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OpenTrials
Completed

NCT Number: NCT07319325

Efficacy of Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation

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.

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Key information

Conditions

Methamphetamine Addiction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Rehabilitation Centers

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 60 years.
  • Currently enrolled in a community rehabilitation program.
  • Ability to fluently operate a smartphone (Android or iOS).

Exclusion criteria

  • Presence of a severe mental health condition (e.g., schizophrenia, bipolar I disorder) requiring acute psychiatric care.
  • Inability to provide informed consent.

Treatment and study plan

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 Counseling

Behavioral

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.

Primary outcomes

  1. Change in Cue-Induced Craving Score

    Time frame: Baseline and 8 Weeks (Post-intervention)

    Self-reported craving elicited by standardized methamphetamine-related images, measured using a Visual Analog Scale (VAS). Scores range from 0 to 100, with higher scores indicating higher craving. The outcome is defined as the change in score from Baseline to Week 8.

Sponsors and collaborators

Lead sponsor

Adai Technology (Beijing) Co., Ltd.

Other

Registry information

Official study title

Efficacy of an Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation: A Pragmatic Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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