NCT07221396

Brief Summary

The goal of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a digital intervention called LDART in adults with stimulant use disorder.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

October 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 29, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

October 23, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

social supportdigital interventionmutual-help groupsstimulant use disorderaddiction recovery

Outcome Measures

Primary Outcomes (5)

  • Recruitment rate

    The percentage of eligible participants who are enrolled relative to the total number of eligible potential participants who completed the screening.

    From enrollment to the final assessment time point (Day 56)

  • Accrual rate

    The rate of enrollment, defined as number of participants enrolled per month.

    From enrollment to the final assessment time point (Day 56)

  • Retention rate

    The percentage of enrolled participants who complete all study-related procedures (i.e., all three assessments).

    From enrollment to the final assessment time point (Day 56)

  • Intervention engagement

    Number of nights enrolled participants completed the activities on the LDART website, out of 28 nights.

    From beginning the intervention (Day 1) to the end of the intervention period (Day 28)

  • Intervention acceptability

    Rating scores on the end-user version of the Mobile App Rating Scale (uMARS). Total score range 1-5 with higher scores indicating a better quality app.

    The second assessment time point (post-intervention, Day 28)

Secondary Outcomes (2)

  • Change from baseline in stimulant use frequency

    Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

  • Change from baseline in number of hours spent engaging with recovery groups

    Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

Study Arms (2)

LDART

EXPERIMENTAL

Participants will be given access to LDART for 28 days.

Device: LDART

Psychoeducational booklet

ACTIVE COMPARATOR

Participants will be sent a PDF of this booklet.

Behavioral: Psychoeducational booklet

Interventions

This is a 10-page PDF on stimulant use disorder created by the American Society of Addiction Medicine and American Academy of Addiction Psychiatry. It contains information about stimulant intoxication and withdrawal and treatment options. Participants will be encouraged to access this booklet for a few minutes each night over the 4-week intervention period.

Psychoeducational booklet
LDARTDEVICE

Let's Do Addiction Recovery Together! (LDART) is a web-based intervention grounded in social cognitive theory that is designed to reduce hazardous alcohol use. It has three active ingredients: 1) daily recovery goal setting and tracking, 2) motivational video, audio, and written messages from individuals in recovery, and 3) information on several community-based recovery groups (e.g., mutual-help groups, recovery community centers) that provide free, publicly available meetings and activities. Participants receive a text message reminder each night to go to the website to complete the activities, and a text message reminder each morning of the goal they set for themselves, with the option to change it. It only takes a few minutes to use LDART each day over the 4-week intervention period.

LDART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Currently reside in Connecticut, USA
  • Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month
  • Substance (Stimulant) Use Symptom Checklist ≥2, indicating past-year stimulant use disorder
  • Had high frequency of cocaine use (≥5 days) in the past 28 days
  • Have some self-reported desire to cut down or quit stimulants

You may not qualify if:

  • Unable to provide informed consent, as assessed by the consent quiz
  • Unable to speak, read, or write in English
  • Vulnerable population status
  • Unlikely to be able to complete study procedures in the next 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Study Officials

  • Li Yan McCurdy, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2025

First Posted

October 27, 2025

Study Start

April 29, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations