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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05794438
Other study ID # TS001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date July 15, 2023

Study information

Verified date July 2023
Source Adai Technology (Beijing) Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

To assess the efficacy of an adaptive approach bias modification (A-ApBM) paradigm with gamified designs and dynamic difficulty adjustments in reducing cue-induced craving in individuals with methamphetamine use history. DESIGN: Randomized controlled trial with three study groups: Adaptive ApBM (A-ApBM), Static ApBM (S-ApBM), and control. A-ApBM and S-ApBM groups engaged in ApBM training using a smartphone application for four weeks. A-ApBM used an adaptive algorithm to dynamically adjust the difficulty level based on individual performance, while S-ApBM had a static difficulty level. Cue-induced craving scores were assessed using a visual analog scale at baseline, post-intervention, and at week-16 follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date July 15, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: • having a history of methamphetamine use of at least one year Exclusion Criteria: - could not fluently operate an Android or an iOS smartphone - having mental health conditions other than MUD

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Static Approach Bias Modification
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).
Adaptive 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.

Locations

Country Name City State
China Gao Ping Town Community Drug Rehabilitation Center Guanghan Sichuan
China Han Zhou Street Community Drug Rehabilitation Center Guanghan Sichuan
China Jin Lun Town Community Drug Rehabilitation Center Guanghan Sichuan
China Jin Yan Street Community Drug Rehabilitation Center Guanghan Sichuan
China Jin Yu Town Community Drug Rehabilitation Center Guanghan Sichuan
China Lian Shan Town Community Drug Rehabilitation Center Guanghan Sichuan
China Nan Feng Town Community Drug Rehabilitation Center Guanghan Sichuan
China San Shui Town Community Drug Rehabilitation Center Guanghan Sichuan
China Sanxingdui Town Community Drug Rehabilitation Center Guanghan Sichuan
China SixTwentySix Service Center, Luo Cheng Street, Guanghan City Guanghan Sichuan
China Xiang Yang Town Community Drug Rehabilitation Center Guanghan Sichuan
China Xiao Han Town Community Drug Rehabilitation Center Guanghan Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Adai Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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