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Trial registered on ANZCTR


Registration number
ACTRN12620000072910
Ethics application status
Approved
Date submitted
7/01/2020
Date registered
30/01/2020
Date last updated
30/07/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The methamphetamine approach-avoidance training (MAAT) trial: a study of whether approach bias modification can reduce methamphetamine use after rehabilitation
Scientific title
A pilot randomised controlled trial (RCT) testing the effect of personalised approach bias modification (vs. sham training) on abstinence from methamphetamine following discharge from rehabilitation in patients undergoing residential treatment for methamphetamine use disorder
Secondary ID [1] 299900 0
National Centre for Clinical Research on Emerging Drugs (NCCRED) project number: NCR2SF10
Universal Trial Number (UTN)
Trial acronym
MAAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use disorder 315321 0
Drug addiction 315907 0
Condition category
Condition code
Mental Health 313623 313623 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The approach bias modification (ABM) intervention will involve 6 sessions, each lasting approximately 15 minutes. There will be 240 trials per session, in which images will be presented surrounded by a rectangular “frame” (i.e., a black rectangle surrounding the image) which will be in either “portrait” or “landscape” orientation. Participants will be instructed to “push” the joystick in response to pictures with a landscape-oriented frame and “pull” in response to pictures with a portrait-oriented frame. Push and pull responses will cause the image to shrink and expand, respectively, creating the impression of avoidance and approach. Each session will be preceded by a display of the task instructions, followed by 8 practice trials in which participants will respond to empty rectangles (4 in landscape and 4 in portrait orientation), to ensure they are familiar with the task instructions before commencing the training trials. During both practice and training trials, if participants make an incorrect response (i.e., move the joystick to its maximum extent in the incorrect direction), a red ‘x’ will be displayed and they will be required to repeat that trial.

Further details of the ABM condition are currently hidden to maintain blinding, but will be revealed upon completion of the study. Training sessions will be supervised by a research assistant who will assist with explaining task instructions and remain present during the session in case of technical problems or if the participant becomes distressed. The first session of ABM will not be conducted until the participant has been in residential treatment for at least 7 days, to minimise the degree to which acute withdrawal symptoms (e.g., fatigue, emotional lability) interfere with engagement in the training task. ABM will be repeated 3 times per week for 2 weeks, for a total of 6 sessions. There will be flexibility regarding frequency of sessions to try to ensure that as many participants as possible complete 6 sessions prior to discharge. For example, if a session is missed due to participant illness, additional sessions can be scheduled more than 2 weeks after the first session if 6 have not yet been completed at that point, or more than 3 sessions can be conducted in a week if the participant is not staying longer (or if their planned discharge is moved to an earlier date). However, only one session will ever be administered per day (i.e., multiple training sessions will not be conducted on the same day).
Intervention code [1] 316171 0
Treatment: Other
Comparator / control treatment
The general procedure for sham training sessions is the same as that for ABM sessions. Specific details of how the sham condition differs from the ABM condition are currently hidden to maintain blinding, but will be revealed upon completion of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 322068 0
Self-reported abstinence from methamphetamine for the past 4 weeks, according to the timeline follow-back interview.
Timepoint [1] 322068 0
3-months following discharge from residential treatment
Secondary outcome [1] 377209 0
Self-reported abstinence from methamphetamine for the first 4 weeks after discharge, according to the timeline follow-back interview.
Timepoint [1] 377209 0
4-weeks following discharge from residential treatment
Secondary outcome [2] 377211 0
Self-reported continuous abstinence from methamphetamine since discharge, according to single-item question specific to this study.
Timepoint [2] 377211 0
3-months following discharge from residential treatment
Secondary outcome [3] 377212 0
DSM-5 methamphetamine use disorder diagnosis
Timepoint [3] 377212 0
3-months following discharge from residential treatment
Secondary outcome [4] 377213 0
Severity of dependence scale score for methamphetamine of 5 or more
Timepoint [4] 377213 0
4-weeks following discharge from residential treatment and 3-months following discharge from residential treatment
Secondary outcome [5] 377214 0
Self-reported time to first lapse to methamphetamine use, measured using timeline follow-back questionnaire and single-item question specific to this study.
Timepoint [5] 377214 0
3-months following discharge from residential treatment
Secondary outcome [6] 377215 0
Methamphetamine and positive image approach bias, as measured by reaction times during the approach-avoidance task.
Timepoint [6] 377215 0
Final session of ABM (or sham) training)
Secondary outcome [7] 377216 0
Severity of dependence scale score
Timepoint [7] 377216 0
4-weeks following discharge from residential treatment and 3-months following discharge from residential treatment
Secondary outcome [8] 377217 0
Number of DSM-5 methamphetamine use disorder criteria met, according to the Structured Clinical Interview for DSM-5 Disorders – Research Version (SCID-5-RV)
Timepoint [8] 377217 0
3-months following discharge from residential treatment
Secondary outcome [9] 377223 0
Methamphetamine craving, according to Craving Experience Questionnaire (CEQ) score
Timepoint [9] 377223 0
final session of training, 4-week follow-up, and 3-month follow-up
Secondary outcome [10] 377224 0
Single-item visual analogue scale methamphetamine craving score
Timepoint [10] 377224 0
Immediately before and after each session of ABM

