Methamphetamine AddictionNCT07319325
Efficacy of Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation
A study testing WonderLab Harbor+ (Adaptive DTx) and Standard Community Counseling in people with Methamphetamine Addiction, run by Adai Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving community-based rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Methamphetamine Addiction
- What is being tested?
- WonderLab Harbor+ (Adaptive DTx) and Standard Community Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 2 Nov 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Currently enrolled in a community rehabilitation program.
- Ability to fluently operate a smartphone (Android or iOS).
Who cannot join
- Presence of a severe mental health condition (e.g., schizophrenia, bipolar I disorder) requiring acute psychiatric care.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation: A Pragmatic Randomized Controlled Trial
This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving community-based rehabilitation. The intervention integrates Internet-based Cognitive Behavioral Therapy (ICBT), adaptive Approach Bias Modification (A-ApBM), cognitive training, and contingency management. The primary hypothesis is that the DTx intervention will result in a greater reduction in cue-induced craving compared to standard community care.
Read the detailed description
Methamphetamine Use Disorder (MUD) lacks effective pharmacotherapies, and traditional psychosocial interventions face scalability challenges in community settings. This pragmatic randomized controlled trial (RCT) aims to assess a smartphone-based digital therapeutic intervention designed to overcome these barriers.
Participants recruited from 12 community rehabilitation centers in Sichuan, China, are randomized 1:1 to either the DTx group or the Treatment as Usual (TAu) group.
The DTx group uses a smartphone application ("WonderLab Harbor+") for 8 weeks as an adjunct to standard care. The app includes:
- Weekly Internet-based CBT sessions.
- Daily Adaptive Approach Bias Modification (A-ApBM) training, which dynamically adjusts difficulty based on performance.
- Gamified cognitive function training.
- A contingency management system rewarding adherence.
The TAu group receives standard counseling services provided by community social workers. The primary outcome is the change in self-reported cue-induced craving from baseline to 8 weeks.
- Conditions
- Methamphetamine Addiction
- Being tested
- WonderLab Harbor+ (Adaptive DTx), Standard Community Counseling
- Keywords
- Digital Therapeutics, Cognitive Bias Modification, Approach Bias Modification, Community Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WonderLab Harbor+ (Adaptive DTx)Device
Participants receive access to a smartphone application for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care.
Standard Community CounselingBehavioural
Participants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Digital Therapeutics (DTx) | Experimental | Participants receive access to WonderLab Harbor+ (Adaptive DTx), a smartphone application, for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care. Receives: Device: WonderLab Harbor+ (Adaptive DTx) |
| Treatment as Usual (TAU) | Active comparator | Participants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression. Receives: Behavioral: Standard Community Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cue-Induced Craving Score
Cue-induced methamphetamine craving was assessed using a standardized set of 30 methamphetamine-related images presented individually in the smartphone application. Participants rated craving for each image on a visual analogue scale (VAS) from 0 to 100. The mean of the 30 ratings was used as the composite craving score; higher scores indicate greater craving. The outcome is the change in composite craving score from baseline to Week 8.
Measured: Baseline and 8 Weeks (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jun 2025
- Primary completion2 Nov 2025
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine AddictionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 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
- NCT07319325
- Sponsor's protocol ID
- JK2025
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request to the corresponding author.
Publications
Zhang L, Li N, Li Y, Zhang T, Li D, Liu Y, Liu X, Hao W. Preliminary efficacy of a digital therapeutics smartphone application for methamphetamine use disorder: An experimental study. Front Psychiatry. 2022 Oct 19;13:1027695. doi: 10.3389/fpsyt.2022.1027695. eCollection 2022.
PubMed 36339836Shen D, Jiao J, Zhang L, Liu Y, Liu X, Li Y, Zhang T, Li D, Hao W. Gamified Adaptive Approach Bias Modification in Individuals With Methamphetamine Use History From Communities in Sichuan: Pilot Randomized Controlled Trial. JMIR Serious Games. 2025 Mar 10;13:e56978. doi: 10.2196/56978.
