Risk factors for treatment failure in smokers: relationship to alcohol use and to lifetime history of an alcohol use disorder.

Little is known about the impact of alcohol involvement on smoking cessation relapse or possible mechanisms for these associations. We addressed these issues using data from a randomized clinical trial of two types of framed messages (gain vs. loss) in conjunction with open label sustained-release (SR) bupropion (Toll et al.

Do patients with alcohol dependence respond to placebo? Results from the COMBINE Study.

Objective: The purpose of this study was to examine the nature of the effect of placebo medication plus accompanying medical management in the treatment of alcohol dependence.

Method: The National Institute on Alcohol Abuse and Alcoholism COMBINE (Combining Medications and Behavioral Interventions) study, a randomized controlled double-blind trial of 1,383 alcohol-dependent patients, compared combinations of medications (acamprosate [Campral] and naltrexone [ReVia]) and behavioral therapy (medical management and specialist-delivered behavioral therapy) for alcohol dependence. This report focuses on a subset of that study population (n = 466) receiving (1) specialized behavioral therapy alone (without pills), (2) specialized behavioral therapy + placebo medication + medical management, or (3) placebo + medical management.

Nicotine dependence and psychiatric and substance use comorbidities in a sample of American Indian male veterans.

Background: American Indians and Alaska Natives have the highest rates of nicotine dependence in the U.S. However, studies analyzing associations between nicotine dependence and psychiatric and substance use disorders in these groups have been limited.

Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation.

The opiate antagonist naltrexone (Ntx) has demonstrated efficacy in the treatment of alcohol dependence and as a component of treatment to reduce heavy drinking. At present, there are no published dose-ranging clinical trials of the oral preparation for treatment of problem drinking. The present study evaluated the effects of Ntx on alcohol use among the subset of hazardous drinkers (n=102) who participated in a placebo-controlled, dose-ranging trial of oral Ntx (25-mg, 50-mg and 100-mg doses) combined with open-label transdermal nicotine patch for enhancing smoking cessation.

Treatment implications: using neuroscience to guide the development of new pharmacotherapies for alcoholism.

Developing pharmacotherapies to treat alcohol dependence and associated health problems traditionally has been based on gaining a better understanding of the neuroscience underlying alcohol-drinking behavior. To date, three medications have been approved for the treatment of alcohol dependence: disulfiram (Antabuse®), naltrexone (Revia®, Vivitrol®, and Naltrel®), and acamprosate (Campral®). However, these medications have modest efficacy, and there is a great need for newer medications that target different neurochemical systems and which could be used either as adjunctive treatments or to treat subpopulations of drinkers.

A brief 7-day estimate of alcohol consumption for use in smoking cessation clinical trials.

Accruing evidence of an association between drinking and smoking relapse suggests that it is important to measure alcohol use in smoking cessation studies. However, most studies do not do so, often because of the extra time burden required for these assessments. Data from participants (N=634) in two smoking cessation clinical trials were used to examine the relationship between short and longer periods of monitoring for a number of Timeline Followback (TLFB) drinking metrics at baseline and during treatment.

Comparison of expired carbon monoxide and plasma cotinine as markers of cigarette abstinence.

The clinical pharmacology of biochemical measures of nicotine exposure has been thoroughly reviewed with regard to usefulness and limitations in detecting abstinence from cigarette smoking. While plasma nicotine concentration measures only acute nicotine exposure, plasma, salivary, and urine cotinine concentrations reflect exposure over an extended period of time. Although, expired carbon monoxide (CO) is frequently used to confirm self reports, it has a relatively short half life, calling into question whether this measure might provide misleading information by exaggerating smoking cessation success rates.

A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

Introduction: Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

Correspondence of Interactive Voice Response (IVR) reports of nicotine withdrawal, craving, and negative mood with questionnaire ratings.

This study focuses on comparing reports of nicotine withdrawal, craving, and depressive symptoms obtained using an Interactive Voice Response (IVR) system and several questionnaires. As part of a smoking cessation trial, daily reports of withdrawal, craving, and negative mood were collected using an IVR system for 7 days after participants attempted to quit smoking, and several pencil and paper questionnaires (i.e.

Improvement of physical health and quality of life of alcohol-dependent individuals with topiramate treatment: US multisite randomized controlled trial.

Background: Topiramate can improve drinking outcomes via a hypothesized mechanism of facilitating gamma-aminobutyric acid function and inhibiting glutaminergic pathways in the corticomesolimbic system. We sought to determine whether topiramate's antidrinking effects are bolstered by improvements in physical and psychosocial well-being.

Methods: In a 17-site, 14-week, double-blind, randomized controlled trial, we compared the effects of topiramate (up to 300 mg/d) vs placebo on physical health, obsessional thoughts and compulsions about using alcohol, and psychosocial well-being among 371 alcohol-dependent subjects who received weekly adherence enhancement therapy.

A pilot study of naltrexone and BASICS for heavy drinking young adults.

Heavy drinking young adults often have limited motivation to change their drinking behavior. Adding pharmacotherapy to brief counseling is a novel approach to treating this population. A small open-label pilot study was conducted to assess the feasibility of offering eight weeks of daily and targeted (i.

Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial.

Background: Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed. The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural settings. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene (OPRM1) predicted response to naltrexone, as had been reported in Caucasians.

An evaluation of mu-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study.

Context: Naltrexone hydrochloride treatment for alcohol dependence works for some individuals but not for everyone. Asn40Asp, a functional polymorphism of the mu-opioid receptor gene (OPRM1), might predict naltrexone response.

Objective: To evaluate whether individuals with alcoholism who are heterozygous (Asp40/Asn40) or homozygous (Asp40/Asp40) for the OPRM1 Asp40 allele respond better to naltrexone.

