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Digital Therapeutic
Digital Therapeutic + Counseling for Substance Use Disorders
Phase 2
Recruiting
Research Sponsored by Square2 Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial will test an app to help people with substance use disorders and their support people. It will compare the app's effectiveness to standard treatment to see if it helps people stay in recovery.
Who is the study for?
This trial is for adults over 18 with substance use disorders who are starting outpatient treatment. Participants must be able to consent, commit to the study's full duration, have a support person join them in the study, and own a functioning smartphone. It excludes those who can't understand or read English.Check my eligibility
What is being tested?
The study tests Laddr®, an app designed to help people stop using substances by providing information and skills on their smartphones. The new social feature of Laddr® lets users involve a support person in their recovery process. Its effectiveness will be compared with standard outpatient treatments alone.See study design
What are the potential side effects?
Since this intervention involves digital therapy through an app rather than medication, traditional side effects are not applicable. However, participants may experience stress or emotional discomfort while engaging with the content related to substance cessation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention in treatment Retention in treatment Retention in treatment Retention in treatment Retention in treatment
Secondary outcome measures
Assessment of Recovery Capital (ARC)
Coping Strategies Scale (CSS)
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard outpatient treatment plus Laddr®Experimental Treatment1 Intervention
Laddr® is a smartphone application integrating science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes tools for activating behavior change, solving problems and overcoming obstacles to effective behavior change; teaching skills and providing guidance on the execution of behavior change; and maintaining the end user's motivation to change. It enables longitudinal assessment of individuals' behavior and health status in naturalistic contexts, offers science-based self-regulation behavior change tools of relevance to an array of populations, and enables ongoing monitoring of health behavior. This study evaluates the effectiveness of new features to Laddr®. These new features are designed to be used with a support person, which could include a friend, family member, or acquaintance.
In addition to Laddr®, participants will receive standard outpatient substance use disorder treatment.
Group II: Standard outpatient treatmentActive Control1 Intervention
The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,404 Total Patients Enrolled
Square2 Systems, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You own a working smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Standard outpatient treatment plus Laddr®
- Group 2: Standard outpatient treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with the Standard outpatient treatment in combination with Laddr®?
"Our risk assessment assigned Standard outpatient treatment plus Laddr® a score of 2, as this is only a Phase 2 trial and there is limited data regarding its efficacy."
Answered by AI
What is the current enrollment figure for this trial?
"Affirmative. According to information hosted on the clinicaltrials.gov website, this medical trial was first posted on November 9th 2022 and is currently recruiting participants across 1 site with a target amount of 189 patients."
Answered by AI
Are there currently any slots open to join this scientific study?
"Affirmative. Data hosted on the clinicaltrials.gov website reveals that enrolment is open for this medical study, which was first posted on November 9th 2022 and most recently updated December 5th 2022. The recruitment process requires 189 patients from a single site to participate in the trial."
Answered by AI
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