Association between psychosocial factors and co-morbid cigarette smoking and alcohol use in a population experiencing homelessness.

The prevalence of combustible cigarette smoking in populations experiencing homelessness in the United States is five times that of the general population. The psychosocial well-being of persons who smoke and experience homelessness is poorer if such persons also use alcohol heavily. The PTQ2 study was a randomized clinical trial among persons experiencing homelessness who were also current smokers and heavy alcohol consumers. Secondary data analysis of the PTQ2 baseline data was conducted to examine associations among psychosocial variables (anxiety, depression, hopelessness, social network size), heaviness of smoking (cigarettes/day) and alcohol consumption (drinking days/month), and duration and frequency of homelessness. Among the 420 participants, the majority were male (75%), black (70%) and non-Hispanic (94%) with a mean age of 46.6 years (SD = 11.6).  Bivariate analyses show that heaviness of smoking was positively correlated with social network size (r = 0.16, p = .001). Heaviness of drinking was positively correlated with the MINI anxiety score (r = 0.13, p = .009) and marijuana use (median total number of drinks in past 30 days among those who used marijuana in past 30 days vs. did not use: 50 vs. 24, p < .0001), and associated with frequency of homelessness (median total number of drinks in past 30 days among those experiencing homelessness once vs. >1 time: 30 vs. 44, p = .022). The findings highlight the psychosocial factors that warrant consideration when addressing heavy smoking and alcohol consumption in persons experiencing homelessness.

The implementation of a smoking cessation and alcohol abstinence intervention for people experiencing homelessness.

BACKGROUND: In the United States, eighty percent of the adult homeless population smokes cigarettes compared to 15 percent of the general population. In 2017 Power to Quit 2 (PTQ2), a randomized clinical trial, was implemented in two urban homeless shelters in the Upper Midwest to address concurrent smoking cessation and alcohol treatment among people experiencing homelessness. A subset of this study population were interviewed to assess their experiences of study intervention. The objective of this study was to use participants' experiences with the intervention to inform future implementation efforts of combined smoking cessation and alcohol abstinence interventions, guided by the Consolidated Framework for Implementation Research (CFIR). METHODS: Qualitative semi-structured interviews were conducted with 40 PTQ2 participants between 2016-2017 and analyzed in 2019. Interviews were audio-recorded, transcribed, and analyzed using a socially constructivist approach to grounded theory. RESULTS: Participants described the PTQ2 intervention in positive terms. Participants valued the opportunity to obtain both counseling and nicotine-replacement therapy products (intervention characteristics) and described forming a bond with the PTQ2 staff and reliance on them for emotional support and encouragement (characteristics of individuals). However, the culture of alcohol use and cigarette smoking around the shelter environment presented a serious challenge (outer setting). The study setting and the multiple competing needs of participants were reported as the most challenging barriers to implementation (implementation process). CONCLUSION: There are unique challenges in addressing smoking cessation with people experiencing homelessness. For those in shelters there can be the difficulty of pro-smoking norms in and around the shelter itself. Considering pairing cessation with policy level interventions targeting smoke-free spaces, or pairing cessation with housing support efforts may be worthwhile.. Participants described a discord in their personal goals of reduction compared with the study goals of complete abstinence, which may pose a challenge to the ways in which success is defined for people experiencing homelessness. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01932996 , registered 08/30/2013.

Correspondence Between Retrospective and Momentary Self-Reported Posttraumatic Stress Disorder Symptoms: Evidence for Peak and End Effects in Veterans.

