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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Guanghan, Sichuan, 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Adaptive Approach Bias Modification
Behavioral: 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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adai Technology (Beijing) Co., Ltd.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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