Clinical & Policy Updates:
SMMGP Clinical Update #42 - October 2014
Compiled by Dr Euan Lawson
|Download the PDF version of this Update here! (PDF*, 192K)|
Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: A randomized clinical trial
Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, et al. JAMA Psychiatry 2014, May;71(5):547-56
This study recognises the importance of addressing relapse in managing substance misuse disorders. They randomised patients to either a programme of mindfulness-based relapse prevention (MBRP), relapse prevention (RP), or to treatment as usual (TAU) which involved a 12-step programme and psychoeducation. The primary outcomes were: relapse to drug use and heavy drinking. They assessed participants at the 3-, 6- and 12-month points. They also included self-reported relapse and urinalysis.
There were no differences between the groups at the 3-month assessment point. At 6 months the results showed that patients in the MBRP and RP groups reported significantly lower risk of relapse to substance misuse and heavy drinking. Those who used substances had significantly fewer days of substance misuse and heavy drinking. At the 12-month follow up MBRP reported significantly fewer drug use days and a lower risk of heavy drinking than RP participants.
Commentary: This is a novel intervention but there is no doubt about the growing interest in mindfulness as an approach. There is a risk that the initial perception is that it is some pseudo-mystical belief system but it is certainly not about sitting around cross-legged, chanting to one's self. There is good evidence around its use in other conditions and NICE recommend mindfulness-based cognitive therapy as an evidence-based intervention in certain types of depression. (I'll mention, in passing, that there is also evidence around its use to help doctors with burnout.) This is the first paper I've seen for its specific use in substance misuse situations - and publication in JAMA Psychiatry emphasises the mainstream credibility of mindfulness.
The treatment-as-usual control group in this study was described as "abstinence based, primarily process oriented, and based on the Alcoholics/Narcotics Anonymous 12-step program". I'm not sure, in the UK, we would necessarily describe the 12-step programme as usual care and that could be significant in considering this study. It all rather depends on the contents of the relapse prevention programme - in this case, it included 8 weekly group sessions of cognitive-behavioural RP which were matched with the MBRP in time, format, size and location. Objectives in the RP programme included assessment of high-risk situations, coping skills and problem solving. The MBRP had 8 weekly 2-hour sessions with groups of 6 to 10 participants. They explored and developed themes in areas such as: the role of the "automatic pilot" in addiction, mindfulness in high-risk situations, and sessions included 20-30 mins of guided meditation.
As an aside, this study isn't very good news for those who do advocate a 12-step approach - given the RP and MBRP groups did considerably better. The RP intervention was good but the MBRP started to outdistance it at one year of follow-up suggesting that there may be an enduring additional effect on relapse prevention from mindfulness techniques. However, as is common, the studies don't report beyond that so any suggestion of the long-term influences of mindfulness remains speculative.
Hospital readmissions with exacerbation of obstructive pulmonary disease in illicit drug smokers
Yadavilli R, Collins A, Ding WY, Garner N, Williams J, Burhan H. Lung 2014, Aug 6
This paper reports on a study that looked at sequential acute admissions to the Royal Liverpool University Hospital. They identified anyone who was managed as "exacerbation of COPD" from January 2009 to September 2011. The diagnosis was a clinical one - this was a retrospective review of the notes and not everyone had spirometry to confirm the diagnosis. They split the admissions into three groups: current/ex-illicit drug users; ex-tobacco smokers; and current tobacco smokers.
After excluding those with incomplete data they were left with 709 patients with 950 admissions. These divided into 620 patients that had smoked tobacco (772 admissions) and 89 patients who smoked illicit drugs (178 admissions). The illicit drug smokers were younger (average age of 50), compared with current tobacco smokers (average age of 70). They had shorter hospital stays of around 7.4 days - with the other two groups staying 2-3 days longer. They were more likely to be re-admitted and they also suffered more type 2 respiratory failure which required non-invasive ventilation.
Commentary: Evidence around respiratory health in those who use illicit drug users is meagre - but what there is suggests it is lousy. The authors noted the shorter duration of hospital admissions but didn't tease out the reasons. They suggest two possible reasons - that illicit drug users have fewer co-morbidities and are more likely to discharge against medical advice. The first of these, that illicit drug users have fewer co-morbidities, seems contentious. I don't doubt the second and it is a pity this wasn't included in this study as it almost certainly would have been available from the notes. We need to have a much greater awareness of respiratory disease in users - and if you do see someone who has just been in for an exacerbation of COPD then clearly a treatment review would be sensible.