Validated retrospective self-report symptom rating scales are recommended for posttraumatic stress disorder (PTSD) screening and treatment. However, such reports may be affected by a respondent's most intense ("peak") or most recent ("end") symptoms. The present study evaluated the correspondence between PTSD symptoms assessed using a standard past-month retrospective rating scale and recorded by ecological momentary assessment (EMA) over the same period and tested hypotheses that retrospective scores would be predicted by peak and end-period momentary symptoms. Male U.S. veterans (N = 35) who served post-9/11 completed the PTSD Symptom Checklist for DSM-5 (PCL-5) at baseline and 1 month later. For 28 days during the intervening period, they received quasi-randomly timed text prompts to complete a modified version of the PCL-5 at that moment. Using multiple regression modeling, controlling for the number of completed EMAs and time (days) since the last EMA, we assessed the predictability of follow-up retrospective PCL-5 scores by (a) the mean of all momentary scores and (b) peak and last-day momentary scores. Retrospective PCL-5 scores were closest to peak scores, d = -0.31, and substantially higher than overall mean, d = 0.99, and last-day momentary scores, d = 0.94. In the regression model, peak symptom experiences and last-day momentary symptoms uniquely predicted follow-up PCL-5 scores over and above significant prediction by overall mean momentary symptom scores. In sum, participants' self-reported past-month PTSD symptom severity did not simply reflect an average over time. Additional questioning is needed to understand peak and recent symptom periods reflected in these estimates.

Ecological momentary assessment of sleep and PTSD symptoms in a veteran sample.

OBJECTIVE: Disturbed sleep is common among individuals with posttraumatic stress disorder (PTSD), but there has been limited research on the momentary relationships between daytime PTSD symptoms and nighttime sleep. The goal of this study was to examine the relationships between daytime peak PTSD symptoms and sleep duration that night and between sleep duration and peak PTSD symptoms the next day. METHOD: The study sample was 42 American post-2001 veterans recruited for a study of risky sexual behavior who completed a baseline PTSD Checklist-5 For 28 days, PTSD symptoms were assessed 3 times per day using a version of the PTSD Checklist-5 modified to ask about the previous 2 hours. Each morning, participants rated the previous night's sleep duration. Two multilevel models were estimated, 1 modeling a given day's peak PTSD symptoms and the other modeling a given night's sleep duration. RESULTS: In the first model, peak PTSD symptoms on a given day were significantly related to mean peak daily PTSD symptoms, estimate = 1.003, p < .001; previous night's sleep duration, estimate = -1.799, p < .001; and previous day's peak PTSD symptoms, estimate = .159, p < .05. In the second model, sleep duration on a given night was associated with mean sleep duration, estimate = 1.032, p < .001, but not with peak PTSD symptoms during that day, estimate = -.001, ns. CONCLUSIONS: This study adds to research indicating that a poorer-than-usual night's sleep is associated with higher peak PTSD symptoms the next day but higher peak PTSD symptoms in the day are not associated with worse sleep that night. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

"It's a hard thing to manage when you're homeless": the impact of the social environment on smoking cessation for smokers experiencing homelessness.

BACKGROUND: Up to 80% of the adult homeless population use tobacco, and smoking cessation programs could offer an important opportunity to address preventable mortality and morbidity for this population. This population faces serious challenges to smoking cessation, including the impact of the social environment. METHODS: Forty participants (11 female; 29 male) from an ongoing smoking cessation randomized clinical trial conducted at 2 urban homeless shelters in the Upper Midwest were invited to take part in semi-structured interviews in 2016-2017. An interviewer used a semi-structured interview guide asking participants to describe their experience of how the social environment impacted their attempt to quit smoking. RESULTS: Participants described feeling pressure to smoke and drink in and around shelters, and that this pressure had led some to start smoking or resume smoking, along with making it very challenging to quit. Participants described being motivated to quit, and seeing smoking cessation as positively impacting the time and focus they felt they had for finding housing. However many felt more interested in reducing their smoking, rather than quitting. CONCLUSIONS: Addressing smoking cessation for people experiencing homelessness is both an important public health opportunity, and a challenge. There is a need to consider cessation in the context of the social and environmental factors impacting smokers who are experiencing homelessness. In particular, there is a need to address the collective value placed on smoking in social interactions. Despite these challenges, there are high levels of motivation and interest in addressing smoking. TRIAL REGISTRATION: NCT01932996 . Date of registration 30th August 2013. Prospectively registered.

Impulsivity interacts with momentary PTSD symptom worsening to predict alcohol use in male veterans.

