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Background: Some countries have used opioid agonist medications other than methadone and buprenorphine as a strategy to increase treatment diversity. In Iran and other countries where opium use is common and culturally tolerated, opium tincture (OT) has gained growing popularity and been approved to treat opioid use disorder (OUD). Given the increasing interest in this intervention, we conducted a systematic review of the literature to evaluate the safety and efficacy of OT-assisted treatment for OUD.Methods: We systematically searched international (MEDLINE, Embase, CINAHL, PsychInfo, Google Scholar, and clinicaltrials.gov) and Iranian (Scientific Information Database (SID), Iranmedex, IranDoc, digital library of Iran's Drug Control Headquarters and the Iranian Registry for Clinical Trials) databases on November 04, 2020 without any language or publication date limitations. Two reviewers screened the titles, abstracts, and full-text of the retrieved records to find clinical trials or observational studies that assessed the safety and efficacy of OT-assisted treatment for OUD.Results: We screened 1301 records and included 21 unique studies on assisted withdrawal (n = 5), maintenance (n = 9), and gradual dose reduction (n = 7) treatment regimens. Most studies included men and people with opium use disorder. We found only six randomized controlled trials (RCT). Our results showed that OT-assisted treatment is associated with comparable outcomes with methadone treatment in both assisted withdrawal and maintenance treatment regimens. We also found promising results for using gradual dose reduction regimen of OT-assisted treatment from observational studies. The overall quality of scientific evidence was low due to the limited number RCT and high risk of bias in the included studies.Conclusions: The body of evidence supporting the safety and efficacy of OT-assisted treatment in assisted withdrawal, maintenance, and gradual dose reduction regimens is limited but somewhat promising, in particular among people with opium use disorder. Our review calls for higher-quality studies to investigate the comparative efficacy of these treatment methods with standard pharmacotherapies for OUD. [ABSTRACT FROM AUTHOR]