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Effects of the opioid receptor antagonist naltrexone on smoking and related behaviors in smokers preparing to quit: a randomized controlled trial.

ABSTRACT: To determine if naltrexone affects smoking behaviors in smokers preparing to quit, and whether or not such pre-quit responses predict post-quit date outcomes.Double-blind, placebo-controlled, randomized study. The current study focused on smoking-related outcomes in the pre-quit phase, which was 1 week prior to the quit date, and these findings were linked with reductions in the same outcomes demonstrated in the post-quit phase published previously for this randomized controlled trial (RCT) in mediation analyses.Community sample of adult smokers desiring to quit in Chicago, Illinois, USA.Participants were 315 smokers randomized to naltrexone (n = 161; mean age = 42.58 years; 60% Caucasian) or placebo (n = 154; mean age = 41.32 years; 55% Caucasian).The difference from baseline in the number of cigarettes smoked during the pre-quit phase interval was the primary outcome. Secondary pre-quit outcomes were assessed using Likert scales of subjective responses and consumption of cigarettes, alcohol and food. Number of cigarettes smoked, alcoholic drinks consumed and the Brief Questionnaire of Smoking Urges were assessed in the post-quit phase.Relative to placebo, naltrexone decreased the number of cigarettes smoked (-4.21 versus -2.93, P < 0.05), smoking urge (P = 0.02) and number of alcoholic drinks consumed (P = 0.04). Exploratory mediation analyses linking outcomes of the pre-quit and post-quit phases found that naltrexone's effects on reducing smoking urge, cigarettes smoked and alcoholic drinks consumed in the pre-quit phase demonstrated full mediation of their respective effects during the post-quit phase.Naltrexone taken in the week before a quit attempt reduces cigarette consumption, urges to smoke and alcohol consumption relative to placebo. The size of the effect mediates statistically the size of similar effects after the quit date.

SUBMITTER: King A

PROVIDER: S-EPMC3775903 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Effects of the opioid receptor antagonist naltrexone on smoking and related behaviors in smokers preparing to quit: a randomized controlled trial.

King Andrea A Cao Dingcai D Zhang Lingjiao L Rueger Sandra Yu SY

Addiction (Abingdon, England) 20130712 10

<h4>Aims</h4>To determine if naltrexone affects smoking behaviors in smokers preparing to quit, and whether or not such pre-quit responses predict post-quit date outcomes.<h4>Design</h4>Double-blind, placebo-controlled, randomized study. The current study focused on smoking-related outcomes in the pre-quit phase, which was 1 week prior to the quit date, and these findings were linked with reductions in the same outcomes demonstrated in the post-quit phase published previously for this randomized ...[more]

PMID: 23714324

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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:Supratherapeutic doses of methylphenidate activate μ-opioid receptors, which are linked to euphoria. This study assessed whether naltrexone, a mixed μ-opioid antagonist, may attenuate the euphoric effects of stimulants, thereby minimizing their abuse potential in subjects with attention-deficit/hyperactivity disorder (ADHD). We conducted a 6-week, double-blind, placebo-controlled, randomized clinical trial of naltrexone in adults with DSM-IV ADHD receiving open treatment with a long-acting formulation of methylphenidate (January 2013 to June 2015). Spheroidal Oral Drug Absorption System methylphenidate (SODAS-MPH) was administered twice daily, was titrated to ~1 mg/kg/d over 3 weeks, and was continued for 3 additional weeks depending on response and adverse effects. Subjects were adults with ADHD preselected for having experienced euphoria with an oral test dose of 60 mg of immediate-release methylphenidate (IR-MPH). The primary outcome measure was Question 2 (Liking a Drug Effect) on the Drug Rating Questionnaire, Subject version, which was assessed after oral test doses of 60 mg of IR-MPH were administered after the third and sixth weeks of treatment with SODAS-MPH. Thirty-seven subjects who experienced stimulant-induced (mild) euphoria at a baseline visit were started in the open trial of SODAS-MPH and randomized to naltrexone 50 mg/d or placebo. Thirty-one subjects completed through week 3, and 25 completed through week 6. Naltrexone significantly diminished the euphoric effect of IR-MPH during the heightened-risk titration phase (primary outcome; first 3 weeks) (χ² = 5.07, P = .02) but not the maintenance phase (weeks 4-6) (χ² = 0.22, P = .64) of SODAS-MPH treatment. Preclinical findings are extended to humans showing that naltrexone may mitigate stimulant-associated euphoria. Our findings provide support for further studies combining opioid receptor antagonists with stimulants to reduce abuse potential. ClinicalTrials.gov identifier: NCT01673594.