Prevalence of skin problems and leg ulceration in a sample of young injecting drug users
Coull AF, Atherton I, Taylor A, Watterson AE. Harm Reduct J 2014, Aug;11(1):22
This study was based in needle exchanges and methadone clinics across Glasgow and they interviewed current and former drug injectors about their skin health. They used their own definitions of skin problems and divided the findings into: leg ulcers, lumps, track marks, abscesses, acid burns, broken skin, chronic wound, rashes, and other skin problems.
They found that 120 out of 200 (60%) reported skin problems. The most common problem was abscesses (75%), then lumps (48%), track marks (47%), leg ulcers (25%), acid burns (24%) and chronic wounds other than leg ulcers (23%). Some 15% of this sample had suffered a chronic leg ulcer (defined as having had the ulcer for >4 weeks).
Commentary: Everyone knows that injecting is hazardous - doctors from their very earliest days have seen enough "tissued" venflons and local infections to know that. The risks remain relatively small, although tangible, when done in ideal sterile conditions with experienced practitioners. These papers demonstrate some of the risks when it is pursued in occasionally sordid circumstances by enthusiastic (or desperate) amateurs with no training. Coull et al spend some time discussing the issue of leg ulceration and the Harm Reduction Journal paper should be read for that section alone. They make, quite rightly, the point that leg ulceration is most commonly the result of end-stage venous disease and in a relatively young injecting population it carries a very high tariff in terms of morbidity. I know I usually ask about groin injecting, given it is a marker of high risk behaviour, but I am now wondering if I should be extending that to a more general discussion and examination of skin health. Given 60% of injectors in the study had some kind of skin problem it is certainly warranted. And it then offers an opportunity to extend the discussion further into harm reduction, self care and, where necessary, treatment options.
The impact of methadone maintenance therapy on hepatitis C incidence among illicit drug users
Nolan S, Dias Lima V, Fairbairn N, Kerr T, Montaner J, Grebely J, Wood E. Addiction 2014, Jul 15
This study used data from three different cohort studies of illicit drug users in Vancouver. All the cohorts had used the same methods of data collection so they could be combined for analysis. They took the 1004 people who were HCV antibody negative and stratified them by exposure to methadone maintenance therapy (MMT). In total they found that 184 became infected - they had seroconverted.
The analysis, adjusted for confounders, showed that MMT exposure was protective against HCV seroconversion with an adjusted odds ratio of 0.47 (95% CI = 0.29-0.76). The confounding variables took account of a number of factors such as homelessness, syringe borrowing and daily injection of other stimulants such as cocaine and crystal methamphetamine. The sub-analysis showed that there was a dose-response protective effect with MMT exposure for each 6-month period of MMT.
Commentary: The long and the short of this paper is that it demonstrates that methadone maintenance protects against HCV infection. There has been a previous UK paper which showed a 60% reduction in HCV seroconversion but the overall number of seroconversions was small so caution is needed to draw conclusions. The evidence around methadone has always been good for demonstrating, at least with self-reported measures, that it reduces frequency of injecting, sharing of needles and syringes, and unsafe sex. One could infer, pretty strongly, that HCV seroconversion would be reduced, but it would be an assumption. So this is paper is important because it hasn't been absolutely demonstrated in the past. Again, and it's hard to believe that this case is still having to be made, methadone maintenance, is demonstrably effective. Any system that imposes limitations on methadone, which includes many countries but I'd also include some UK prisons, are doing so arbitrarily and contrary to the evidence and are likely to be exposing people to increased harm.
Misuse of the γ-aminobutyric acid analogues baclofen, gabapentin and pregabalin in the UK
Kapil V, Green JL, Le Lait M-C, Wood DM, Dargan PI. British Journal of Clinical Pharmacology 2014, Jul;78(1):190-1
This is presented as a long letter in the British Journal of Clinical Pharmacology and describes the results from an internet-based survey conducted in partnership with a global market research company. The company, GMI, has an established panel of millions and invitations were sent to existing members aged 16 to 59 years. The researchers were provided with raw data which were matched, anonymously, to demographic details. They looked at these alongside data on lifetime prevalence and frequency of misuse of baclofen, gabapentin and pregabalin. They also asked, if they had misused them, where they obtained their supply. They included questions on the use of cannabis and MDMA - but this was mainly for the purpose of comparing these data to the Crime Survey to check the sample was broadly representative.
