LDART for Stimulant Use Disorder

(LDART Trial)

Overseen By Li Yan McCurdy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Unable to consent, English, vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called LDART to determine if it helps individuals with stimulant use disorder feel more positive about reducing or quitting. The trial aims to assess the ease and effectiveness of LDART for those who have frequently used cocaine in the past month and wish to reduce or stop using stimulants. Ideal participants live in Connecticut, have recently used stimulants like cocaine, and want to change this habit. Participants must have a smartphone with internet access and be able to communicate in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could benefit others in the future.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this digital intervention is safe for adults with stimulant use disorder?

Research has shown that digital tools like LDART are generally safe because they don't involve medication or physical treatments. Although specific data on LDART's safety is not available, its digital nature avoids the risks associated with drug therapies, suggesting it is likely well-tolerated by most people.

LDART is not a drug or stimulant, so it lacks the side effects those treatments might have. Instead, LDART aims to help manage stimulant use disorder through digital methods, such as an app or online program. Since this trial doesn't involve a new drug, concerns about the side effects often associated with medications are reduced. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for stimulant use disorder, such as behavioral therapy and medications like bupropion or naltrexone, LDART offers a unique approach. LDART stands out because it utilizes a digital platform to deliver therapy, making it accessible anytime and anywhere. This method could significantly enhance engagement and adherence to treatment, offering users continuous support and potentially leading to better outcomes. Researchers are excited about LDART because it represents a shift towards integrating technology in addiction treatment, providing a more adaptable and user-friendly option.

What evidence suggests that LDART is effective for stimulant use disorder?

Research has shown that digital tools can help reduce stimulant use. Although specific data on LDART is limited, studies suggest that less frequent stimulant use indicates treatment success. Similar digital tools have helped individuals remain engaged in treatment and reduce substance use. By offering accessible and organized support, tools like LDART, available to participants in this trial for 28 days, may assist in managing cravings and developing healthier habits. This method aims to provide a flexible and supportive approach to addressing stimulant use disorder. ^{5 6 7 8 9}

Who Is on the Research Team?

Li Yan McCurdy, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults in Connecticut with stimulant use disorder who've used cocaine frequently. Participants need a smartphone with text and internet access, want to reduce or quit stimulant use, and must be over 18. Excluded are those not fluent in English, vulnerable individuals, anyone unable to complete the study soon, or unable to consent.

Inclusion Criteria

Currently reside in Connecticut, USA

Have a smartphone that can send and receive text messages and have internet access that can be accessed over the course of a month

Substance (Stimulant) Use Symptom Checklist ≥2, indicating past-year stimulant use disorder

Exclusion Criteria

Unable to speak, read, or write in English

Vulnerable population status

Unlikely to be able to complete study procedures in the next 2-3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are given access to the LDART digital intervention for 28 days

4 weeks

Virtual engagement with the LDART platform

Follow-up

Participants are monitored for changes in stimulant use and engagement with recovery groups

4 weeks

1-month post-intervention assessment

What Are the Treatments Tested in This Trial?

Interventions

• LDART

Trial Overview The study tests LDART, a digital intervention designed for adults struggling with stimulant addiction. It aims to assess how well participants accept this technology-based treatment and its initial effectiveness in helping them manage their addiction.

How Is the Trial Designed?

Group I: LDART Experimental Treatment 1 Intervention

Participants will be given access to LDART for 28 days.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

College on Problems of Drug Dependence

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6688478/

Stimulant Medication and Substance Use Outcomes Two studies found that stimulant medication treatment reduced risk of alcohol abuse or dependence, whereas 1 study found that children treated with stimulant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434364/

ADHD, substance use disorders and stimulant treatment The most recent meta‐analysis found no increased or decreased risk . Longitudinal data from the Multimodal Treatment Study of ADHD also did not ...

3. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/adult-adhd.pdf

ADHD and Substance Use Disorders in Adults There are limited data about misuse and diversion of stimulant medications ... Stimulant medication and substance use outcomes: A meta-analysis. JAMA.

4. legislativeanalysis.org legislativeanalysis.org/wp-content/uploads/2024/01/Reduced-Drug-Use-as-an-Alternative-Valid-Outcome-in-Individuals-With-Stimulant-Use.pdf

Reduced drug use as an alternative valid outcome in ... This study examined the validity of reduced frequency of stimulant use as a treatment outcome for stimulant use disorders by exploring the association ...

5. library.samhsa.gov library.samhsa.gov/sites/default/files/pep20-06-01-001.pdf

Treatment of Stimulant Use Disorders This guide discusses effective practices to treat stimulant use disorders, clinical challenges associated with these disorders, and implementation strategies ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065045/

Safety of Stimulants Across Patient Populations Prolonged exposure to stimulants lasting 5 to 14 years may increase the risk of cardiovascular disease. In response to these concerns, several ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions

FDA updating warnings to improve safe use of prescription ... According to the available data, people who use prescription stimulants for nonmedical reasons have a higher risk of developing a substance use ...

8. uspharmacist.com uspharmacist.com/article/stimulant-use-safety-when-used-beyond-adhd-treatment

Stimulant Use Safety When Used Beyond ADHD Treatment “This meta-analysis found an increased risk of overall AEs associated with stimulants compared with placebo,” according to the researchers. “ ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40343695/

Safety of Stimulants Across Patient Populations: A Meta-Analysis This meta-analysis found an increased risk of overall AEs associated with stimulants compared with placebo. Future research could provide ...