Project description:BackgroundAutomatic processes to approach smoking-related cues have been repeatedly linked to smoking status, intensity of smoking, and cigarette craving. Moreover, recent findings suggest that targeting those tendencies directly by means of approach bias modification (ABM) has merit in changing maladaptive approach tendencies for drug cues and reducing drug consumption. However, training effects tend to be small. Embedding the training into virtual reality (VR) technology could be a promising way to improve training efficacy. The present protocol describes a randomized controlled trial that aims to assess the efficacy of a newly developed VR-ABM as a means of reducing smoking-related approach biases or nicotine consumption in smokers seeking abstinence.MethodsOne hundred daily smokers who are motivated to quit smoking will be recruited into the randomized controlled trial. All participants will attend a brief smoking cessation intervention (TAU) and will be randomly assigned either to the experimental (VR-avoidance training) or the placebo-control group (VR-placebo training). During the VR-avoidance training, participants are implicitly instructed to make an avoidance movement in response to smoking-related objects (e.g., cigarettes) and an approach movement in response to alternative objects (e.g., healthy food). During the VR-placebo training, no such contingency between arm movement and item content exists. Trainings are administered in six sessions within two weeks. Training effects on automatic approach tendencies and smoking behavior are measured immediately after training and at a 7-week follow-up.DiscussionEmbedding the training into virtual reality (VR) technology could be a promising new way to improve ecological validity, realism, and immersion and thereby increase ABM training effects. The results of this study can inform future research in the optimization and advancement of treatment for addiction.Trial registrationRegistered with Current Controlled Trials: study ID ISRCTN16006023. Registered on 28 March 2019.

Project description:IntroductionMost smoking cessation approaches are modeled on heavy daily smoking. With increasing prevalence of nondaily smoking, it may be necessary to modify these approaches for nondaily smokers.AimsTo provide information about beliefs and attitudes relevant to smoking cessation for nondaily smokers.MethodsSecondary analysis of two prospective studies on young adult smokers (18-24 years of age) provided brief advice to quit smoking. Measures include baseline levels of constructs relevant to smoking cessation counseling and perceived benefits of and barriers to smoking cessation.ResultsParticipants (n = 40 nondaily, 122 daily smokers) were predominantly White (70% and 84%, respectively), gender-balanced (50% and 43% female), full-time college students (89% and 95%). At baseline, nondaily smokers reported lower levels of nicotine dependence (p < .001; nondaily: Fagerström Test for Nicotine Dependence (FTND) = 0.8 ± 1.5, daily: FTND = 3.1 ± 1.9), lower urge to smoke (p < .001), greater self-efficacy when facing external smoking stimuli (p = .03), expecting to experience fewer positive effects (reduced negative affect, p = <.001, stimulation, p = .02), and valuing the importance of smoking effects less (ps < .01) than daily smokers. During counseling, nondaily smokers generated both fewer benefits of cessation (Wald X2(df = 1) = 4.91, p = .027) and fewer barriers (Wald X2(df = 1) = 5.99, p =.014) than daily smokers. Withdrawal was not listed by nondaily smokers as a barrier (p < .01).ConclusionsConstructs relevant to smoking cessation for daily smokers were less salient to young nondaily smokers, compared with moderately addicted young daily smokers, as indicated by responses to standardized scales and by the generation of fewer benefits and barriers in counseling. Interventions may need to find novel ways to engage nondaily smokers, particularly young adult, in smoking cessation efforts.ImplicationsThis study is unique in eliciting benefits and barriers from nondaily smokers as they are about to make a quit attempt. This is a critically important point in time, as this is the point in time in which an action plan is formed and can be informed and enhanced by smoking cessation support. Our study further allowed direct comparison to daily smokers undergoing the same procedures, which allowed the identification of unique factors that may impact nondaily smokers in their quit attempt, which may guide intervention efforts. Use of a mixed method design further strengthen the rigor of this study.

Project description:BackgroundTobacco use is one of the most common preventable causes of death, but more than half of the Chinese men still use tobacco products. Moreover, 63.6% of Chinese smokers have stated that they would not consider quitting. Specialized and intensive smoking-cessation services are too expensive and passive to have major clinical and public health impacts in developing countries like China. Smoking cessation medications are not covered by medical insurance, and their high price prevents Chinese smokers from using them. Brief interventions are needed to provide cost-effective and timesaving tobacco dependence treatments in China mainland.Methods/designWe describe a two-arm randomized controlled trial for smokers who have no intention to quit. The project will be conducted in outpatient clinics at a large hospital in Beijing, China. Both arms include one face-to-face interview plus five follow-up interventions. Each intervention will last approximately one minute. Subjects allocated to the smoking-reduction intervention arm (SRI) will be advised to reduce smoking consumption to at least half of their current consumption level within the next month. All subjects in the SRI will be warned to bear in mind that an attempt to reduce smoking is an intermediate step before complete cessation. Smokers who have successfully reduced their smoking consumption will be encouraged to completely cease smoking. Controls are subjects allocated to the exercise- and diet-advice arm (EDA) and will be given advice about healthy diet and physical activity, but the advice will not include smoking cessation or reduction. Data collection will be done at baseline and at each follow-up interview using standardized questionnaires. The primary outcomes include self-reported and biochemically verified 7-day point prevalence and prolonged abstinence rates at 12-month follow-up.DiscussionWe expect that an intention to quit in smoking outpatients can be motivated by physicians in the clinic setting. If this very brief smoking-reduction intervention can be demonstrated to have a positive impact on long-term smoking cessation, this strategy has the potential to be a viable and acceptable approach and may be used widely in China and elsewhere.Clinical trial registrationClinicalTrials.gov: NCT02370147 (date of registration: 23 th February, 2015).

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Effects of the opioid receptor antagonist naltrexone on smoking and related behaviors in smokers preparing to quit: a randomized controlled trial.

Publications

Effects of the opioid receptor antagonist naltrexone on smoking and related behaviors in smokers preparing to quit: a randomized controlled trial.

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