A qualitative exploration of the experiences of transdermal alcohol sensor devices amongst people in receipt of treatment for alcohol use disorder.

Introduction: Transdermal alcohol sensors (TAS) have the potential to be used as a clinical tool in alcohol treatment, but there is limited research with individuals with alcohol dependence using TAS. Our study is a qualitative evaluation of the views of people attending alcohol treatment and their experiences of wearing the BACtrack Skyn, within alcohol services in South London. Methods: Participants with alcohol dependence wore a BACtrack Skyn TAS for one week and met with the researcher every two days, for a total of four meetings (for example: Monday, Wednesday, Friday, and Monday). In the final meeting, a post-wear survey (on their physical, social and comfort experience of the TAS) and semi-structured interview were completed. The Technology Acceptance Model (TAM) informed the topic guide and data analysis. Results: Adults (N = 16) receiving alcohol treatment were recruited. Three core topics guided analysis: perceived usefulness, perceived ease of use and attitudes towards use. Participants found the TAS easy to wear and felt positive about its appearance and comfort. The only challenges reported were side effects, mostly skin irritation. The main two perceived uses were 1) TAS working as a drinking deterrent and 2) reducing daily breathalyser visits during detox. Conclusion: Findings support the use of TAS amongst alcohol service users. Wearing the TAS for one week was acceptable and feasible for objective alcohol concentration measurement. Participants reported high perceived ease of use and usefulness of the Skyn in the context of alcohol treatment. These results are encouraging for the use of TAS in clinical settings.

Comparison of transdermal alcohol concentration and self-reported alcohol consumption in people with alcohol dependence attending community alcohol treatment services.

AIM: We aimed to assess the accuracy and wearability of a transdermal alcohol sensor (TAS) (BACtrack Skyn) with people currently receiving treatment at alcohol services. METHOD: A mixed methods observational study involving three NHS alcohol services in south London was conducted. All participants (7=male, 9=female) wore a TAS for 1 week and met with the researcher every other weekday to complete the TAS data download and a TimeLine Follow Back (TLFB). At the end of the week, a post-wear survey was completed. Transdermal Alcohol Concentration (TAC) from the TAS was compared to the TLFB. Post-wear survey responses, attendance voucher incentives and descriptive TAS data (removals, missing and skin temperature data) were analysed. We investigated different drinking event thresholds changing the criteria of TAC level and length of time TAC was increased and analysed each drinking threshold sensitivity, specificity, positive and negative predicative values, and percentage accuracy classification. RESULTS: The TAS recorded the number of alcohol-drinking days with a high degree of accuracy compared to the TLFB as gold-standard. However, of the participation time of the 16 participants, 14.5% of the TAS data was missing in output and 16.4% of the recorded data suggests the TAS was not currently being worn. Of the data recorded, in line with the drinking event threshold of >15 ug/l TAC, >15minutes, we found that sensitivity = 93%, specificity = 84% and a Pearson correlation of r(16) =.926, p = <.001, BCa 95% CI [.855 -.981]. The threshold with the highest accuracy was TAC>15 ug/l, >60minutes which classified alcohol events with 90% accuracy, AUC =.910, sensitivity = 90%, specificity = 96%. The post-wear survey reported that most participants found it comfortable and that wearing it did not interfere with daily activities. Six participants reported side effects, including itching and a rash, but these would not deter them from wearing it again with all six reporting they would wear the TAS again and for longer than one week. CONCLUSIONS: The TAS did not capture every drinking event that was self-reported but maintained a high correlation. There were instances of missing TAS data and TAS removals. Overall, our findings would support the acceptability and feasibility of TAS as a tool that could be used in clinical settings for objective alcohol monitoring with patients being responsible for the TAS.

Accuracy of transdermal alcohol monitoring devices in a laboratory setting.