BACKGROUND: Posttraumatic stress disorder (PTSD) is prevalent among veterans who served post-9/11, and co-occurs with problem alcohol and substance use. Studies using ecological momentary assessment have examined the temporal association between time-varying PTSD symptoms and alcohol use. Results suggest individual differences in these associations. OBJECTIVES: We tested hypotheses that alcohol use measured by momentary assessment would be explained by acute increases in PTSD symptoms, and the PTSD-alcohol association would be moderated by trait impulsivity. METHODS: A sample of 28 male post-9/11-era veterans who reported past-month PTSD symptoms and risky alcohol use were enrolled. On a quasi-random schedule, participants completed three electronic assessments daily for 28 days measuring past 2-h PTSD symptoms, alcohol, and substance use. At baseline, trait impulsivity was measured by the Barratt Impulsiveness Scale. Past-month PTSD symptoms and alcohol use were measured. Using three-level hierarchical models, number of drinks recorded by momentary assessment was modeled as a function of change in PTSD symptoms since last assessment, controlling for lag-1 alcohol and substance use and other covariates. A cross-level interaction tested moderation of the within-time PTSD-alcohol association by impulsivity. RESULTS: A total of 1,522 assessments were completed. A positive within-time association between PTSD symptom change and number of drinks was demonstrated. The association was significantly moderated by impulsivity. CONCLUSION: Results provide preliminary support for a unique temporal relationship between acute PTSD symptom change and alcohol use among veterans with trait impulsiveness. If replicated in a clinical sample, results may have implications for a targeted momentary intervention.

Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned.

There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT00786149 . Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996 . Registered on 20 November 2014.

A Randomized Trial of Contingency Management for Smoking Cessation During Intensive Outpatient Alcohol Treatment.

INTRODUCTION: This randomized clinical trial was designed to evaluate the efficacy of contingency management (CM) for smoking cessation for smokers with alcohol abuse or dependence delivered concurrently with intensive outpatient alcohol treatment. The study also explored the indirect effects of CM smoking treatment and smoking cessation on alcohol and drug use outcomes. METHODS: Alcohol abuse/dependent smokers were randomized to cognitive behavioral therapy plus nicotine replacement therapy plus contingency management (CBT+NRT+CM) or to cognitive behavior therapy plus nicotine replacement therapy (CBT+NRT) delivered concurrent with a three-week intensive outpatient alcohol treatment program. RESULTS: Participants in the CBT+NRT+CM condition were significantly more likely to be cigarette abstinent at the end of treatment (χ2(1)=8.48, p=.004) with approximately double the carbon monoxide confirmed quit rate (60%) compared with the CBT+NRT condition (29%). At the one-month and six-month time-points there were nonsignificant differences in smoking abstinence outcomes by condition. Smoking treatment condition did not directly affect alcohol abstinence outcomes, but we observed an indirect effect of smoking treatment on alcohol and drug abstinence at one-month follow-up that was mediated by smoking cessation at the end of treatment. CONCLUSIONS: Adding CM to an evidence-based smoking cessation treatment that included medication and behavioral counseling doubled the quit rate at the end of treatment. This finding provides strong evidence for the efficacy of CM for helping alcohol dependent smokers reach the milestone of initial smoking abstinence.

Momentary assessment of PTSD symptoms and sexual risk behavior in male OEF/OIF/OND Veterans.

