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Clinical Trials/NCT05550493
NCT05550493
Completed
Not Applicable

Preliminary Efficacy of a Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Adai Technology (Beijing) Co., Ltd.1 site in 1 country100 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Methamphetamine Abuse
Sponsor
Adai Technology (Beijing) Co., Ltd.
Enrollment
100
Locations
1
Primary Endpoint
Cue induced craving for methamphetamine
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

One hundred participants were recruited and randomized into a digital therapeutics (DTx) group (n=52) and a treatment as usual (TAU) group (n=48). The DTx group used a smartphone application to deliver cognitive behavioral therapy, approach bias modification, cognitive training, and contingency management for eight weeks. The TAU group received counseling from social workers and psychoterapists. Cue-induced craving, cognitive functions, PHQ-9, and GAD-7 were measured at baseline and post-intervention.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • currently undergoing community-based rehabilitation were recruited voluntarily from four community
  • meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence.

Exclusion Criteria

  • could not fluently operate an Android or an iOS smartphone
  • having mental health conditions other than MUD

Outcomes

Primary Outcomes

Cue induced craving for methamphetamine

Time Frame: immediately after the intervetion

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).

Cognitive Function Score

Time Frame: immediately after the intervetion

We use the Meaningless Figure Recognition Test (MFRT) to assess the cognitive function score. This test has eight blocks, and each block has two phases. In the first phase, the participant is presented with a series of meaningless figures one by one for three seconds. The participants were asked to memorize these figures. In the second phase, the previously presented meaningless figures and the same number of the novel meaningless figures are presented on one screen in random order. The participants were asked to recall their memory and click all the previously presented figures within 15 seconds. The correct rate of clicks is used for measuring the cognitive function scores.

Secondary Outcomes

  • PHQ-9(immediately after the intervetion)
  • GAD-7(immediately after the intervetion)

Study Sites (1)

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