Protocol for the methamphetamine approach-avoidance training (MAAT) trial, a randomised controlled trial of personalised approach bias modification for methamphetamine use disorder.

BACKGROUND: Globally, methamphetamine use has increased in prevalence in recent years. In Australia, there has been a dramatic increase in numbers of people seeking treatment, including residential rehabilitation, for methamphetamine use disorder (MUD). While residential rehabilitation is more effective for MUD than withdrawal treatment (i.e. "detoxification") alone, relapse rates remain high, with approximately half of rehabilitation clients using methamphetamine within 3 months of rehabilitation. "Approach bias modification" (ABM) is a computerised cognitive training approach that aims to dampen automatically triggered impulses to approach drugs and drug-related stimuli. ABM has been demonstrated to reduce alcohol relapse rates, but no randomised controlled trials of ABM for MUD have yet been conducted. We aim to test whether a novel "personalised" form of ABM, delivered during rehabilitation, reduces post-treatment methamphetamine use, relative to a sham-training control condition. Secondary outcomes will include dependence symptoms, cravings, and approach bias. METHODS: We aim to recruit 100 participants attending residential rehabilitation for MUD at 3 sites in the Melbourne metropolitan area. Participants will complete baseline measures of methamphetamine use, craving, dependence severity, and approach bias before being randomised to receiving 6 sessions of ABM or "sham" training. In the active condition, ABM will be personalised for each participant, using those methamphetamine images that they rate as most relevant to their recent methods of methamphetamine use as "avoidance" images and using positive images representing their goals or healthy sources of pleasure as "approach" images. Approach bias and craving will be re-assessed following completion of training, and methamphetamine use, dependence, and craving will be assessed 4 weeks and 3 months following discharge from residential treatment. DISCUSSION: This study is the first randomised controlled trial of ABM for MUD and also the first ABM study to test using a personalised set of both approach and avoid images for ABM training. If effective, the low cost and easy implementation of ABM means it could be widely implemented as a standard part of MUD treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000072910. Registered on 30 January 2020 (prospectively registered): https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378804&isReview=true.

Feasibility and acceptability of approach bias modification during methamphetamine withdrawal and related methamphetamine use outcomes.

Approach bias modification (ApBM), a computerised cognitive training task which aims to reduce automatic, impulsive responding to drug-related cues, has been found to reduce alcohol consumption among individuals seeking treatment for their drinking. However, this approach has not been trialled in patients with methamphetamine use disorder (MUD), where altered impulsivity and reward processing are well-established. As such, this study aimed to examine the feasibility and acceptability of four consecutive days of ApBM training during a residential admission for methamphetamine withdrawal. Abstinence rates were examined 2-weeks and 3-months post-discharge. In terms of uptake, 52 of the 99 eligible patients approached agreed to participate and 47 of these 52 commenced training. Uptake and training completion rates (62%) were lower than those achieved in similar trials of ApBM for residential alcohol withdrawal, suggesting there are challenges to its delivery in this setting. This is likely due to the severity of acute methamphetamine withdrawal syndrome and associated behavioural characteristics. However, participants' ratings of the task and reports of post-session craving suggest acceptability was high. Abstinence rates were 61% at 2 weeks and 54% at 3-months, which compare favourably with the abstinence rates observed in a previous large treatment outcome study. The evidence of acceptability and apparent effectiveness suggest future trials of ApBM with MUD patients are warranted. However, ApBM may be more feasible in certain settings or among particular sub-groups where patients are more clinically stable and therefore more likely to complete the training (e.g., residential rehabilitation, after acute withdrawal has subsided).

Protocol for a randomised controlled trial of cognitive bias modification training during inpatient withdrawal from alcohol use disorder.

BACKGROUND: People with alcohol use disorders often exhibit an "alcohol approach bias", the automatically triggered action tendency to approach alcohol. Approach bias is likely to persist following withdrawal from alcohol, and contribute to the high rate of relapse following withdrawal treatment. Cognitive bias modification (CBM) training has been shown to attenuate approach biases and lead to reduced relapse rates. However, no large multisite trial of CBM specifically within a residential withdrawal treatment setting has previously been conducted. This study aims to test whether CBM delivered during residential withdrawal treatment leads to reduced relapse rates and reduced use of acute health services following discharge, and to test possible moderators of CBM's effect on alcohol use. METHODS: Three hundred alcohol-dependent inpatients are being recruited from three withdrawal treatment units in the Melbourne metropolitan area. Participants complete baseline measures of alcohol approach bias and cue-evoked desire for alcohol, followed by four daily sessions of computerised CBM training (or sham training if randomised to the control group). Approach bias and cue-evoked desire are re-assessed following the fourth training session. Follow-up assessments administered 2 weeks and 3, 6, and 12 months following discharge from the withdrawal treatment unit compare abstinence rates and acute and emergency healthcare service use between conditions. Pre-admission and follow-up substance use is derived from the timeline follow-back method, and approach bias towards alcohol with a computerised Approach Avoidance Task. DISCUSSION: This study is the first multisite randomised controlled trial of cognitive bias modification delivered during acute alcohol withdrawal treatment. Withdrawal is theoretically an ideal period to deliver neurocognitive interventions due to heightened neuroplasticity and cognitive recovery. If effective, the low cost and easy implementation of CBM training means it could be widely used as a standard part of alcohol withdrawal treatment to improve treatment outcomes. Moderation analyses may help better determine whether certain subgroups of patients are most likely to benefit from it and therefore should be prioritised for CBM during alcohol withdrawal treatment. TRIAL REGISTRATION: Version 4 of the protocol (dated 1 August 2017) is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001241325 . Registered on 25 August 2017 (retrospectively registered).