Eligibility
Key inclusion criteria
1. Aged at least 18 years.
2. Moderate/severe methamphetamine use disorder (MUD), according to Diagnostic and Statistical Manual (DSM-5) (American Psychiatric Association, 2013) criteria (i.e., meeting >4 criteria).
3. Used methamphetamine on at least 4 of the 28 days prior to commencing residential treatment.
4. Sufficient English language proficiency to understand the participant information sheet, questionnaires, and intervention task instructions.
5. Able to provide a phone number for follow-ups.
6. Intending to stay in the residential setting long enough to complete the training protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too physically or mentally impaired to provide informed consent or safely participate in the intervention, according to clinical staff judgement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur automatically at the time participants commence their first session of ABM. The randomisation sequences will be stored within a database on a password-protected server. The program’s access to these data will be automated and manual access to the database will be limited to the programmer, chief investigator, and a statistician not involved in data collection. A local copy of the randomisation sequence stored on the computer will be encrypted to prevent accidental unblinding. This is to prevent staff involved in recruitment at sites from knowing what condition a participant will be assigned to prior to them commencing the first ABM session, and to prevent staff involved in conducting follow-ups from becoming unblinded to participant condition prior to assessing outcomes. When participants commence an ABM session, the researcher will enter the participant’s number, and the ABM program will query the database (or the local copy, if there is no internet connection) to determine the condition associated with that number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence detailing which participant numbers will be assigned to which condition will be programmed into each laptop computer, using a 1:1 allocation ratio in blocks of 6. Since separate laptops will be used for each recruitment site, randomisation will therefore be stratified by site. Randomisation sequences will be generated by the computer programmer responsible for programming the ABM tasks prior to commencing the study. These sequences will be determined by repeatedly sampling at random without replacement from a 10-length vector proportioned equally between each condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome (past-month abstinence) will be tested using Pearson’s chi square tests comparing proportions reporting abstinence in each group at each follow-up. Pearson’s chi square tests will also be used to test continuous abstinence since discharge and categorical measures of MUD (i.e. SCID-5-RV MUD; SDS score of 5 or more). Time to first lapse will be compared between groups using Cox regression analysis. Change in approach bias (between the beginning and end of training), CEQ score (between baseline, post-training, 1-month, and 3-month follow-ups), SDS score (between baseline, 1-month, and 3-month follow-up), and number of SCID criteria met (between baseline and 3-month follow-up), will be compared between groups using repeated measures analysis of variance.

The primary analyses will be conducted on an intention-to-treat basis, whereby attempts will be made to follow-up everyone who commences a single session of training. Missing outcomes (i.e. from those lost to follow-up) will not be imputed in the primary analysis, though supplementary sensitivity analyses of past-month and continuous abstinence will be conducted in which we will assume all those lost to follow-up used methamphetamine. Additional “per-protocol” supportive analyses will be restricted to participants who completed at least 4 full sessions of training, and to those who completed all 6 sessions.

