Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking

O’Malley, Stephanie S.; Zweben, Allen; Fucito, Lisa M.; Wu, Rongqian; Piepmeier, Mary; Ockert, David M.; Bold, Krysten W.; Petrakis, Ismene; Muvvala, Srinivas; Jatlow, Peter; Gueorguieva, Ralitza

doi:10.1001/jamapsychiatry.2017.3544

Cited by 84 publications

(78 citation statements)

References 65 publications

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“…26 Several studies have investigated the effect of varenicline on drinking parameters in alcohol use disorders previously. [14][15][16][17]26,27 Our finding that varenicline had no effect on alcohol abstinence corresponds to the results of 3 other studies. [14][15][16] Otherwise, our study confirms the finding of 2 previous studies that varenicline reduces the daily alcohol intake but has no positive effect on heavy drinking days.…”

Section: Discussionsupporting

confidence: 90%

“…In addition, concerns about the safety of varenicline in patients with cardiovascular or neuropsychiatric conditions have been raised. 17 Therefore, in our preliminary trial, we focused our investigation on the safety of varenicline for a group of patients with severe alcohol and nicotine dependence and organic comorbidities after detoxification. Furthermore, several outcome measures on drinking and smoking were assessed during the 12-week trial.…”

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confidence: 99%

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Efficacy of Varenicline in Patients With Severe Alcohol Dependence

Pfeifer

Fehr²

2019

J Clin Psychopharmacol

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Purpose/Background: Varenicline has proven its efficacy in the treatment of nicotine dependence, and there is also evidence that it could be helpful in the treatment of alcohol dependence. In our pilot study, we investigated the feasibility and acceptability of varenicline for the treatment of a population of patients with severe alcohol dependence and multiple somatic comorbidities after alcohol detoxification. Methods/Procedures: We conducted a phase II, double-blind, placebocontrolled randomized trial of daily oral varenicline versus a placebo in alcohol-dependent men and women after alcohol detoxification (n = 28). Following our study protocol, somatic conditions and adverse events were thoroughly monitored and several study end points were investigated (percentage of abstinent days for both alcohol and nicotine, number of standardized drinks and cigarettes per day, days of heavy drinking). Findings/Results: Compared with the placebo, varenicline did not have more side effects and did not provoke more adverse events. Patients in the varenicline group did not show a significantly higher percentage of alcohol abstinent days or fewer heavy drinking days. A trend significance was found for a reduced number of standard drinks per day (P = 0.06) in the varenicline group. Implications/Conclusions: In this pilot trial, varenicline was shown to be well tolerated by our study population of severely alcohol-dependent patients with somatic conditions. Varenicline did not sustain alcohol abstinence or reduce the number of heavy drinking days, but it did reduce the daily amount of alcohol consumed.

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Section: Discussionsupporting

confidence: 90%

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confidence: 99%

Efficacy of Varenicline in Patients With Severe Alcohol Dependence

Pfeifer

Fehr²

2019

J Clin Psychopharmacol

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“…; O'Malley et al . ), these results demonstrate that varenicline is a promising medication for tobacco cessation among T+CUs. Nabilone robustly attenuated cannabis withdrawal‐related changes in mood and sleep, was well‐tolerated, produced few side effects and appears to have lower abuse liability than smoked cannabis.…”

Section: Discussionsupporting

confidence: 58%

Varenicline and nabilone in tobacco and cannabis co‐users: effects on tobacco abstinence, withdrawal and a laboratory model of cannabis relapse

