RecruitingACTRN12620000072910

The methamphetamine approach-avoidance training (MAAT) trial: a study of whether approach bias modification can reduce methamphetamine use after rehabilitation

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

Sponsor

Monash University

Enrollment

100 participants

Start Date

Mar 16, 2020

Study Type

Interventional

Conditions

Drug addiction

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Methamphetamine addiction is one of the hardest substance use disorders to treat, with roughly half of people who complete residential rehabilitation returning to use within three months. One reason for this high relapse rate is a phenomenon called 'approach bias' — an automatic, hard-to-control pull towards drug-related cues that can trigger craving and drug-seeking behaviour. This study tests a computerised training program designed to reduce approach bias and, in turn, reduce the chances of relapse. Participants in residential rehabilitation are randomly assigned to receive either personalised approach bias modification (ABM) training — a computer task that trains the brain to 'avoid' drug-related images — or a sham (inactive) version of the training. The training runs three times a week for two weeks. Participants are then followed up one and three months after leaving rehabilitation to compare methamphetamine use, craving, and symptoms between the two groups. You may be eligible if you are 18 or older, have been diagnosed with moderate-to-severe methamphetamine use disorder, used methamphetamine on at least 4 of the 28 days before entering rehabilitation, speak English well enough to understand the tasks, and are planning to complete the full residential treatment program.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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).

Locations(1)

VIC, Australia

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ACTRN12620000072910