Substance Use Disorders Clinical Trial
Official title:
RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older - Enrolled in an outpatient SUD treatment program - Enrolled in treatment for < 90 days - Fluent in English - Have access to a smartphone with iOS or Android Capabilities - Capable of providing informed consent Exclusion Criteria: - Pregnancy - Prisoner Status - Significant limitation of range of motion of non-dominant arm (amputation or fracture) |
Country | Name | City | State |
---|---|---|---|
United States | University of Massachusetts Chan Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
ContinueYou, LLC | University of Massachusetts, Worcester, University of Texas at Tyler |
United States,
Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3. — View Citation
Carreiro S, Taylor M, Shrestha S, Reinhardt M, Gilbertson N, Indic P. Realize, Analyze, Engage (RAE): A Digital Tool to Support Recovery from Substance Use Disorder. J Psychiatr Brain Sci. 2021;6:e210002. doi: 10.20900/jpbs.20210002. Epub 2021 Feb 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with return to drug use | Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment) | 3 months | |
Secondary | Number of participants retained in treatment | Participants status as engaged in recovery treatment (index treatment program or other) | 3 months | |
Secondary | Number of hospitalizations and emergency department visits per participant | Includes absolute number of Emergency Department visits (SUD and non-SUD related), number of unplanned hospital admissions (SUD and non-SUD related), number of days hospitalized (SUD and non-SUD related admissions) and overdose related visits | 3 months |
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