The development of transdermal alcohol sensors (TASs) presents a new method to monitor alcohol consumption with the ability to objectively measure data 24/7. We aimed to evaluate the accuracy of two TASs (BACtrack Skyn and Smart Start BARE) in a laboratory setting. Thirty-two adults received a dose of ethanol 0.56 g/kg body weight as a 20% solution while wearing the two TASs and provided Breath Alcohol Concentration (BrAC) measurements for 3.5 h postalcohol consumption. Pearson's correlations and repeated measures analysis of variance tests were conducted on the peak, time-to-peak, and area under the curve data. Bland-Altman plots were derived. A time series analysis and cross-correlations were conducted to adjust for time lag. Both TASs were able to detect alcohol and increase within 20 min. BrAC peaked significantly quicker than Skyn and BARE. BrAC and Skyn peaks were negatively significantly correlated (r = -0.381, P = .035, n = 31), while Skyn and BARE peaks were positively significantly correlated (r = 0.380, P = .038, n = 30). Repeated measures analysis of variance found a significant difference between BrAC, Skyn, and BARE (F(1.946, 852.301) = 459.873, P < .001)). A time series analysis found when BrAC-Skyn and BrAC-BARE were adjusted for the delay to peak, and there was still a significant difference. Failure rates: 1.7% (Skyn) and 4.8% (BARE). Some evidence was obtained for TAS validity as both consistently detected alcohol. Failure rates and time lag show improvements in older device generations. However, neither TAS presented strong equivalence to the breathalyser even when the lag time was adjusted. With further testing and technology advancements, TAS could be a potential alcohol monitoring tool. Two of the newest TAS devices were worn in laboratory conditions for one afternoon to compare their accuracy of alcohol monitoring to a breathalyser. Findings suggest that the two TASs (BACtrack Skyn and SmartStart BARE) recorded significantly similar data postalcohol consumption, but not with the breathalyser.

Adjunctive Medication Management and Contingency Management to enhance adherence to acamprosate for alcohol dependence: the ADAM trial RCT.

Background: Acamprosate is an effective and cost-effective medication for alcohol relapse prevention but poor adherence can limit its full benefit. Effective interventions to support adherence to acamprosate are therefore needed. Objectives: To determine the effectiveness of Medication Management, with and without Contingency Management, compared to Standard Support alone in enhancing adherence to acamprosate and the impact of adherence to acamprosate on abstinence and reduced alcohol consumption. Design: Multicentre, three-arm, parallel-group, randomised controlled clinical trial. Setting: Specialist alcohol treatment services in five regions of England (South East London, Central and North West London, Wessex, Yorkshire and Humber and West Midlands). Participants: Adults (aged 18 years or more), an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of alcohol dependence, abstinent from alcohol at baseline assessment, in receipt of a prescription for acamprosate. Interventions: (1) Standard Support, (2) Standard Support with adjunctive Medication Management provided by pharmacists via a clinical contact centre (12 sessions over 6 months), (3) Standard Support with adjunctive Medication Management plus Contingency Management that consisted of vouchers (up to £120) to reinforce participation in Medication Management. Consenting participants were randomised in a 2 : 1 : 1 ratio to one of the three groups using a stratified random permuted block method using a remote system. Participants and researchers were not blind to treatment allocation. Main outcome measures: Primary outcome: self-reported percentage of medication taken in the previous 28 days at 6 months post randomisation. Economic outcome: EuroQol-5 Dimensions, a five-level version, used to calculate quality-adjusted life-years, with costs estimated using the Adult Service Use Schedule. Results: Of the 1459 potential participants approached, 1019 (70%) were assessed and 739 (73 consented to participate in the study, 372 (50%) were allocated to Standard Support, 182 (25%) to Standard Support with Medication Management and 185 (25%) to Standard Support and Medication Management with Contingency Management. Data were available for 518 (70%) of participants at 6-month follow-up, 255 (68.5%) allocated to Standard Support, 122 (67.0%) to Standard Support and Medication Management and 141 (76.2%) to Standard Support and Medication Management with Contingency Management. The mean difference of per cent adherence to acamprosate was higher for those who received Standard Support and Medication Management with Contingency Management (10.6%, 95% confidence interval 19.6% to 1.6%) compared to Standard Support alone, at the primary end point (6-month follow-up). There was no significant difference in per cent days adherent when comparing Standard Support and Medication Management with Standard Support alone 3.1% (95% confidence interval 12.8% to -6.5%) or comparing Standard Support and Medication Management with Standard Support and Medication Management with Contingency Management 7.9% (95% confidence interval 18.7% to -2.8%). The primary economic analysis at 6 months found that Standard Support and Medication Management with Contingency Management was cost-effective compared to Standard Support alone, achieving small gains in quality-adjusted life-years at a lower cost per participant. Cost-effectiveness was not observed for adjunctive Medication Management compared to Standard Support alone. There were no serious adverse events related to the trial interventions reported. Limitations: The trial's primary outcome measure changed substantially due to data collection difficulties and therefore relied on a measure of self-reported adherence. A lower than anticipated follow-up rate at 12 months may have lowered the statistical power to detect differences in the secondary analyses, although the primary analysis was not impacted. Conclusions: Medication Management enhanced with Contingency Management is beneficial to patients for supporting them to take acamprosate. Future work: Given our findings in relation to Contingency Management enhancing Medication Management adherence, future trials should be developed to explore its effectiveness and cost-effectiveness with other alcohol interventions where there is evidence of poor adherence. Trial registration: This trial is registered as ISRCTN17083622 https://doi.org/10.1186/ISRCTN17083622. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 22. See the NIHR Journals Library website for further project information.