Message framing for smoking cessation: the interaction of risk perceptions and gender.

Because quitting smoking is clearly linked to preventing health problems such as lung cancer, research on health message framing based on prospect theory suggests that gain-framed messages (i.e., emphasizing the benefits of quitting smoking) would be more persuasive in promoting cessation than loss-framed messages (i.

Comparing gain- and loss-framed messages for smoking cessation with sustained-release bupropion: a randomized controlled trial.

Prospect theory suggests that because smoking cessation is a prevention behavior with a fairly certain outcome, gain-framed messages will be more persuasive than loss-framed messages when attempting to encourage smoking cessation. To test this hypothesis, the authors randomly assigned participants (N=258) in a clinical trial to either a gain- or loss-framed condition, in which they received factually equivalent video and printed messages encouraging smoking cessation that emphasized either the benefits of quitting (gains) or the costs of continuing to smoke (losses), respectively. All participants received open label sustained-release bupropion (300 mg/day) for 7 weeks.

Topiramate for treating alcohol dependence: a randomized controlled trial.

Context: Hypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitation of gamma-aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system.

Objective: To determine if topiramate is a safe and efficacious treatment for alcohol dependence.

Design, Setting, And Participants: Double-blind, randomized, placebo-controlled, 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence, conducted between January 27, 2004, and August 4, 2006, at 17 US sites.

Effect of transdermal nicotine replacement on alcohol responses and alcohol self-administration.

Rationale: Nicotine replacement is commonly used to treat tobacco use in heavy-drinking smokers. However, few studies have examined the effect of nicotine replacement on subjective and physiological responses to alcohol and alcohol drinking behavior.

Objective: The primary aim of this within-subject, double-blind study was to examine whether transdermal nicotine replacement (0 mg vs 21 mg/day) altered response to a low-dose priming drink and subsequent ad libitum drinking behavior.

Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment.

Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation that is Food and Drug Administration-approved for the treatment of alcohol dependence in patients able to abstain from alcohol before treatment initiation. This paper presents the results of an analysis of efficacy data from a subgroup of patients with 4 days or more of voluntary abstinence before treatment initiation (n = 82) on a wide range of drinking-related outcomes. In these patients, all of whom received counseling, the rate of abstinence was severalfold higher for XR-NTX 380 mg compared with placebo: median time to first drink was 41 days versus 12 days, respectively; rate of continuous abstinence at end of the study was 32% versus 11% (P = 0.

123I-5-IA-85380 SPECT imaging of nicotinic acetylcholine receptor availability in nonsmokers: effects of sex and menstrual phase.

Unlabelled: The study of the effects of sex and hormones on brain chemistry and neurotransmission is of increasing importance as evidence emerges of sex differences in behavioral symptoms and treatment response in neuropsychiatric disorders. The nicotinic acetylcholine receptor (nAChR) system has been implicated in a variety of psychiatric disorders, including tobacco smoking, for which there is strong evidence supporting sex differences in behaviors and response to smoking cessation treatments. We examined the availability of nAChR containing the beta(2) subunit in healthy men and women and the influence of menstrual phase among women.

Timing and predictors of postpartum return to smoking in a group of inner-city women: an exploratory pilot study.

Background: Approximately 40 percent of women smokers will stop smoking cigarettes during pregnancy; however, 70 percent of those who stop will resume smoking by 6 months postpartum. This exploratory pilot study prospectively examined the timing and predictors of returning to smoking after pregnancy in a group of inner-city women who stopped smoking cigarettes during pregnancy.

Methods: We interviewed women who stopped smoking just before or during their pregnancies during their postpartum hospital stay and at their infants' 2-week health supervision visits.

Translational research in medication development for nicotine dependence.

A major obstacle to the development of medications for nicotine dependence is the lack of animal and human laboratory models with sufficient predictive clinical validity to support the translation of knowledge from laboratory studies to clinical research. This Review describes the animal and human laboratory paradigms commonly used to investigate the pathophysiology of nicotine dependence, and proposes how their predictive validity might be determined and improved, thereby enhancing the development of new medications.

A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain.

Certain barriers prevent some cigarette smokers from attempting to quit, particularly the fear of post-cessation weight gain. This investigation was an open label study of naltrexone hydrochloride (25 mg/day) in combination with sustained-release (SR) bupropion hydrochloride (300 mg/day) for smoking cessation and minimization of post-quit weight gain in weight-concerned smokers. The study sample (n=20) was compared to matched controls (n=20) who received an identical psychosocial intervention and bupropion SR treatment regimen.

Validation of a scale for the assessment of food cravings among smokers.

Weight gain associated with smoking cessation impedes attempts to quit smoking and may lead to obesity. One factor that might contribute to weight gain is cravings for sweet or rich foods. To date, no reliable measure exists for evaluating these cravings.

Enhancing brief cognitive-behavioral therapy with motivational enhancement techniques in cocaine users.

Background: We investigated the impact of enhancing brief cognitive-behavioral therapy with motivational interviewing techniques for cocaine abuse or dependence, using a focused intervention paradigm.

Methods: Participants (n=74) who met current criteria for cocaine abuse or dependence were randomized to three-session cognitive-behavioral therapy (CBT) or three-session enhanced CBT (MET+CBT), which included an initial session of motivational enhancement therapy (MET). Outcome measures included treatment retention, process measures (e.

Confirmatory factor analysis of the Minnesota Nicotine Withdrawal Scale.

The authors examined the factor structure of the Minnesota Nicotine Withdrawal Scale (MNWS) using confirmatory factor analysis in 3 clinical research samples of smokers trying to quit (N = 723). Three confirmatory factor analytic models, based on previous research, were tested with each of the 3 study samples at multiple points in time. A unidimensional model including all 8 MNWS items was found to be the best explanation of the data.