Recruitment
Recruitment status
Recruiting
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 postcode(s) [1] 28614 0
3128 - Box Hill
Recruitment postcode(s) [2] 28615 0
3004 - St Kilda Road Melbourne
Recruitment postcode(s) [3] 28616 0
3145 - Malvern East

Funding & Sponsors
Funding source category [1] 304365 0
Charities/Societies/Foundations
Name [1] 304365 0
National Centre for Clinical Research on Emerging Drugs
Address [1] 304365 0
22-32 King Street
Randwick, NSW
2031
Country [1] 304365 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, VIC
3800
Country
Australia
Secondary sponsor category [1] 304615 0
None
Name [1] 304615 0
Address [1] 304615 0
Country [1] 304615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304806 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 304806 0
Level 2, 5 Arnold Street
Box Hill, VIC
3128
Ethics committee country [1] 304806 0
Australia
Date submitted for ethics approval [1] 304806 0
01/11/2019
Approval date [1] 304806 0
07/01/2020
Ethics approval number [1] 304806 0
E19/022/58264

Summary
Brief summary
Approximately half of those attending residential rehabilitation for methamphetamine use disorder (MUD) use methamphetamine within 3-months of leaving rehabilitation. One factor associated with relapse following residential treatment is “approach bias” – easily-triggered impulses to approach drug-related stimuli, and to seek drugs in response to these stimuli. Approach bias develops after frequent drug use, but studies in people with alcohol use disorders (including our own research) suggest that approach bias can be reduced through computerised training known as “approach bias modification” (ABM), which also reduces likelihood of relapse. However, aside from our small open-label feasibility study with methamphetamine withdrawal patients, this approach has not been trialed in people seeking treatment for MUD. Moreover, the approach of seeking to increase the efficacy of ABM by personalising the stimuli used in ABM training (e.g. to match the specific forms of drugs and route of administration that individual clients use), has not been trialed for any substance so far.

We intend to commence a pilot RCT to test a 2-week course of personalised ABM (3 sessions per week). Patients with MUD will be randomised to receive either personalised ABM or a sham training control condition. Participants will be followed up 1- and 3-months post-discharge from rehabilitation to determine whether personalised ABM reduces methamphetamine use, craving, MUD symptoms, and methamphetamine approach bias, relative to patients who receive “sham” training.
Trial website
https://www.turningpoint.org.au/research/impact/Cognitive-Bias-Modification-Methamphetamine
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98274 0
A/Prof Victoria Manning
Address 98274 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 98274 0
Australia
Phone 98274 0
+61 3 8413 8724
Fax 98274 0
Email 98274 0
victoria.manning@monash.edu
Contact person for public queries
Name 98275 0
Dr Joshua Garfield
Address 98275 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 98275 0
Australia
Phone 98275 0
+61 3 8413 8711
Fax 98275 0
Email 98275 0
joshuag@turningpoint.org.au
Contact person for scientific queries
Name 98276 0
Dr Joshua Garfield
Address 98276 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 98276 0
Australia
Phone 98276 0
+61 3 8413 8711
Fax 98276 0
Email 98276 0
joshuag@turningpoint.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified participant data (both questionnaire data and computer task performance data) may be made available to other researchers upon reasonable request to the principal investigator, and only following further approval from the Eastern Health Human Research Ethics Committee.
When will data be available (start and end dates)?
From immediately following publication until 7 years afterwards.
Available to whom?
Data will be made available to other researchers upon reasonable request to the principal investigator, and only following further approval from the Eastern Health Human Research Ethics Committee.
Available for what types of analyses?
Researchers may propose any analyses, subject to approval by the Eastern Health Human Research Ethics Committee.
How or where can data be obtained?
Researchers wishing to access individual-level data will need to contact the principal investigator, Victoria Manning, by emailing victoria.manning@monash.edu
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5854 0
Study protocol
Citation [1] 5854 0
Link [1] 5854 0
Email [1] 5854 0
joshuag@turningpoint.org.au
Other [1] 5854 0
To be made publicly-available at a later date to avoid unblinding participants by making details of training conditions public.
Attachment [1] 5854 0
Type [2] 5855 0
Statistical analysis plan
Citation [2] 5855 0
Link [2] 5855 0
Email [2] 5855 0
joshuag@turningpoint.org.au
Other [2] 5855 0
Not yet available - email Joshua Garfield for further information
Attachment [2] 5855 0
Type [3] 5856 0
Informed consent form
Citation [3] 5856 0
Link [3] 5856 0
Email [3] 5856 0
Other [3] 5856 0
Type [4] 5857 0
Ethical approval
Citation [4] 5857 0
Link [4] 5857 0
Email [4] 5857 0
Other [4] 5857 0
Summary results
No Results