Many people who are trying to stop drinking alcohol can find it difficult to remain alcohol free. There is a medication called acamprosate (Campral) that can reduce cravings thereby increasing the likelihood of abstinence. However, some people have trouble taking the right amount of acamprosate tablets needed every day at the right time, preferably at mealtimes. This means the medication is not as effective. We have tested some new ways to help support people taking acamprosate. We tested three different strategies to find the best way to support people taking acamprosate. We recruited 739 people aged 18 and over who were receiving alcohol treatment to stop drinking and were taking acamprosate. We randomly allocated these people to three groups. The first was Standard Support, the usual support people receive when taking acamprosate. The second group received Standard Support plus Medication Management. This consisted of 12 telephone calls over 6 months with a trained pharmacist to discuss the importance of taking the right amount of the medication, how the medication works and strategies to help people take the medication correctly. The third group received Standard Support, Medication Management and Contingency Management. This involved giving people shopping vouchers for participating with Medication Management calls. The maximum value of vouchers per person was £120. People who were in the group receiving Medication Management and Contingency Management took a greater number of acamprosate tablets. We also found that Medication Management plus Contingency Management was more cost-effective; there were greater gains in health with a smaller cost per person compared to Standard Support alone. This shows that there is likely to be a benefit to patients of Medication Management plus Contingency Management for supporting people taking acamprosate.

Efficacy of psychosocial interventions to reduce alcohol use in comorbid alcohol use disorder and alcohol-related liver disease: a systematic review of randomized controlled trials.

This systematic review (PROSPERO CRD42021234598) fills a gap in the literature by assessing the efficacy of psychosocial interventions in patients with alcohol use disorder and alcohol-related liver disease (ARLD), focusing on drinking reduction and abstinence as intervention goals. A systematic search for randomized controlled trials (RCTs) was conducted across various databases. Study screening and data extraction were conducted independently by two reviewers. The data were presented through narrative synthesis. Primary outcomes were alcohol reduction and abstinence at the longest follow-up. Ten RCTs were included, evaluating interventions such as cognitive behavioral therapy (CBT), motivational enhancement therapy (MET), motivational interviewing, or peer support. The total population included 1519 participants. Four studies included a combination of more than one intervention, and two trialed an integrated approach, including medical and psychosocial management. A significant reduction was observed with MET, while abstinence was observed with peer support, MET, and CBT/MET within integrated treatment. The overall certainty of the evidence was moderate. Six studies presented a low risk of bias, one had some concerns, and three were high risk. The findings highlight the potential of psychosocial interventions, with MET being repeatedly associated with improved outcomes. Integrated treatment also demonstrated a promising role in ARLD. Future research should head toward improving the robustness and quality of the evidence. It should also aim to further tailor and trial new psychosocial interventions on this specific clinical population. This will enhance the translation of the evidence into real-world settings.