et al. 2018

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Tobacco and cannabis co-users (T+CUs) have poor cannabis cessation outcomes, but the mechanisms underlying this are not well understood. This laboratory study examined the effects of (1) the partial nicotinic agonist, varenicline, on tobacco cessation among T+CUs, and (2) varenicline, alone, and when combined with the cannabinoid agonist nabilone, on cannabis withdrawal and a laboratory model of cannabis relapse. Non-treatment-seeking T+CUs were randomized to active-varenicline or placebo-varenicline, and completed a 15-day outpatient phase; varenicline was titrated to 1 mg BID during days 1-8, and participants were instructed to abstain from tobacco during days 9-15. Participants then moved inpatient for 16 days, where they continued their outpatient medication and tobacco abstinence. Inpatient testing included two, 8-day medication periods, where active-nabilone and placebo-nabilone were administered in counterbalanced order, and measures of acute cannabis effects (days 1-2), withdrawal (days 4-5) and 'relapse' (days 6-8) were collected. Participants in the active-varenicline group were more likely to achieve cotinine-verified tobacco abstinence during the outpatient period versus placebo-varenicline group (46 percent versus 24 percent, respectively), and also reported less mood disturbance and cigarette craving while inpatient. Active-nabilone attenuated cannabis withdrawal in both groups but did not affect cannabis relapse. Regression analyses revealed that two tobacco-related variables, i.e. age of first cigarette use, and cigarette craving while inpatient, were independent predictors of cannabis relapse outcomes. Thus, varenicline holds promise in this population, as a tool to examine the effects of tobacco abstinence on cannabis use outcomes, and as a component of smoking cessation treatments targeting T+CUs.

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“…Indeed, varenicline has shown mixed results in reducing alcohol consumption in human studies (de Bejczy et al, 14 2015;Litten et al, 2013;Mitchell et al, 2012;O'Malley et al, 2018;Plebani et al, 2013), and naltrexone and acamprosate fail to reduce cigarette smoking (Kahler et al, 2017;Fucito et al, 2012). Dual pharmacological treatment, such as combining naltrexone with nicotine replacement therapy, has been incorporated in trials to enhance the likelihood of successful alcohol and smoking abstinence (Kahler et al, 2017;Toll et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

Unequal interactions between alcohol and nicotine co-consumption: Suppression and enhancement of concurrent drug intake

DeBaker

Moen

Robinson

et al. 2019

Preprint

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Rationale Alcohol and nicotine addiction are prevalent conditions that co-occur. Despite the prevalence of co-use, factors that influence the suppression and enhancement of concurrent alcohol and nicotine intake are largely unknown.Objectives Our goals were to assess how nicotine abstinence and availability influenced concurrent alcohol consumption, and to determine the impact of quinine adulteration of alcohol on aversion resistant alcohol consumption and concurrent nicotine consumption.Methods Male and female C57BL/6J mice voluntarily consumed unsweetened alcohol, nicotine and water in a chronic 3-bottle choice procedure. In Experiment 1, nicotine access was removed for 1 week and re-introduced the following week, while the alcohol and water bottles remained available at all times. In Experiment 2, quinine (100-1000 μM) was added to the 20% alcohol bottle, while the nicotine and water bottles remained unaltered. ResultsIn Experiment 1, we found that alcohol consumption and preference were unaffected by the presence or absence of nicotine access in both male and female mice. In Experiment 2a, we found that quinine temporarily suppressed alcohol intake and enhanced concurrent nicotine, but not water, preference in both male and female mice. In Experiment 2b, chronic quinine suppression of alcohol intake increased nicotine consumption and preference in female mice without affecting water preference, whereas it increased water and nicotine preference in male mice.Conclusions Quinine suppression of alcohol consumption enhanced the preference for concurrent nicotine preference in male and female mice, suggesting that mice compensate for the quinine adulteration of alcohol by increasing their nicotine preference.3

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Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking

Abstract: clinicaltrials.gov Identifier: NCT01553136.

Cited by 84 publications

References 65 publications

Efficacy of Varenicline in Patients With Severe Alcohol Dependence

Efficacy of Varenicline in Patients With Severe Alcohol Dependence

Varenicline and nabilone in tobacco and cannabis co‐users: effects on tobacco abstinence, withdrawal and a laboratory model of cannabis relapse

Unequal interactions between alcohol and nicotine co-consumption: Suppression and enhancement of concurrent drug intake

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