Addiction, SubstanceNCT05794438
Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History
A study testing Static Approach Bias Modification and Adaptive Approach Bias Modification in people with Addiction, Substance, run by Adai Technology (Beijing) Co., Ltd. at 12 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Addiction, Substance
- What is being tested?
- Static Approach Bias Modification and Adaptive Approach Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 12 sitesChina
- Study dates
- 10 Mar 2023to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having a history of methamphetamine use of at least one year
Who cannot join
- could not fluently operate an Android or an iOS smartphone
- having mental health conditions other than MUD
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Gao Ping Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Han Zhou Street Community Drug Rehabilitation Center
Luocheng, Sichuan
Jin Lun Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Jin Yan Street Community Drug Rehabilitation Center
Luocheng, Sichuan
Jin Yu Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Lian Shan Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Nan Feng Town Community Drug Rehabilitation Center
Luocheng, Sichuan
San Shui Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Sanxingdui Town Community Drug Rehabilitation Center
Luocheng, Sichuan
SixTwentySix Service Center, Luo Cheng Street, Guanghan City
Luocheng, Sichuan
Xiang Yang Town Community Drug Rehabilitation Center
Luocheng, Sichuan
Xiao Han Town Community Drug Rehabilitation Center
Luocheng, Sichuan
About this study
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.
Read the 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.
- Conditions
- Addiction, Substance
- Being tested
- Static Approach Bias Modification, Adaptive Approach Bias Modification
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Approach Bias ModificationBehavioural
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 ModificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Approach Bias Modification | Experimental | Not described Receives: Behavioral: Adaptive Approach Bias Modification |
| Static Approach Bias Modification | Experimental | Not described Receives: Behavioral: Static Approach Bias Modification |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 16 week from baseline assesment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start10 Mar 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction, SubstanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794438
- Sponsor's protocol ID
- TS001
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History
- ClinicalTrials.gov ID
- NCT05794438
- Acronym / sponsor ID
- TS001
- Conditions
- Addiction, Substance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.University, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptive Approach Bias Modification | Experimental | Behavioral: Adaptive Approach Bias Modification |
| Static Approach Bias Modification | Experimental | Behavioral: Static Approach Bias Modification |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- having a history of methamphetamine use of at least one year
Key exclusion criteria (2 listed)
- could not fluently operate an Android or an iOS smartphone
- having mental health conditions other than MUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static Approach Bias ModificationIn 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). | Behavioural | Static Approach Bias Modification |
| Adaptive Approach Bias ModificationIn 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. | Behavioural | Adaptive Approach Bias Modification |
Primary outcome
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Approach Bias Modification and Adaptive Approach Bias Modification in people with Addiction, Substance, run by Adai Technology (Beijing) Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue induced craving for methamphetamine (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.