Acceptability and Feasibility of Wearable Transdermal Alcohol Sensors: Systematic Review.

BACKGROUND: Transdermal alcohol sensors (TASs) have the potential to be used to monitor alcohol consumption objectively and continuously. These devices can provide real-time feedback to the user, researcher, or health professional and measure alcohol consumption and peaks of use, thereby addressing some of the limitations of the current methods, including breathalyzers and self-reports. OBJECTIVE: This systematic review aims to evaluate the acceptability and feasibility of the currently available TAS devices. METHODS: A systematic search was conducted in CINAHL, EMBASE, Google Scholar, MEDLINE, PsycINFO, PubMed, and Scopus bibliographic databases in February 2021. Two members of our study team independently screened studies for inclusion, extracted data, and assessed the risk of bias. The study's methodological quality was appraised using the Mixed Methods Appraisal Tool. The primary outcome was TAS acceptability. The secondary outcome was feasibility. The data are presented as a narrative synthesis. RESULTS: We identified and analyzed 22 studies. Study designs included laboratory- and ambulatory-based studies, mixed designs, randomized controlled trials, and focus groups, and the length the device was worn ranged from days to weeks. Although views on TASs were generally positive with high compliance, some factors were indicated as potential barriers and there are suggestions to overcome these. CONCLUSIONS: There is a lack of research investigating the acceptability and feasibility of TAS devices as a tool to monitor alcohol consumption in clinical and nonclinical populations. Although preliminary evidence suggests their potential in short-term laboratory-based studies with volunteers, more research is needed to establish long-term daily use with other populations, specifically, in the clinical and the criminal justice system. TRIAL REGISTRATION: PROSPERO CRD42021231027; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231027.

Accuracy of Wearable Transdermal Alcohol Sensors: Systematic Review.

BACKGROUND: There are a range of wearable transdermal alcohol sensors that are available and are being developed. These devices have the potential to monitor alcohol consumption continuously over extended periods in an objective manner, overcoming some of the limitations of other alcohol measurement methods (blood, breath, and urine). OBJECTIVE: The objective of our systematic review was to assess wearable transdermal alcohol sensor accuracy. METHODS: A systematic search of the CINAHL, Embase, Google Scholar, MEDLINE, PsycINFO, PubMed, and Scopus bibliographic databases was conducted in February 2021. In total, 2 team members (EB and SH) independently screened studies for inclusion, extracted data, and assessed the risk of bias. The methodological quality of each study was appraised using the Mixed Methods Appraisal Tool. The primary outcome was transdermal alcohol sensor accuracy. The data were presented as a narrative synthesis. RESULTS: We identified and analyzed 32 studies. Study designs included laboratory, ambulatory, and mixed designs, as well as randomized controlled trials; the length of time for which the device was worn ranged from days to weeks; and the analyzed sample sizes ranged from 1 to 250. The results for transdermal alcohol concentration data from various transdermal alcohol sensors were generally found to positively correlate with breath alcohol concentration, blood alcohol concentration, and self-report (moderate to large correlations). However, there were some discrepancies between study reports; for example, WrisTAS sensitivity ranged from 24% to 85.6%, and specificity ranged from 67.5% to 92.94%. Higher malfunctions were reported with the BACtrack prototype (16%-38%) and WrisTAS (8%) than with SCRAM (2%); however, the former devices also reported a reduced time lag for peak transdermal alcohol concentration values when compared with SCRAM. It was also found that many companies were developing new models of wearable transdermal alcohol sensors. CONCLUSIONS: As shown, there is a lack of consistency in the studies on wearable transdermal alcohol sensor accuracy regarding study procedures and analyses of findings, thus making it difficult to draw direct comparisons between them. This needs to be considered in future research, and there needs to be an increase in studies directly comparing different transdermal alcohol sensors. There is also a lack of research investigating the accuracy of transdermal alcohol sensors as a tool for monitoring alcohol consumption in clinical populations and use over extended periods. Although there is some preliminary evidence suggesting the accuracy of these devices, this needs to be further investigated in clinical populations. TRIAL REGISTRATION: PROSPERO CRD42021231027; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231027.

