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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

3/03/2021

Date data sharing statement initially provided

17/01/2019

Date results 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]

Eastern Health Foundation grant number EHFRG2017_060

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Methamphetamine use disorder

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the time of discharge from the inpatient withdrawal unit.

Primary outcome [2]

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]

Time of withdrawal

Primary outcome [3]

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]

Following completion of ABM training.

Secondary outcome [1]

Uptake, as indexed by the proportion of eligible patients who agree to participate upon being approached and then commence training.

Timepoint [1]

At the time of (attempted) recruitment and commencement of training.

Secondary outcome [2]

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]

Immediately following each of the 4 sessions.

Secondary outcome [3]

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]

2-week follow-up.

Secondary outcome [4]

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]

3-month follow-up.

Secondary outcome [5]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

4/10/2017

Date of last participant enrolment

Anticipated

Actual

21/09/2018

Date of last data collection

Anticipated

Actual

3/01/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3128 - Box Hill

Recruitment postcode(s) [3]

3183 - St Kilda East

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Eastern Health Foundation

Address [1]

5 Arnold Street, Box Hill VIC 3128

Country [1]

Australia

Primary sponsor type

Hospital

Name

Eastern Health

Address

5 Arnold Street, Box Hill VIC 3128

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee

Ethics committee address [1]

Level 2, 5 Arnold Street
Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2017

Approval date [1]

08/05/2017

Ethics approval number [1]

E03-2017

Ethics committee name [2]

Saint Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [2]

41 Victoria Parade, Fitzroy, Victoria, 3065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

16/10/2017

Approval date [2]

30/11/2017

Ethics approval number [2]

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

http://stage.turningpoint.org.au/research/impact/Cognitive-Bias-Modification-Methamphetamine/pilot-study

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Contact person for public queries

Name

Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Contact person for scientific queries

Name

Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Other Details	Attachment
982	Study protocol	Two nearly-identical versions of the protocol were... [More Details]	376674-(Uploaded-09-01-2019-11-50-30)-Study-related document.docx
983	Study protocol	Two nearly-identical versions of the protocol were... [More Details]	376674-(Uploaded-09-01-2019-11-50-47)-Study-related document.docx
984	Informed consent form	Participant information sheet and consent form use... [More Details]	376674-(Uploaded-09-01-2019-11-51-27)-Study-related document.docx
985	Informed consent form	Participant information sheet and consent form use... [More Details]	376674-(Uploaded-09-01-2019-11-51-40)-Study-related document.docx
986	Ethical approval		376674-(Uploaded-09-01-2019-11-57-43)-Study-related document.pdf
987	Ethical approval		376674-(Uploaded-09-01-2019-11-57-57)-Study-related document.pdf

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.

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