Opioid use carries significant risks and the resolution of opioid use disorders is challenging [1, 2]. Opioids (including heroin) are responsible for four out of five drug related deaths globally [3]. Injecting drug use significantly increases the chances of developing infections and suffering a variety of health issues, including contracting HIV and hepatitis C (HCV) [4]. Stigma, social exclusion, a lack of accessible services (including healthcare) and criminalisation add to the challenges confronting opioid dependent people [5]. Dependent opioid users experience unpleasant and painful symptoms of physical withdrawal unless they take regular doses (three-six hourly) [6]. Some people who use opioids find temporary relief from the physical and emotional pain they may be experiencing [7–10]. Stopping opioids is often an unrealistic or undesirable outcome for many people who use them. The World Health Organization (WHO) recommends opioid agonist treatment for the treatment of opioid use disorders due to its effectiveness [11].

Methadone and buprenorphine are opioid agonist medications that act on the same receptors in the brain as opioids and relieve symptoms of withdrawal [11]. Opioid agonist treatment involves a trained clinician prescribing agonist medications at appropriate doses. At appropriate doses, this therapy reduces opioid use [11, 12] and the risk of HIV and HCV infection among people who inject drugs, increases adherence to antiretroviral therapy [13] and reduces mortality by up to 75% [14]. Opioid agonist treatment dramatically reduces the medical and societal costs related to opioid use [15, 16]. For every dollar invested in opioid agonist treatment, $5–$12 are saved on potential costs related to opioid use disorders where agonist medications are not prescribed. Additional savings occur when crime and criminal justice costs are considered [13]. Methadone maintenance therapy refers to opioid agonist treatment that is limited to the use of methadone for maintenance.

Community based, low threshold approaches to methadone maintenance improve retention [17]. These enable easy access (including mechanisms to link people with opioid use disorders to treatment), operate with limited resources, and are accessible to participants with limited financial resources and in contexts where drug use is criminalised [17]. Retention is enhanced by offering patient-centred dosing (without ceiling doses), minimising barriers to entry, and adopting approaches that do not demand total abstinence from opioid or other drugs [17–19]. In contrast, high threshold approaches have strict entry requirements, are abstinence-centric, require frequent urinalysis, have rigid dosing, and mandate psychosocial support [17]. Low threshold programmes are therefore a more realistic option for many opioid users [20, 21].

Opioid use is increasing in South Africa with few institutions or mechanisms to prevent what could become a public health crisis [22]. Seizures of heroin in East Africa have risen 100 fold over the past decade, indicating a significant increase in trafficking. Much of the trafficked heroin is bound for South Africa [23]. There is, however, no reliable empirical data on the prevalence of heroin use in the country. The United Nations Office on Drugs and Crime estimates that 0.5% of the population aged 15–64 in South Africa has used opioids in the past year [24], translating to around 184,030 people [25]. Most heroin is smoked or inhaled, either alone or in combination with other substances (e.g. tobacco or cannabis) [26]. The cost of a gram of heroin in South Africa fell threefold from 2004 to 2014 [27]. To date, the country has relied almost exclusively on abstinence based residential treatment or out-patient services with very low ‘success’ rates, usually measured in terms of abstinence [28, 29].

The World Health Organization’s comprehensive package of HIV and viral hepatitis prevention, testing, treatment and care interventions have neither been funded nor implemented by the South African government [30, 31]. South Africa’s first needle and syringe programme started in 2014 in Cape Town, extending to Durban and Pretoria in 2015. In May 2018 the Durban municipality stopped the needle and syringe programme for their cited concerns of insufficient stakeholder consultation and management of used injecting equipment [32], which by January 2020 was still on hold.

Between January and June 2018, 4% of the 7316 people who inject opioids who accessed harm reduction programmes were started on opioid agonist treatment1 [33]. Methadone and buprenorphine (± naloxone) are registered for use and only methadone is listed on the essential medicine list for use at hospital level for detoxification (i.e. neither medication is available in the public sector for maintenance) [31, 34]. Agonist medications are prescribed by medical practitioners in the private sector, civil society organisations and universities. Between 2015–2017 South Africa’s consumption of narcotic drugs and buprenorphine was ranked 74th globally (521 defined daily doses per million inhabitants per day; 35 for methadone and 15 for buprenorphine) [35]. The first opioid agonist treatment clinic started in 2011 at Stikland Hospital (Cape Town), with patients self-funding their medications, with a similar clinic starting at Groote Schuur Hospital (Cape Town) 2 years later. The first community-based opioid agonist treatment programme was started in 2014 by a civil society organisation with local government funding. The project provided buprenorphine-naloxone for 3 months to non-injecting opioid users using a high threshold approach with 66% (44/67) completing the project [29]. The limited access to opioid agonist treatment has been partly due to concerns around limited acceptance of the intervention by key stakeholders [31], safety concerns [36], and the impact on the health system and prohibitive costs [28]. Naltrexone in tablet form is registered and only available for use in the private sector. Naloxone is listed on South Africa’s essential medicine list for the management of opioid poisoning across all levels of care [37]. To date, no naloxone distribution programmes have taken place [38].

In response to these issues, the alignment of low-threshold approaches with harm reduction principles [17] and our experience, as well as a donation of methadone, we implemented South Africa’s first low threshold methadone maintenance therapy project. At the time of project planning implementing the project within a government primary care health facility was not possible. Here we present participant baseline social, demographic and drug use data, as well as retention and changes in quality of life and substance use after 6 months on the study. Qualitative research findings around participant experiences will be presented in a separate paper.