Pear Therapeutics Presents Real-World Clinical Data Assessing Engagement and Abstinence in Patients with Alcohol Use Disorders Using reSET® at AAAP
December 15, 2022
- Alcohol is the most common substance use disorder (SUD), representing 70% of the more than 40 million people with SUD1
- New data from real-world use of reSET® demonstrate patients who use alcohol exhibit robust engagement, retention, and abstinence
“Alcohol use disorder (AUD) currently affects about 28 million people in
The real-world observational study evaluated 548 patients with alcohol-related disorders from 28 states who were treated with reSET over 12 weeks. The primary endpoint was engagement with reSET (lessons completed) throughout the prescription, and activity was also assessed as any use of reSET during a given week. The secondary endpoint was abstinence as measured by a composite of self-report and urine drug screens.
Highlights presented include:2
- 69.7% of patients (n=548) were retained in treatment during weeks 9-12 (last 4 weeks)
- 59% of patients (n=548) were abstinent (during weeks 9-12): no substance use as measured by a composite of self-report and drug testing
These data highlight benefits from reSET, which is indicated to treat addiction to cannabis, cocaine, and stimulants and alcohol when used with another substance.
For more information, please view the poster abstract here.
Pear, which received Breakthrough Device Designation from FDA for an AUD-only indication for reSET, has not yet received marketing authorization for an AUD-only indication.
reSET Important Safety Information
Indications for Use:
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.
It is intended to:
- Increase abstinence from a patient’s substances of abuse during treatment, and
- Increase retention in the outpatient treatment program.
Important Safety Information:
Warnings: reSET is intended for patients whose primary language is English or Spanish with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
Patients with substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.
This Press Release does not include all the information needed to use reSET safely and effectively. Please see the Clinician Brief Summary for reSET for more information.
SAMHSA. Key substance use and mental health indicators in
the United States: Results from the 2020 Survey on Drug Use and Health. https://www.samhsa.gov/data/. Published 2020. Accessed December 8, 2022.
- Luderer H, Sullivan MA, Xiong X, Maricich Y. A prescription digital therapeutic for substance use disorder: real-world engagement and abstinence patterns in patients diagnosed with alcohol-related disorders. Poster 71. https://aaap.societyconference.com/conf/#sessions/conf10004.
Centers for Disease Control & Prevention. Alcohol and Public Health: Alcohol-Related Disease impact. Retrieved from https://nccd.cdc.gov/DPH_ARDI/Default/Report.aspx?T=AAM&P=612EF325-9B55-442B-AE0C-789B06E3A8D5&R=C877B524-834A-47D5-964D-158FE519C894&M=DB4DAAC0-C9B3-4F92-91A5-A5781DA85B68&F=&D= Accessed December 8, 2022.
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Senior Director, Corporate Communications