NCT05794438

Brief Summary

A randomized controlled trial will be conducted to investigate whether a proposed algorithm that adjusts the congruency ratio based on the user's performance and difficulty can enhance the effectiveness of approach bias modification. Methamphetamine users will be recruited and randomized into an algorithm group, a standard group, and a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

March 6, 2023

Last Update Submit

July 17, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cue induced craving for methamphetamine

    The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).

    Baseline

  • Cue induced craving for methamphetamine

    The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).

    Immediately Post-intervention

  • Cue induced craving for methamphetamine

    The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).

    16 week from baseline assesment

Study Arms (3)

Adaptive Approach Bias Modification

EXPERIMENTAL
Behavioral: Adaptive Approach Bias Modification

Static Approach Bias Modification

EXPERIMENTAL
Behavioral: Static Approach Bias Modification

Control

NO INTERVENTION

Interventions

In the static approach bias modification, users were instructed to swipe upward when they see portrait format images and swipe downward when they see landscape format images. A shrinking animation comes after swiping upward to simulate the visual effect of moving away (approach), and a growing animation comes after swiping downward to simulate the visual effect of moving towards (avoidance). Two types of images, namely drug-related and non-drug-related, were used in the training. The drug-related images were related to methamphetamine (methamphetamine crystals, powders, and paraphernalia), and the non-drug-related images were related to healthy lifestyles (wealth, sports, gourmet, family activities, etc).

Static Approach Bias Modification

In the adaptive approach bias modification, users were instructed to swipe upward when they see portrait format images and swipe downward when they see landscape format images. A shrinking animation comes after swiping upward to simulate the visual effect of moving away (approach), and a growing animation comes after swiping downward to simulate the visual effect of moving towards (avoidance). Two types of images, namely drug-related and non-drug-related, were used in the training. The drug-related images were related to methamphetamine (methamphetamine crystals, powders, and paraphernalia), and the non-drug-related images were related to healthy lifestyles (wealth, sports, gourmet, family activities, etc). An algorithm continuously monitors the performance of the user and adjusts the ratio of congruent and incongruent trials accordingly to attain a desired difficulty curve.

Adaptive Approach Bias Modification

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having a history of methamphetamine use of at least one year

You may not qualify if:

  • could not fluently operate an Android or an iOS smartphone
  • having mental health conditions other than MUD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Gao Ping Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Han Zhou Street Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Jin Lun Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Jin Yan Street Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Jin Yu Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Lian Shan Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Nan Feng Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

San Shui Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Sanxingdui Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

SixTwentySix Service Center, Luo Cheng Street, Guanghan City

Luocheng, Sichuan, China

Location

Xiang Yang Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

Xiao Han Town Community Drug Rehabilitation Center

Luocheng, Sichuan, China

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 3, 2023

Study Start

March 10, 2023

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations