- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794438
Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History
July 17, 2023 updated by: Adai Technology (Beijing) Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Guanghan, Sichuan, China
- Gao Ping Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- Han Zhou Street Community Drug Rehabilitation Center
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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
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Guanghan, Sichuan, China
- Lian Shan Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- Nan Feng Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- San Shui Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- Sanxingdui Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- SixTwentySix Service Center, Luo Cheng Street, Guanghan City
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Guanghan, Sichuan, China
- Xiang Yang Town Community Drug Rehabilitation Center
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Guanghan, Sichuan, China
- Xiao Han Town Community Drug Rehabilitation Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: 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.
|
|
Experimental: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cue induced craving for methamphetamine
Time Frame: Baseline
|
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
Time Frame: Immediately Post-intervention
|
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
Time Frame: 16 week from baseline assesment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2023
Primary Completion (Actual)
July 15, 2023
Study Completion (Actual)
July 15, 2023
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TS001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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