (e.g. pictures of alcoholic and non-alcoholic drinks, in the case of alcohol ABM) by “avoiding” drug-related stimuli and “approaching” other stimuli. Before executing costly randomised controlled trials applying ABM for MUD, it is important to establish whether it is acceptable (e.g., whether exposure to images of methamphetamine during ABM is well-tolerated or whether they are excessively triggering/distressing) and whether it is feasible in relevant treatment-settings, including inpatient withdrawal.

The aim of the present study was to examine the feasibility and acceptability of ABM during inpatient withdrawal from methamphetamine. We predicted high rates of uptake and completion of training (demonstrating feasibility); and low rates of withdrawal, minimal triggering of cravings, and high ratings of the tasks’ acceptability from participants (demonstrating acceptability). Although this was a small, uncontrolled, open-label pilot study, we also examined rates of abstinence from methamphetamine at 2-week and 3-month follow-ups, expecting that it would compare favourably with those reported in multi-site treatment outcome studies of MUD patients undergoing inpatient withdrawal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89754 0
A/Prof Victoria Manning
Address 89754 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 89754 0
Australia
Phone 89754 0
+61 3 8413 8724
Fax 89754 0
Email 89754 0
victoria.manning@monash.edu
Contact person for public queries
Name 89755 0
A/Prof Victoria Manning
Address 89755 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 89755 0
Australia
Phone 89755 0
+61 3 8413 8724
Fax 89755 0
Email 89755 0
victoria.manning@monash.edu
Contact person for scientific queries
Name 89756 0
A/Prof Victoria Manning
Address 89756 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 89756 0
Australia
Phone 89756 0
+61 3 8413 8724
Fax 89756 0
Email 89756 0
victoria.manning@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is a condition of the ethical approval that individual participants' data will not be shared outside of the approved team of investigators without further ethical approval.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 982 0
Study protocol
Citation [1] 982 0
Link [1] 982 0
Email [1] 982 0
Other [1] 982 0
Two nearly-identical versions of the protocol were created, because this study was separately approved by 2 different ethics committees.
Type [2] 983 0
Study protocol
Citation [2] 983 0
Link [2] 983 0
Email [2] 983 0
Other [2] 983 0
Two nearly-identical versions of the protocol were created, because this study was separately approved by 2 different ethics committees.
Type [3] 984 0
Informed consent form
Citation [3] 984 0
Link [3] 984 0
Email [3] 984 0
Other [3] 984 0
Participant information sheet and consent form used at Wellington House and Windana Drug and Alcohol Recovery
Type [4] 985 0
Informed consent form
Citation [4] 985 0
Link [4] 985 0
Email [4] 985 0
Other [4] 985 0
Participant information sheet and consent form used at Depaul House
Type [5] 986 0
Ethical approval
Citation [5] 986 0
Link [5] 986 0
Email [5] 986 0
Other [5] 986 0
Type [6] 987 0
Ethical approval
Citation [6] 987 0
Link [6] 987 0
Email [6] 987 0
Other [6] 987 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary