Use of Novel Technology-Based Techniques to Improve Alcohol-Related Outcomes in Clinical Trials

Gurvich, Eugenia M.; Kenna, George A.; Leggio, Lorenzo

doi:10.1093/alcalc/agt134

Cited by 27 publications

(17 citation statements)

References 72 publications

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“…Pending development of devices that can monitor actual BAC unobtrusively in real time 30 , we used estimated BAC as an alternative measure of drinking intensity that has been evaluated in studies of brief motivational interventions and moderate drinking protocols 31,32 . Based on daily reports, we estimated BAC based on drink number, drinking duration and total body water 28 .…”

Section: Discussionmentioning

confidence: 99%

Reduction of Alcohol Drinking in Young Adults by Naltrexone

O’Malley¹,

Corbin²,

Leeman³

et al. 2015

J. Clin. Psychiatry

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Objective Naltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in heavy drinking young adults. Methods Randomized, double-blind, placebo-controlled study, outpatient research center, March 2008-January 2012. Participants were ages 18-25, reporting ≥ 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All received a personalized feedback session and brief counseling every other week. Primary outcomes were percent days heavy drinking (PHDD) and percent days abstinent (PDA) over the 8-week treatment period. Secondary outcomes included drinks/drinking day and percent days with estimated blood alcohol levels ≥0.08 g/dL. Results Of 140 randomized, 128 began treatment, comprising the evaluable sample. During treatment, PHDD (Naltrexone M=21.60, SD=16.05; Placebo M=22.90, SD=13.20) (p=0.58) and PDA (Naltrexone M=56.60, SD=22.52; Placebo M=62.50, SD=15.75) (p=0.39) did not differ by group. Naltrexone significantly reduced drinks per drinking day (Naltrexone M=4.90, SD=2.28; Placebo M=5.90, SD=2.51) (p=0.009) and percentage of drinking days with estimated BAC ≥0.08 g/dL (Naltrexone M=35.36, SD=28.40; Placebo M=45.74, SD=26.80) (p=0.042). There were no serious adverse events. Sleepiness was more common with naltrexone. Conclusions Naltrexone did not reduce frequency of drinking or heavy drinking days, but reduced secondary measures of drinking intensity. While effects were modest, the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce their drinking. Registration clinicaltrials.gov NCT00568958

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Section: Discussionmentioning

confidence: 99%

Reduction of Alcohol Drinking in Young Adults by Naltrexone

O’Malley¹,

Corbin²,

Leeman³

et al. 2015

J. Clin. Psychiatry

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“…This method is primarily intended to assess current intoxication, rather than ongoing abstinence (5). Transdermal alcohol monitors allow for continuous monitoring of drinking, but are relatively expensive, and concerns exist regarding their feasibility and convenience (6). High levels of enzymes such as gamma-glutamyl-tansferase (GGT) can be detected in alcohol-dependent people, but have limited utility in detecting low levels of drinking, or infrequent, non-chronic binge drinking (7,8).…”

Section: Introductionmentioning

confidence: 99%

High levels of agreement between clinic-based ethyl glucuronide (EtG) immunoassays and laboratory-based mass spectrometry

Leickly

McDonell

Vilardaga

et al. 2015

The American Journal of Drug and Alcohol Abuse

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Background Immunoassay urine drug screening cups that detect use for two or more days are commonly used in addiction treatment settings. Until recently, there has been no comparable immunoassay test for alcohol use in these settings. Objectives The aim of this study was to assess the agreement of a commercially available ethyl glucuronide immunoassay (EtG-I) test conducted at an outpatient addiction clinic and lab-based EtG mass spectrometry (EtG-MS) conducted at a drug testing laboratory at three cut-off levels. High agreement between these two measures would support the usefulness of EtG-I as a clinical tool for monitoring alcohol use. Methods Forty adults with co-occurring alcohol dependence and serious mental illnesses submitted 1068 urine samples over a 16-week alcohol treatment study. All samples were tested using EtG-I on a benchtop analyzer and 149 were randomly selected for EtG-MS analysis at a local laboratory. Agreement was defined as the number of samples where EtG-I and EtG-MS were both above or below a specific cut-off level. Agreement was calculated at low cut-off levels (100 and 250 ng/ml), as well as at a higher cut-off level (500 ng/ml) recommended by most by commercial drug testing laboratories. Results Agreement between EtG-I and EtG-MS was high across all cut-off levels (90.6% at 100 ng/ml, and 96.6% at 250 and 500 ng/ml). Conclusions EtG immunoassays conducted at low cut-off levels in point-of-care testing settings have high agreement with lab-based EtG-MS. EtG-I can be considered a useful clinical monitoring tool for alcohol use in community-based addiction treatment settings.

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“…Placebo and topiramate were encapsulated and indistinguishable from one another. Daily Assessments: We used IVR to administer survey questions by telephone (Gurvich, Kenna, & Leggio, 2013). Patients were trained to use the IVR and each was given a wallet- sized, follow-along guide detailing each question, including answer options to assist them with the first few IVR calls.…”

Section: Methodsmentioning

confidence: 99%

GRIK1 genotype and daily expectations of alcohol’s positive effects moderate the reduction of heavy drinking by topiramate.

Kranzler

Armeli

Tennen

et al. 2014

Experimental and Clinical Psychopharmacology

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Using retrospective reports obtained during treatment visits in 138 heavy drinkers, we found that topiramate’s reduction of heavy drinking was moderated by a polymorphism (rs2832407) in GRIK1, which encodes the GluK1 kainate subunit (Kranzler et al., 2014a). A subsequent analysis of that 12-week topiramate treatment trial showed similar effects of medication and genotype on daily drinking reports obtained via interactive voice response technology (IVR; Kranzler et al., 2014b). Specifically, rs2832407*C-allele homozygotes treated with topiramate reported lower levels of drinking than those receiving placebo. This group also had the largest decreases in the expected positive effects of drinking (i.e., expectancies) and desire to drink. To extend that analysis, which focused on how mean levels of desire and expectancies changed over time with treatment, we used a within-person approach to examine whether daily variation in expectancies and desire to drink interact with topiramate treatment and genotype to predict nighttime drinking levels. In contrast to the previous analysis (Kranzler et al., 2014b), here we focus on whether alcohol expectancies and desire to drink moderate the effects of topiramate on drinking. Results showed a three-way interaction of daily expectancies with genotype and medication, such that the protective effect of topiramate on nighttime drinking among rs2832407*C-allele homozygotes was decreased on days characterized by relatively high levels of anticipated positive effects of alcohol. There was no moderating effect of desire to drink or negative alcohol expectancies. Thus, there is specific moderation of the effects of topiramate by both genotype and cognitive process.

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Use of Novel Technology-Based Techniques to Improve Alcohol-Related Outcomes in Clinical Trials

Cited by 27 publications

References 72 publications

Reduction of Alcohol Drinking in Young Adults by Naltrexone

Reduction of Alcohol Drinking in Young Adults by Naltrexone

High levels of agreement between clinic-based ethyl glucuronide (EtG) immunoassays and laboratory-based mass spectrometry

GRIK1 genotype and daily expectations of alcohol’s positive effects moderate the reduction of heavy drinking by topiramate.

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