The survey was completed by 1500 people and the lifetime prevalence of use of cocaine (8.1%), cannabis (28.1%), and ecstasy (8.2%) was comparable to the 2011/12 Crime Survey. The lifetime prevalence of the three GABA-analogues was 2.5% (n=38). The frequency of misuse was less than monthly in 37% and between weekly to monthly in 50%. Misuse of medication that had been legitimately prescribed was the sole source for 13.1% (n=5). Multiple sources were given in 37% and these included: health services (63.1%, n=24), family or acquaintances (57.8%, n=22), and from the internet (47.3%, n=18).
Commentary: Speaking to other people in primary care, not only those involved in substance misuse, there does seem to be a general appreciation for the abuse potential of medications like gabapentin and pregabalin. There is no easy way to determine in clinical practice, in a completely objective way, the presence or absence of neuropathic pain and like many things we have to rely on what the patient tells us and then make a judgement. Under-treating neuropathic pain will also have serious consequences for the individual. Misuse of these medications is certainly not vanishingly rare - but it does highlight that the source of the medications is not solely due to the diversion of legitimate prescriptions.
Screening and brief intervention for drug use in primary care: The ASPIRE randomized clinical trial
Saitz R, Palfai TP, Cheng DM, Alford DP, Bernstein JA, Lloyd-Travaglini CA, et al. JAMA 2014, Aug 6;312(5):502-13
This was a study in the United States which tested the effect of two brief counselling interventions in what they term "unhealthy drug use". This is defined as either illicit drug use or prescription drug misuse and was assessed by asking the second item from the Alcohol, Smoking, and Substance Misuse Involvement Screening Test (ASSIST). The interventions were either: a brief negotiated interview (BNI) which consisted of a single 10-15 minute structured interview by a health educator; or a motivational interviewing type intervention (MOTIV) which, in this case, consisted of 30-45 minutes of motivational interviewing with an offered 20-30 minute "booster" in a follow-up session.
The primary outcome was percentage of days using the main drug of misuse relevant to the individual. After screening and consent a total of 528 were randomised into one of the two groups or a no intervention control group. The main drug used was marijuana in 63% of cases, cocaine in 19% and opioids in 17%. At six months they had a 98% follow-up but there was no significant difference between any of the groups.
Brief intervention for problem drug use in safety-net primary care settings: A randomized clinical trial
Roy-Byrne P, Bumgardner K, Krupski A, Dunn C, Ries R, Donovan D, et al. JAMA 2014, Aug 6;312(5):492-501
This study took 868 patients who had reported problem drug use in the previous 90 days and randomised them to two interventions. One was care as usual and the other was a brief intervention consisting of a single session of motivational interviewing lasting around 30 minutes. A follow-up telephone booster was attempted within two weeks of the intervention.
The primary outcomes were self-reported days of problem drug use in the past 30 days and an Addiction Severity Index-Lite (ASI) Drug Use composite score. The results showed that the mean number of days of drug uses as 14.4 at baseline in the intervention group and 13.3 in the usual care. Three months after the intervention these were 11.9 and 9.8. This is not statistically significant. During the 12 months no significant treatment differences were found.
Commentary: Another couple of papers from the JAMA stable and this time they have published two RCTs on closely related topics but with very similar findings. Both related to finding substance misuse in primary care and assessed the benefit of brief interventions. I'm not sure that there is any appetite for screening tests for illicit drug in primary care in the UK - but that's a sad reflection of the health policy priorities of successive governments rather than an assessment of the evidence. (Goodness knows the NHS Health Screening programme doesn't follow the evidence.) In this case, there is strong evidence for the complete lack of effect.
Injection site infections and injuries in men who inject image- and performance-enhancing drugs: prevalence, risks factors, and healthcare seeking
Hope VD, McVeigh J, Marongiu A, Evans-Brown M, Smith J, Kimergård A, et al. Epidemiol Infect 2014, Apr 8:1-9
This study reported on injecting and image- and performance-enhancing drugs (IPEDs). They surveyed 366 male IPED injectors and found that 42% reported ever having redness, swelling and tenderness at injection sites. Just under 7% had ever had an abscess or open wound. Only 17% of those with redness, tenderness and swelling had sought treatment, while 76% of those with an abscess, sore or open wound had sought help. The most common sources were emergency clinics (A&E or walk-in clinic) and GP practices. Three-quarters reported visiting a needle and syringe exchange.
