{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T12:33:59Z","timestamp":1793450039549,"version":"4.5.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000026","name":"National Institute on Drug Abuse","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Pear Therapeutics, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Substance Abuse"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:p>Background: Traditional treatments for substance use disorders (SUDs) rely heavily on face-to-face interactions, which pose substantial limitations for patients. A clinical trial of a digital therapeutic (DT), delivering behavioral therapy demonstrated safety and efficacy in a population including patients with opioid use disorder (OUD) not treated with buprenorphine, which is not a guideline-recommended approach. This study re-analyzed the data excluding patients with OUD to more closely approximate real-world patient populations. Methods: Secondary analysis of patients with substance use disorders related to alcohol, cannabis, cocaine, or other stimulants ( n\u2009=\u2009399, patients with OUD excluded) from a previously-published randomized controlled trial. Patients received 12-weeks of outpatient treatment-as-usual (TAU; n\u2009=\u2009193) or TAU with reduced counseling plus a DT ( n\u2009=\u2009206) providing computerized cognitive behavioral therapy and contingency management. Primary outcomes were abstinence in weeks 9\u201312 and retention in treatment. Results: The 399 patients in this analysis (206 in the DT group and 193 in the TAU group) reported substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (e.g., methamphetamines). Demographic and baseline characteristics including age, sex, race, education, and reported primary substance use disorder were balanced between treatment groups. Abstinence was significantly higher in the DT group compared to TAU (40.3 vs. 17.6%; p\u2009&lt;\u20090.001) as was retention in therapy (76.2 vs. 63.2%, p\u2009=\u20090.004). Intergroup adverse event rates were not significantly different ( p\u2009=\u20090.68). Conclusions: The results demonstrate that use of a DT safely increased abstinence (reduced substance use) and retention in treatment among patients with substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (including methamphetamines).<\/jats:p>","DOI":"10.1080\/08897077.2022.2060425","type":"journal-article","created":{"date-parts":[[2022,4,14]],"date-time":"2022-04-14T14:33:58Z","timestamp":1649946838000},"page":"937-942","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":23,"title":["Safety and Efficacy of a Digital Therapeutic for Substance use Disorder: Secondary Analysis of Data from a NIDA Clinical Trials Network Study"],"prefix":"10.1177","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8667-5233","authenticated-orcid":false,"given":"Yuri A.","family":"Maricich","sequence":"first","affiliation":[{"name":"Pear Therapeutics, Inc., Boston, Massachussetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2055-3425","authenticated-orcid":false,"given":"Edward V.","family":"Nunes","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, New York State Psychiatric Institute, Columbia University Medical Center, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4247-9980","authenticated-orcid":false,"given":"Aimee N. C.","family":"Campbell","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, New York State Psychiatric Institute, Columbia University Medical Center, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey D.","family":"Botbyl","sequence":"additional","affiliation":[{"name":"Provonix LLC, Sewell, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3737-946X","authenticated-orcid":false,"given":"Hilary F.","family":"Luderer","sequence":"additional","affiliation":[{"name":"Pear Therapeutics, Inc., Boston, Massachussetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,1,1]]},"reference":[{"key":"bibr1-08897077.2022.2060425","unstructured":"National Academies of Sciences Engineering and Medicine. Medications for Opioid Use Disorder Save Lives. Washington, DC: The National Academies Press 2019."},{"key":"bibr2-08897077.2022.2060425","unstructured":"Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). https:\/\/www.samhsa.gov\/data\/. Accessed October 28, 2021."},{"key":"bibr3-08897077.2022.2060425","volume-title":"The ASAM Principles of Addiction Medicine","author":"Miller SC","year":"2018","edition":"6"},{"key":"bibr4-08897077.2022.2060425","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsat.2010.11.002"},{"key":"bibr5-08897077.2022.2060425","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10101443"},{"key":"bibr6-08897077.2022.2060425","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsat.2013.08.010"},{"key":"bibr7-08897077.2022.2060425","unstructured":"Institute of Medicine. Improving the Quality of Health Care for Mental and Substance-Use Conditions. Washington, DC: The National Academies Press; 2006."},{"key":"bibr8-08897077.2022.2060425","doi-asserted-by":"publisher","DOI":"10.1111\/add.14793"},{"key":"bibr9-08897077.2022.2060425","unstructured":"Food & Drug Administration. FDA permits marketing of mobile medical application for substance use disorder. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-permits-marketing-mobile-medical-application-substance-use-disorder. Accessed January 26, 2021."},{"key":"bibr10-08897077.2022.2060425","unstructured":"Center for Devices and Radiological Health. De Novo Summary for reSET (DEN160018). 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