14 August 2012

Pilot RCT points to reduced retention, increase abstinence from illicits and alcohol with more supervision.

A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment. Holland R, Matheson C, Anthony G, Roberts K, Priyardarshi S, Macrae A, Whitelaw E, Appavoo S, Bond C. D&A Rev 2012 6:483-91

Dear Colleagues,

My old professor held that it was nice to learn of controlled research supporting one’s long-held clinical beliefs. This pilot study by a Scottish group fit’s the bill in my book.

There were 60 stable methadone maintenance patients randomised to daily supervised doses (existing treatment), twice weekly supervised doses and daily unsupervised (dispensed) dosing in community pharmacies with surveys and urine tests over a three month study period. The unsupervised patients were still required to collect their medication bottles at the pharmacy daily (this seems to be a uniquely British practice).

The authors state: “This small study was not statistically powered to estimate the effectiveness of different forms of supervision. Nevertheless, our findings are of interest as results suggest that increasing levels of supervision decreased retention (a negative finding), while reducing illicit heroin and alcohol use (a positive finding). This was not statistically significant (with the exception of the alcohol result) and should be treated with caution.” [alcohol problems were reduced from 47 to 33%, a significant reduction, only in the supervised group - other groups showed the same or worse figures].

In their introduction the authors state: “..there is no evidence base for deciding the optimal period of supervision”. In fact there is some controlled research for observed dosing (ref 1) but in opiate treatment the common practice has been of early supervision and the use of take-away doses later in treatment (as also followed by this service in Scotland). This regimen is used in a large proportion of research reports, virtually all with successful outcomes compared with controls - and with few adverse reports. This is the research basis for all opioid maintenance treatments used around the world today. It also parallels what we do with unstable mental patients or diabetics who are commencing treatment. They are usually given supervised treatment for days, weeks or sometimes months rather than bottles of pills, syringes or other therapies to take home for self administration. This is just sound therapeutics utilising available resources.

Controlled research over days, weeks and a few short months has also been done on dose supervision for patients with malaria, HIV, tuberculosis, HCV and renal tract infections with demonstrated benefits, sometimes dramatic ones. The uncharted territory is in long-term treatment since most formal research is of limited duration. Hence the crucial importance of this type of study in longer-term patients. With the authors’ positive and negative findings above, they appear to be supporting the need for initial supervision with early introduction of take-away doses in appropriate cases.

A substantial black market price for any drug and/or a shortage of the treatment availability (such as HIV meds in the third world or America) can yield a strong incentive to sell or divert medication. New patients and those in difficulties may benefit from on-going observation of their dosing (called ‘DOT’ in some work: Directly Observed Therapy) regardless of what they are being treated for.

In the UK uniquely, addicted patients who are new to treatment are often given doses to consume at home despite no controlled research base for this. Indeed, in some countries this would be considered unethical and dangerous, like the criticism of ‘giving alcohol to alcoholics’ (also debateable - see below Toronto experience ref 3).

New York Mayor Giuliani and Senator John McCain have joined a small number of high profile people with serious attempts to restrict the US methadone program, (which is largely *supervised*). Methadone treatment was called “disgusting and immoral” and “an Orwellian drug swap.” It would be even easier to criticise the UK program which is largely unsupervised. While there are calls for methadone maintenance to be curtailed (Ref 2) there are still UK experts trying to defend the use of unsupervised methadone treatments despite its unproven nature. Such moves to restrict opiate programs have naturally caused disquiet amongst this most vulnerable and stigmatised group.

Supervision using adequate methadone doses and graduated take-home provisions for suitable patients - an approach which is evidence-based and time honoured. And in the UK, even those on official government funded treatment, many receive treatment which is sub-optimal and ineffective (Ref 4). As well as ensuring compliance and protecting the patient/family, dose supervision also protects this treatment from needless controversy. In an exhaustive email exchange with one of the most respected addiction writers in England recently the only concession on this matter I received was: “Andrew, on one thing at least we agree - that supervision may be needed to allay public and political concern. Another is of course that done well it eliminates diversion. And these two facts are of course related.”

I say no more.

Comments by Andrew Byrne ..

Citation: Holland R, Matheson C, Anthony G, Roberts K, Priyardarshi S, Macrae A, Whitelaw E, Appavoo S, Bond C. A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment. D&A Rev 2012 6:483-91

Ref 1. Rhoades HM, Creson D, Elk R, Schmitz J, Grabowski J. Retention, HIV Risk, and Illicit Drug Use uring Treatment: Methadone Dose and Visit Frequency. 1998 Am J Public Health 88:34-39

Ref 2. Methadone to be dumped in Scotland as treatment for heroin addiction. http://www.news-medical.net/news/2008/05/27/38661.aspx

Ref 3. Podymow T, Turnbull J, Coyle D, Yetisir E, Wells G. Shelter-based managed alcohol administration to chronically homeless people addicted to alcohol. CMAJ 2006 174;1:45-49

Ref 4. The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales. Strang J, Sheridan J, Hunt C, Kerr B, Gerada C, Pringle M. Brit J General Practice (2005) 55 (June 2005); 515: 444-451

Disclosure: Dr Byrne owns a clinic which, like addiction clinics in most countries supervises methadone, buprenorphine, diazepam, antabuse and other medications for a fee.