Dataset Information

Effects of Varenicline Alone and in Combination With Low-dose Naltrexone on Alcohol-primed Smoking in Heavy-drinking Tobacco Users: A Preliminary Laboratory Study.

ABSTRACT: OBJECTIVES:Heavy-drinking tobacco users are less likely to successfully quit smoking than their moderate-drinking counterparts, even when they are prescribed smoking cessation medication. One strategy for improving treatment outcomes in this subgroup of tobacco users may be to combine medication therapies to target both alcohol and tobacco use simultaneously. Adding naltrexone to frontline smoking cessation treatments may improve treatment outcomes in this group. METHOD:This double-blind, placebo-controlled human laboratory study examined the effects of varenicline (2?mg/d) and varenicline (2?mg/d), combined with a low dose of naltrexone (25?mg/d) on alcohol-primed smoking behavior in a laboratory model of smoking relapse in heavy-drinking tobacco users (n?=?30). Participants attended a laboratory session and received an alcohol challenge (target breath alcohol concentration?=?0.030?g/dL). They completed a smoking delay task that assessed their ability to resist smoking followed by an ad libitum smoking phase (primary outcomes). They also provided ratings of subjective drug effects and craving, and carbon monoxide levels were measured after smoking (secondary outcomes). RESULTS:Participants receiving varenicline monotherapy delayed smoking longer and smoked fewer cigarettes than those on placebo. Participants receiving varenicline?+?low-dose naltrexone did not delay smoking longer than those receiving varenicline alone. Participants in both active medication arms smoked fewer cigarettes ad libitum than those receiving placebo. CONCLUSIONS:Varenicline can improve smoking outcomes even after an alcohol prime, supporting its use in heavy drinkers who wish to quit smoking. Findings did not support increased efficacy of combined varenicline?+?low-dose naltrexone relative to varenicline monotherapy.

SUBMITTER: Roberts W

PROVIDER: S-EPMC5970035 | biostudies-literature | 2018 May/Jun

REPOSITORIES: biostudies-literature

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Project description:Post hoc analyses of 2 randomized controlled trials suggest naltrexone may reduce alcohol use and improve smoking cessation outcomes among heavy drinkers receiving smoking cessation treatment. However, no studies have been conducted specifically to examine naltrexone for this purpose or to test whether naltrexone has benefit when added to smoking cessation counseling that explicitly addresses heavy drinking.We recruited heavy-drinking smokers from the community and randomized them to receive 10 weeks of either (i) 50 mg naltrexone (n = 75) or (ii) placebo (n = 75) daily. Participants received 6 weeks of transdermal nicotine patch and 6 sessions of counseling that addressed both heavy drinking and smoking. Participants were followed for 26 weeks after their target quit smoking date.Across medication conditions, there were substantial reductions at follow-up in percent heavy drinking days (primary outcome) and average drinks per week (secondary outcome). However, participants receiving naltrexone did not differ significantly from those receiving placebo on percent heavy drinking days (effect size d = -0.04, 95% CI [-0.30, 0.22], p = 0.76) or average drinks per week (d = -0.09, 95% CI [-0.35, 0.18], p = 0.54) during follow-up. Naltrexone compared to placebo was not associated with a significant increase in smoking abstinence rates during follow-up, odds ratio = 0.93, 95% CI [0.46, 1.86], p = 0.83. The effect of naltrexone on these outcomes was not significantly moderated by current alcohol dependence or gender.Results indicate that heavy-drinking smokers, including those with current alcohol dependence, can make substantial reductions in drinking in the context of smoking cessation treatment. However, this study provided no evidence that naltrexone is efficacious for enhancing reductions in drinking or improving smoking cessation in this population. Limitations of this study included lower-than-desired sample size and modest adherence to study medication.

Project description:BACKGROUND:Tobacco use and heavy episodic drinking (HED) commonly co-occur in young adults. We developed and tested usability of the Smoking Tobacco and Drinking (STAND) intervention for young adults delivered on Facebook. METHODS:To inform the intervention, focus groups were held with 25 young adults age 18 to 25 (12% female; Mean age?=?20.4) who smoked cigarettes and reported at least one HED episode in the past month. Facebook intervention posts (N?=?180) were tailored to readiness to quit smoking, and tested in two private Facebook behavioral change groups (Ready, Not Ready) with N?=?29 young adults (10% female; Mean age?=?20.8). Participants flagged posts in need of change, and we assessed engagement (comment frequency). RESULTS:Focus groups revealed preference for changing one substance at a time and greater receptivity to quitting smoking than reducing drinking. Mean comments per post were 5.3 (SD?=?1.1) in Ready groups and 11.7 (SD?=?5.1) in Not Ready groups; 94/180 (52.2%) posts were flagged for change. The level of engagement and the flagging of posts for change did not differ by group or by whether the post targeted tobacco, alcohol, or both substances combined (all p?>?.10). Overall, STAND was rated as easy to understand, providing sound advice, worthy of recommendation, and helpful (all agreement 100% among Ready; 50-70% among Not Ready). CONCLUSIONS:The current findings informed development of a social media-based intervention targeting tobacco and alcohol use in young adults. Although there was greater interest in making changes in smoking than drinking behavior, receptivity and acceptability of the Facebook post messages in the STAND intervention was high overall. The intervention is being further refined for evaluation in a larger trial. Trial registration Name of the registry Smoking Tobacco and Drinking Study (STAND); Trial registration number NCT03163303; Date of registration 5/23/17; URL of trial registry record https://clinicaltrials.gov/ct2/show/NCT03163303 .

Dataset Information

Effects of Varenicline Alone and in Combination With Low-dose Naltrexone on Alcohol-primed Smoking in Heavy-drinking Tobacco Users: A Preliminary Laboratory Study.

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