PubMed 40063843
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07319325
- Acronym / sponsor ID
- JK2025
- Conditions
- Methamphetamine Addiction
- Keywords
- Digital Therapeutics, Cognitive Bias Modification, Approach Bias Modification, Community Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.University, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 6 Jan 2026 (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.
This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving community-based rehabilitation. The intervention integrates Internet-based Cognitive Behavioral Therapy (ICBT), adaptive Approach Bias Modification (A-ApBM), cognitive training, and contingency management. The primary hypothesis is that the DTx intervention will result in a greater reduction in cue-induced craving compared to standard community care.
Detailed description
Methamphetamine Use Disorder (MUD) lacks effective pharmacotherapies, and traditional psychosocial interventions face scalability challenges in community settings. This pragmatic randomized controlled trial (RCT) aims to assess a smartphone-based digital therapeutic intervention designed to overcome these barriers.
Participants recruited from 12 community rehabilitation centers in Sichuan, China, are randomized 1:1 to either the DTx group or the Treatment as Usual (TAu) group.
The DTx group uses a smartphone application ("WonderLab Harbor+") for 8 weeks as an adjunct to standard care. The app includes:
- Weekly Internet-based CBT sessions.
- Daily Adaptive Approach Bias Modification (A-ApBM) training, which dynamically adjusts difficulty based on performance.
- Gamified cognitive function training.
- A contingency management system rewarding adherence.
The TAu group receives standard counseling services provided by community social workers. The primary outcome is the change in self-reported cue-induced craving from baseline to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Digital Therapeutics (DTx) | Experimental | Device: WonderLab Harbor+ (Adaptive DTx)Participants receive access to WonderLab Harbor+ (Adaptive DTx), a smartphone application, for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Standard Community CounselingParticipants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years.
- Currently enrolled in a community rehabilitation program.
- Ability to fluently operate a smartphone (Android or iOS).
Key exclusion criteria (2 listed)
- Presence of a severe mental health condition (e.g., schizophrenia, bipolar I disorder) requiring acute psychiatric care.
- Inability to provide informed consent.
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 |
|---|---|---|
| WonderLab Harbor+ (Adaptive DTx)Participants receive access to a smartphone application for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care. | Device | Adaptive Digital Therapeutics (DTx) |
| Standard Community CounselingParticipants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in Cue-Induced Craving Score
Time frame: Baseline and 8 Weeks (Post-intervention)
Cue-induced methamphetamine craving was assessed using a standardized set of 30 methamphetamine-related images presented individually in the smartphone application. Participants rated craving for each image on a visual analogue scale (VAS) from 0 to 100. The mean of the 30 ratings was used as the composite craving score; higher scores indicate greater craving. The outcome is the change in composite craving score from baseline to Week 8.
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 29 Oct 2026.
- Results publication: PubMed 36339836Zhang L, Li N, Li Y, Zhang T, Li D, Liu Y, Liu X, Hao W. Preliminary efficacy of a digital therapeutics smartphone application for methamphetamine use disorder: An experimental study. Front Psychiatry. 2022 Oct 19;13:1027695. doi: 10.3389/fpsyt.2022.1027695. eCollection 2022.
- Results publication: PubMed 40063843Shen D, Jiao J, Zhang L, Liu Y, Liu X, Li Y, Zhang T, Li D, Hao W. Gamified Adaptive Approach Bias Modification in Individuals With Methamphetamine Use History From Communities in Sichuan: Pilot Randomized Controlled Trial. JMIR Serious Games. 2025 Mar 10;13:e56978. doi: 10.2196/56978.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request to the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WonderLab Harbor+ (Adaptive DTx) and Standard Community Counseling in people with Methamphetamine Addiction, run by Adai Technology (Beijing) Co., Ltd. at 1 site 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 3 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Cue-Induced Craving Score (time frame: Baseline and 8 Weeks (Post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319325, which also lists 2 linked publications.
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 29 Oct 2026.