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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 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?
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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.
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Secondary ID [1]
297003
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Eastern Health Foundation grant number EHFRG2017_060
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use disorder
310973
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Condition category
Condition code
Mental Health
309636
309636
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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
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.
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Intervention code [1]
313279
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Behaviour
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Intervention code [2]
313280
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportion of participants who complete the 4-session ABM protocol (as a proportion of those who commence at least 1 session of training)
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Assessment method [1]
318594
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Timepoint [1]
318594
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At the time of discharge from the inpatient withdrawal unit.
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Primary outcome [2]
318595
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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.
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Assessment method [2]
318595
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Timepoint [2]
318595
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Time of withdrawal
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Primary outcome [3]
318596
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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.
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Assessment method [3]
318596
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Timepoint [3]
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Following completion of ABM training.
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Secondary outcome [1]
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Uptake, as indexed by the proportion of eligible patients who agree to participate upon being approached and then commence training.
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Assessment method [1]
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Timepoint [1]
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At the time of (attempted) recruitment and commencement of training.
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Secondary outcome [2]
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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).
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Assessment method [2]
365480
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Timepoint [2]
365480
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Immediately following each of the 4 sessions.
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Secondary outcome [3]
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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.
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Assessment method [3]
365482
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Timepoint [3]
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2-week follow-up.
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Secondary outcome [4]
365483
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Proportion of participants reporting past-month abstinence from methamphetamine at the 3-month follow-up, as self-reported during the timeline follow-back interview.
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Assessment method [4]
365483
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Timepoint [4]
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3-month follow-up.
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Secondary outcome [5]
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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.
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Assessment method [5]
365484
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Timepoint [5]
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3-month follow-up.
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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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
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
4/10/2017
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Date of last participant enrolment
Anticipated
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Actual
21/09/2018
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Date of last data collection
Anticipated
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Actual
3/01/2019
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Sample size
Target
50
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Accrual to date
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Final
47
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12875
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [2]
12876
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Box Hill Hospital - Box Hill
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Recruitment postcode(s) [1]
25315
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3065 - Fitzroy
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Recruitment postcode(s) [2]
25316
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3128 - Box Hill
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Recruitment postcode(s) [3]
25317
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3183 - St Kilda East
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Funding & Sponsors
Funding source category [1]
301574
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Charities/Societies/Foundations
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Name [1]
301574
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Eastern Health Foundation
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Address [1]
301574
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5 Arnold Street, Box Hill VIC 3128
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Country [1]
301574
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Australia
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Primary sponsor type
Hospital
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Name
Eastern Health
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Address
5 Arnold Street, Box Hill VIC 3128
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Country
Australia
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Secondary sponsor category [1]
301279
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None
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Name [1]
301279
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Address [1]
301279
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Country [1]
301279
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302303
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Eastern Health Human Research Ethics Committee
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Ethics committee address [1]
302303
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Level 2, 5 Arnold Street
Box Hill VIC 3128
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Ethics committee country [1]
302303
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Australia
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Date submitted for ethics approval [1]
302303
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28/02/2017
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Approval date [1]
302303
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08/05/2017
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Ethics approval number [1]
302303
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E03-2017
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Ethics committee name [2]
302310
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Saint Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [2]
302310
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41 Victoria Parade, Fitzroy, Victoria, 3065
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Ethics committee country [2]
302310
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Australia
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Date submitted for ethics approval [2]
302310
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16/10/2017
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Approval date [2]
302310
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30/11/2017
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Ethics approval number [2]
302310
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207/17
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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.
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Trial website
http://stage.turningpoint.org.au/research/impact/Cognitive-Bias-Modification-Methamphetamine/pilot-study
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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
89754
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
89754
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Australia
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Phone
89754
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+61 3 8413 8724
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Fax
89754
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Email
89754
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[email protected]
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Contact person for public queries
Name
89755
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A/Prof Victoria Manning
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Address
89755
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
89755
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Australia
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Phone
89755
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+61 3 8413 8724
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Fax
89755
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Email
89755
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[email protected]
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Contact person for scientific queries
Name
89756
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A/Prof Victoria Manning
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Address
89756
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Turning Point
110 Church Street
Richmond, Victoria
3121
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Country
89756
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Australia
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Phone
89756
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+61 3 8413 8724
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Fax
89756
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Email
89756
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
982
Study protocol
Two nearly-identical versions of the protocol were...
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More Details
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376674-(Uploaded-09-01-2019-11-50-30)-Study-related document.docx
983
Study protocol
Two nearly-identical versions of the protocol were...
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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
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376674-(Uploaded-09-01-2019-11-51-27)-Study-related document.docx
985
Informed consent form
Participant information sheet and consent form use...
[
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Manning, V., Garfield, J. B. B., Mroz, K., Campbel...
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Other files
No
Manning, V., Garfield, J. B. B., Staiger, P., Hall...
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Other files
No
Manning, V., Garfield, J. B. B., & Lubman, D. I. (...
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Other files
No
Mroz, K., Campbell, S., Garfield, J. B. B., & Mann...
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Plain language summary
No
Many people relapse after treatment for dependence...
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Documents added automatically
No additional documents have been identified.
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