The rates and measurement of adherence to acamprosate in randomised controlled clinical trials: A systematic review.

AIM: The current research aims to systematically review the rates of adherence reported in randomised controlled clinical trials of acamprosate. It also sought to determine the reliability of the adherence monitoring and measurement methods used in these trials. METHODS: The protocol for this review was pre-registered (PROSPERO: CRD42021230011). A search of the literature was conducted using OVID MEDLINE, Embase and PsycINFO from database inception to January 2021. Randomised controlled trials with a minimum sample size of 10 per treatment arm that compared the efficacy of acamprosate with placebo or other active medication in adults with a diagnosis of alcohol dependence were included. Data on rates of adherence, methods of measurement and monitoring of adherence was extracted from eligible studies independently in duplicate by two reviewers. A weighted mean adherence rate was calculated. The reliability of adherence monitoring methods was determined by calculating an adherence-assurance score based on the adherence monitoring method used. Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Fifteen studies met the eligibility criteria involving 4,450 participants (2,480 participants in the placebo arms). A mean adherence rate of 88% (54.2-95.0%) was reported across studies that reported the percentage of medication taken. A mean adherence rate of 84.9% (56.4-91.3%) was reported for trials that reported the percentage of participants taking more than 80% of medication prescribed. There is low confidence in the methods used to monitor adherence with all clinical trials having a low adherence-assurance rating. Risk of bias was judged to be high for all included studies. CONCLUSIONS: Adherence to acamprosate in clinical trials can be poor with low confidence in the methods used to measure it. Adherence rates therefore might not be accurate, which has implications for determining the efficacy of acamprosate.

Identification of factors influencing tampering of codeine-containing medicines in England: a qualitative study.

BACKGROUND: Tampering of psychoactive medicines presents challenges to regulation and public health. However, little is currently known about what influences the decisions to treat codeine-containing medicines (CCM) with cold water extraction (CWE) from the perspective of individuals employing these techniques. The article identifies factors influencing utilisation of CWE to separate codeine from compounded analgesics, such as paracetamol and ibuprofen, found in CCM. METHODS: Purposive sampling of 27 participants residing in England who took part in a qualitative interview. Of these, 14 individuals (11 males and 3 females) reported tampering of psychoactive medicines, and the relevant transcripts were included in the analyses for the study. Participants were recruited from one addiction treatment service and from an online survey. The mean age of the participants was 31.5 years (range = 18-42 years). Qualitative data analysis followed the processes of iterative categorization (IC). The codes 'harm reduction', 'information sources' and 'changes on the drug markets' were grouped and summarised. The coding of the data was done in a Microsoft® Word document. RESULTS: Two groups of participants were identified in the data analysis: (i) individuals who used CCM (n = 5), and (ii) individuals who used CCM and heroin (n = 9). Participants in both groups used CWE due to concerns of paracetamol overdose from the use of excessive dosages of CCM. For both of them, information obtained from the internet encouraged the use of CWE. Participants using CCM described how the many steps involved in conducting CWE, including sourcing codeine boxes from pharmacies (over the counter), presented a barrier against using CWE. Participants using CCM and heroin explained how reduced availability in the local heroin supply influenced utilisation of CWE techniques to maintain their use of opioids and avoid withdrawal. Withdrawal symptoms and cravings outweighed the concerns about the quality of the extracted codeine mixtures in this participant group, especially the ability of CWE to remove paracetamol and tablet fillers. CONCLUSIONS: Utilisation of CWE of codeine was influenced by several factors including drug market supply, the availability of detailed information on the internet about CWE and restrictions on codeine sourcing in pharmacies. Risks identified with CWE include consumption of unknown doses of paracetamol if the CWE techniques are not used correctly. Attempts at extracting codeine from CCM should be considered in risk assessments of opioid medicines.