Single-arm Study of LDART for Stimulant Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Stimulant Use Disorder; Cocaine Use Disorder; Methamphetamine Use Disorder

• Registration Number: NCT07221396
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Study Start: 2025-11-15
• Primary Completion: 2026-11-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recruitment rate	From enrollment to the final assessment time point (Day 56)	The percentage of eligible participants who are enrolled relative to the total number of eligible potential participants who completed the screening.
Accrual rate	From enrollment to the final assessment time point (Day 56)	The rate of enrollment, defined as number of participants enrolled per month.
Retention rate	From enrollment to the final assessment time point (Day 56)	The percentage of enrolled participants who complete all study-related procedures (i.e., all three assessments).
Intervention engagement	From beginning the intervention (Day 1) to the end of the intervention period (Day 28)	Number of nights enrolled participants completed the activities on the LDART website, out of 28 nights.
Intervention acceptability	The second assessment time point (post-intervention, Day 28)	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in stimulant use frequency	Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)	Change in self-reported number of days when any stimulants were used in the past 28 days, as measured using the Timeline Follow-back.
Change from baseline in number of recovery groups engaged with	Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)	Self-reported number of recovery groups engaged with in the past 28 days

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States