Overall, 159 out of the 366 had been to their GP in the past year but just 22 had been about something related to their IPED use. The men who went to their GP reported that their GP knew about their IPED use in 41% of cases. Just 20% had the hepatitis B immunisations and 18% had ever had a test for HCV with 28% ever having had a test for HIV. The use of other substances beyond steroids was part of the survey: 116 out of 366 reported injecting growth hormone in the past year; and 17 out of 366 reported injecting insulin.
The composition of anabolic steroids from the illicit market is largely unknown: implications for clinical case reports
Kimergård A, Breindahl T, Hindersson P, McVeigh J. QJM 2014, Jul;107(7):597-8
This is a short commentary that makes the point that most people who use anabolic steroids obtain them illicitly and that they are produced in unregulated "underground laboratories" where the usual standards of quality control are not applied. The blends of substances in these can be down to the manufacturer's own recipes and there is a risk of contamination with toxic chemicals or sterility may be compromised. The authors go on to suggest that "where possible, and when resources are available, drug vials, tablets and/or biological samples should be collected and submitted for analysis to identify the pharmacologically active substance, along with any contamination".
Commentary: The injections by users of IPEDs are going to be mostly intramuscular and subcutaneous, rather than intravenous, which changes the risk associated to a considerable degree, but clearly injection-related problems will still occur. Some of the other things that can be scraped from the study also make important contributions. For instance, injection of insulin was reported by 17 out of 366 men. OK, it's just under 5% but, still, it must have some significant hazard associated with it. It seems clear that consultations with this group remain a rarity and they are far more likely to be getting their advice via peers and internet forums but it gives us some good meat to add to the harm reduction bones.
The suggestion to keep specimens for analysis is well meant and is an important angle when it comes to considering the potential harms from the use of anabolic steroids. Certainly in the case of bacterial infection I can see how it would be relatively straightforward to send samples to microbiology. I am less clear on how, in the current system of NHS or independent providers, one would go about sending samples for pharmacological analysis and where this kind of specialist analysis could be obtained from within primary care. It's a counsel of perfection which doesn't consider the realities of practice. However, if you do know of a mechanism for this please share it on the SMMGP Forums.
nabolic-androgenic steroids and heroin use: A qualitative study exploring the connection
A. Cornford CS, Kean J, Nash A. Int J Drug Policy 2014, Jun 13
This short report reported on a study that aimed to further explore some of the socio-cultural explanations for the link between anabolic-androgenic steroids (AAS) and heroin. Some of this has been put down to similarity in social groupings and a biomedical explanation that they have similar effects on the neurochemistry. They conducted eight focus groups with a total of 30 individuals (who were heroin and non-heroin users) and they also had semi-structured interviews with two of the participants. They found that some users used AAS to reverse the effects of weight loss associated with heroin use. The participants also explained how they could demonstrate recovery by increasing in size. This was an important metric for the user and also for those close to the individual as well. A further factor was that being bigger made them more intimidating and that was useful in activities such as drug dealing.
Variability and dilemmas in harm reduction for anabolic steroid users in the UK: a multi-area interview study
Kimergård A, McVeigh J. Harm Reduct J 2014;11:19
This qualitative study digs into the topic of harm reduction for anabolic steroid users. They interviewed harm reduction services as well as users in England and Wales. More than anything there was huge variability in the provision of harm reduction services. Even the extent of needle and syringe exchange programmes is difficult to determine when peer-led processes can result in secondary distribution of needles and syringes. The co-location of needle and syringe exchange programmes can result in anabolic steroid users distancing themselves from this group. Anabolic steroid users regarded themselves as different from IDUs and the stigma associated with injecting drug use has far-reaching consequences. The authors discuss the possibility of extending services to include such checking liver function tests (LFTs) in "steroid clinics". However, the potential for false reassurance is also great and it can't be assumed there will be net benefit without appropriate studies.
Commentary: The association with heroin and AAS is well know and the brief report by Cornford et al is a bit of a gem for unpicking the relationship. Based out of primary care, it is highly relevant and the findings are not, unlike some studies, necessarily intuitive. It also makes a good counterpoint to the other study exploring harm reduction provision. There is an association between heroin and steroid use - however, the differences between the two groups also result in a difficult tension that impacts upon how anabolic steroid users access services. The provision of appropriate services to people who use anabolic steroids is an enormously complex undertaking and if you are looking at developing harm reduction services, or just want to glean a little more insight into consultations with this group, then the paper by Kimergård and McVeigh is highly recommended.