Opium tincture-assisted treatment for opioid use disorder: A systematic review

Noroozi, Alireza; Kebriaeezadeh, Abbas; Mirrahimi, Bahareh; Armoon, Bahram; Ahounbar, Elaheh; Narenjiha, Hooman; Salehi, Mohammad Amin; Karamouzian, Mohammad

doi:10.1016/j.jsat.2021.108519

Cited by 3 publications

(5 citation statements)

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“…However, AEs with OT have remained largely unreported in previous studies [30]. It was reassuring that no serious AE was observed with OT in this study or in previous studies [9]. Nevertheless, the data indicate that there is a need for close monitoring of AEs clinically and documentation of AEs with the use of OT for OAT in future studies.…”

Section: Discussionsupporting

confidence: 64%

“…Another study by Mokri et al . in 2010 [9] reported a mean length of retention in treatment equal to 2.9 (2.1) months and highlighted the positive impact of a higher initial dose on treatment retention. These findings may suggest that a higher initial and maintenance dose of OT might have improved treatment retention in the present trial.…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, a systematic review on OT for OAT conducted by our research group in 2016 indicated a lack of adequate published evidence supporting its effectiveness and safety for this indication [6]. A more recent update of the review (2021) that included two randomized controlled trials (RCTs), two retrospective cohort studies and five prospective cohort studies arrived at a similar conclusion, finding that the evidence supporting the effectiveness and safety of OT maintenance for opioid use disorder is overall limited, but promising [9]. To address this knowledge gap, a randomized clinical trial was conducted comparing outcomes for groups receiving OAT with OT versus methadone using methadone as the comparison, as it is the most widely used medication for OAT across the globe.…”

Section: Introductionmentioning

confidence: 98%

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Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial

et al. 2022

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Aim To test if opium tincture (OT) was non‐inferior to methadone in retaining participants in opioid agonist treatment (OAT). Design A Phase III, multi‐centre, parallel‐group, non‐inferiority, double‐blind randomized controlled trial with an allocation ratio of 1:1. Participants were provided treatment and followed for a period of 85 days. Setting Four OAT clinics in Iran. Participants Two hundred and four participants with opioid use disorder [mean age (standard deviation) = 37.4 (9.3); female 11.3%] recruited between July 2017 and January 2018. Interventions Participants were assigned to either OT (102) or methadone (102) using a patient‐centred flexible dosing strategy. Measurements Treatment retention over 85 days was the primary outcome. Self‐reported opioid use outside treatment and occurrence of adverse events (AEs) were the secondary outcomes. Findings Remaining in treatment at the end of the follow‐up were 68.6% in the methadone arm and 59.8% in the OT arm. The relative retention rate of methadone to OT was 1.15 (0.97, 1.36) in both intent‐to‐treat and per‐protocol analyses; non‐inferiority was not supported statistically, as the upper bound of the confidence interval exceeded our pre‐specified non‐inferiority margin (1.25). Opioid use outside treatment was reported by 30.3% of OT (n = 152) and 49.4% of methadone (n = 168) patients, a difference in proportions of −19%: 90% confidence interval (−28%, −10%). The total count of AEs in the OT arm (22 among nine individuals) was significantly higher (P = 0.04) than that in the methadone arm (three among two individuals). Nausea was the most common side effect. Conclusion While this study could not conclude the non‐inferiority of opium tincture (OT) to methadone for retaining patients in opioid agonist treatment, OT retained 60% of participants to end of follow‐up (85 days) and was superior to methadone in reducing self‐reported opioid use outside treatment.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

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Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial

et al. 2022

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“…Data on the effectiveness of OT for the treatment of OUD come mainly from observational studies, and although several studies conducted in Iran recruited people with opium, concentrated opium (i.e. Shireh) or heroin as their main opioid of choice, they did not provide subgroup analyses to reveal potential differences in outcomes among people who use opium or heroin [4].…”

mentioning

confidence: 99%

“…Access to opioid agonist treatments (OATs) with methadone or buprenorphine is the cornerstone of national responses to OUD epidemics in many countries [2]; however, not all patients with OUD respond to these treatments [3]. OT is proposed as an alternative treatment for people with OUD in general, and OUD in particular, in South East and South West Asia [4], where opium is the dominant drug of choice in several countries [5]. Data on the effectiveness of OT for the treatment of OUD come mainly from observational studies, and although several studies conducted in Iran recruited people with opium, concentrated opium (i.e.…”

mentioning

confidence: 99%