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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
30/10/2023
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
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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
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Secondary ID [1]
299900
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National Centre for Clinical Research on Emerging Drugs (NCCRED) project number: NCR2SF10
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Universal Trial Number (UTN)
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Trial acronym
MAAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use disorder
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Drug addiction
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Condition category
Condition code
Mental Health
313623
313623
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
316171
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Treatment: Other
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Self-reported abstinence from methamphetamine for the past 4 weeks, according to the timeline follow-back interview.
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Assessment method [1]
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Timepoint [1]
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3-months following discharge from residential treatment
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Secondary outcome [1]
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Self-reported abstinence from methamphetamine for the first 4 weeks after discharge, according to the timeline follow-back interview.
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Assessment method [1]
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Timepoint [1]
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4-weeks following discharge from residential treatment
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Secondary outcome [2]
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Self-reported continuous abstinence from methamphetamine since discharge, according to single-item question specific to this study.
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Assessment method [2]
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Timepoint [2]
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3-months following discharge from residential treatment
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Secondary outcome [3]
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DSM-5 methamphetamine use disorder diagnosis
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Assessment method [3]
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Timepoint [3]
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3-months following discharge from residential treatment
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Secondary outcome [4]
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Severity of dependence scale score for methamphetamine of 5 or more
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Assessment method [4]
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Timepoint [4]
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4-weeks following discharge from residential treatment and 3-months following discharge from residential treatment
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Secondary outcome [5]
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Self-reported time to first lapse to methamphetamine use, measured using timeline follow-back questionnaire and single-item question specific to this study.
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Assessment method [5]
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Timepoint [5]
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3-months following discharge from residential treatment
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Secondary outcome [6]
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Methamphetamine and positive image approach bias, as measured by reaction times during the approach-avoidance task.
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Assessment method [6]
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Timepoint [6]
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Final session of ABM (or sham) training)
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Secondary outcome [7]
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Severity of dependence scale score
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Assessment method [7]
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Timepoint [7]
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4-weeks following discharge from residential treatment and 3-months following discharge from residential treatment
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Secondary outcome [8]
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Number of DSM-5 methamphetamine use disorder criteria met, according to the Structured Clinical Interview for DSM-5 Disorders – Research Version (SCID-5-RV)
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Assessment method [8]
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Timepoint [8]
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3-months following discharge from residential treatment
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Secondary outcome [9]
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Methamphetamine craving, according to Craving Experience Questionnaire (CEQ) score
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Assessment method [9]
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Timepoint [9]
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final session of training, 4-week follow-up, and 3-month follow-up
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Secondary outcome [10]
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Single-item visual analogue scale methamphetamine craving score
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Assessment method [10]
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Timepoint [10]
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Immediately before and after each session of ABM
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Too physically or mentally impaired to provide informed consent or safely participate in the intervention, according to clinical staff judgement.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
16/03/2020
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Actual
16/03/2020
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Date of last participant enrolment
Anticipated
30/04/2024
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Actual
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Date of last data collection
Anticipated
30/08/2024
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Actual
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Sample size
Target
100
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Accrual to date
20
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
28615
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3004 - St Kilda Road Melbourne
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Recruitment postcode(s) [2]
28614
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3128 - Box Hill
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Recruitment postcode(s) [3]
28616
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3145 - Malvern East
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Funding & Sponsors
Funding source category [1]
304365
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Charities/Societies/Foundations
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Name [1]
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National Centre for Clinical Research on Emerging Drugs
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Address [1]
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22-32 King Street
Randwick, NSW
2031
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Country [1]
304365
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
Wellington Road
Clayton, VIC
3800
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304615
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Country [1]
304615
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Eastern Health Human Research Ethics Committee
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Ethics committee address [1]
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Level 2, 5 Arnold Street Box Hill, VIC 3128
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/11/2019
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Approval date [1]
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07/01/2020
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Ethics approval number [1]
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E19/022/58264
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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.
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Trial website
https://www.turningpoint.org.au/research/impact/Cognitive-Bias-Modification-Methamphetamine
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Victoria Manning
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Address
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
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Australia
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Phone
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+61 3 8413 8724
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Fax
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Email
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victoria.manning@monash.edu
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Contact person for public queries
Name
98275
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Joshua Garfield
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Address
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
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Australia
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Phone
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+61 3 8413 8711
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Fax
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Email
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joshuag@turningpoint.org.au
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Contact person for scientific queries
Name
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Joshua Garfield
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Address
98276
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
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Australia
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Phone
98276
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+61 3 8413 8711
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Fax
98276
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Email
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joshuag@turningpoint.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
From immediately following publication until 7 years afterwards.
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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.
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Available for what types of analyses?
Researchers may propose any analyses, subject to approval by the Eastern Health Human Research Ethics Committee.
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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
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
joshuag@turningpoint.org.au
To be made publicly-available at a later date to a...
[
More Details
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Statistical analysis plan
joshuag@turningpoint.org.au
Not yet available - email Joshua Garfield for furt...
[
More Details
]
Informed consent form
378804-(Uploaded-07-01-2020-14-24-31)-Study-related document.docx
Ethical approval
378804-(Uploaded-07-01-2020-14-24-58)-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
Source
Title
Year of Publication
DOI
Embase
Protocol for the methamphetamine approach-avoidance training (MAAT) trial, a randomised controlled trial of personalised approach bias modification for methamphetamine use disorder.
2021
https://dx.doi.org/10.1186/s13063-020-04927-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
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