BACKGROUND: Post-traumatic stress disorder (PTSD) in Veterans is associated with increased sexual risk behaviors, but the nature of this association is not well understood. Typical PTSD measurement deriving a summary estimate of symptom severity over a period of time precludes inferences about symptom variability, and whether momentary changes in symptom severity predict risk behavior. METHODS: We assessed the feasibility of measuring daily PTSD symptoms, substance use, and high-risk sexual behavior in Veterans using ecological momentary assessment (EMA). Feasibility indicators were survey completion, PTSD symptom variability, and variability in rates of substance use and sexual risk behavior. Nine male Veterans completed web-based questionnaires by cell phone three times per day for 28 days. RESULTS: Median within-day survey completion rates maintained near 90%, and PTSD symptoms showed high within-person variability, ranging up to 59 points on the 80-point scale. Six Veterans reported alcohol or substance use, and substance users reported use of more than one drug. Eight Veterans reported 1 to 28 high-risk sexual events. Heightened PTSD-related negative affect and externalizing behaviors preceded high-risk sexual events. Greater PTSD symptom instability was associated with having multiple sexual partners in the 28-day period. LIMITATIONS: These results are preliminary, given this small sample size, and multiple comparisons, and should be verified with larger Veteran samples. CONCLUSIONS: Results support the feasibility and utility of using of EMA to better understand the relationship between PTSD symptoms and sexual risk behavior in Veterans. Specific antecedent-risk behavior patterns provide promise for focused clinical interventions.

Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial.

BACKGROUND: Despite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use. METHODS/DESIGN: Participants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52. DISCUSSION: This study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.

Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk.

OBJECTIVE: The aim of this study was to compare the effects of alcohol treatment along with concurrent smoking treatment or delayed smoking treatment on process measures related to alcohol relapse risk. METHOD: Alcohol dependent smokers (N = 151) who were enrolled in an intensive outpatient alcohol treatment program and were interested in smoking cessation were randomized to a concurrent smoking cessation (CSC) intervention or to a waiting list for delayed smoking cessation (DSC) intervention scheduled to begin 3 months later. Daily assessments of relapse process measures were obtained using an Interactive Voice Response (IVR) system for 12 weeks after the onset of smoking treatment in the CSC condition, and before beginning smoking treatment in the DSC condition. Smoking outcomes were assessed at 2 and 13 weeks after starting treatment. RESULTS: Seven-day carbon monoxide (CO) verified smoking abstinence in the CSC condition was 50.5% at 2 weeks and 19.0% at 13 weeks compared with 2.2% abstinence at 2 weeks and 0% abstinence at 13 weeks for those in the DSC condition. Drinking outcomes were not significantly different for CSC versus DSC treatment conditions. On daily IVR assessments, CSC participants had significantly lower positive alcohol outcome expectancies relative to DSC participants. Multilevel modeling (MLM) analyses of within-person effects across the 12 weeks of daily monitoring showed that daily smoking abstinence was significantly associated with same day reports of lower alcohol consumption, lower urge to drink, lower negative affect, lower positive alcohol outcome expectancies, greater alcohol abstinence self-efficacy, greater alcohol abstinence readiness to change, and greater perceived self-control demands. CONCLUSIONS: Analyses of process measures provide support for recommending smoking intervention concurrent with intensive outpatient alcohol treatment. (PsycINFO Database Record

Prospective analysis of early lapse to drinking and smoking among individuals in concurrent alcohol and tobacco treatment.

The aims of the current study were to examine, prospectively, (a) dynamic changes in affective state, self-efficacy, and urge in the hours before initial smoking and drinking lapses among individuals in concurrent alcohol and smoking treatment, and (b) the extent to which self-efficacy, urge to use, and/or the use of one substance predicted lapse to the other substance. Ninety-six men and women recruited for a clinical trial of concurrent alcohol and tobacco treatment were eligible for inclusion. Only data from those who experienced an initial lapse to drinking (n=29) or smoking (n=32) were included. Two outpatient substance abuse clinics provided concurrent alcohol and smoking treatment on a weekly basis for three months. Ecological Momentary Assessment (EMA) methods were employed over a 28-day monitoring period to assess antecedents to first drink, and a 14-day monitoring period was examined for initial smoking lapses. Baseline and EMA measures of positive and negative affect, alcohol/smoking urge, alcohol/smoking abstinence self-efficacy, nicotine withdrawal, and quantity/frequency of alcohol and tobacco use were examined as lapse predictors. Analyses of EMA ratings controlled for the corresponding baseline measure. Smoking lapse among individuals in concurrent alcohol and tobacco treatment was foreshadowed by higher urges to smoke, lower positive mood, and lower confidence to resist smoking. Drinking lapse was preceded by lower confidence to resist smoking, but only among individuals who reported recent smoking. Concurrent alcohol and smoking treatment should focus on the enhancement of abstinence self-efficacy, positive mood, and the curbing of urges in order to offset lapse risk.

Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum.

AIMS: The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes. DESIGN: Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment. SETTING: Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions. PARTICIPANTS: Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day. INTERVENTION: All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions. FINDINGS: Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions. CONCLUSIONS: Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation.

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. On the primary outcome--no hazardous drinking (drinking that exceeded weekly or daily limits) during treatment--25 mg and 50 mg Ntx were superior to placebo (each p<0.05). These findings remained after controlling for baseline predictors or smoking abstinence during treatment. Time to remission of hazardous drinking was examined as a secondary outcome with definitions of hazardous drinking based on weekly limits, daily limits and the combination of weekly and daily limits and the results were consistent with the primary findings. In conclusion, the findings suggest that Ntx can reduce the risk of hazardous drinking in smokers who are not seeking or receiving alcohol treatment, providing strong evidence for the pharmacological effects of Ntx on drinking. This effect appears to favour lower doses that may be better tolerated and less expensive than the higher 100-mg dose. Given its efficacy and favourable side-effect profile, the 25-mg dose should be considered for future studies of combination therapy.

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., the Minnesota Nicotine Withdrawal Scale, the Questionnaire on Smoking Urges, and the Center for Epidemiological Studies-Depression) were completed a week after the target quit date. The sample was composed of 378 daily smokers. Moderate to high correlations were found between the research questionnaires obtained at the end of the week and the corresponding daily IVR reports of nicotine withdrawal, craving, and depressive symptoms. However, the sample size decreased on each day of IVR reporting due to attrition. Thus, an appealing aspect of daily assessment using an IVR system is that it can provide additional data that are not obtained with paper and pencil assessments given once per week, but it will be important for future studies to concentrate on improving adherence with the IVR system in this population.

Concurrent brief versus intensive smoking intervention during alcohol dependence treatment.

Alcohol dependent smokers (N=118) enrolled in an intensive outpatient substance abuse treatment program were randomized to a concurrent brief or intensive smoking cessation intervention. Brief treatment consisted of a 15-min counseling session with 5 min of follow-up. Intensive intervention consisted of three 1-hr counseling sessions plus 8 weeks of nicotine patch therapy. The cigarette abstinence rate, verified by breath carbon monoxide, was significantly higher for the intensive treatment group (27.5%) versus the rate for the brief treatment group (6.6%) at 1 month after the quit date but not at 6 months, when abstinence rates fell to 9.1% for the intensive treatment group and 2.1% for the brief treatment group. Smoking treatment assignment did not significantly impact alcohol outcomes. Although intensive smoking treatment was associated with higher rates of short-term tobacco abstinence, other, perhaps more intensive, smoking interventions are needed to produce lasting smoking cessation in alcohol dependent smokers.

Alcohol and tobacco cessation in alcohol-dependent smokers: analysis of real-time reports.

Alcohol-tobacco interactions and relapse precipitants were examined among alcohol-dependent smokers in a trial of concurrent alcohol and tobacco treatment. After discharge from treatment, participants completed 14 days of electronic diary (ED) assessments of mood, self-efficacy, urges to drink or smoke, and drinking and smoking behavior. ED data revealed an increase in frequency of alcohol urges after smoking episodes. Drinking relapse episodes were predicted by prior ED ratings of low self-efficacy to resist drinking and high urge to smoke. Smoking relapse episodes were predicted by high urge to smoke and high negative, high arousal mood. Results support a cross-substance cue reactivity model of multiple substance use and a limited-strength model, but not a cross-substance coping model.

A controlled trial of naltrexone augmentation of nicotine replacement therapy for smoking cessation.

BACKGROUND: Many smokers remain refractory to current therapies, which only partially address weight gain after smoking cessation. Thus, this study evaluated whether naltrexone hydrochloride augmentation of nicotine patch therapy improves smoking abstinence and reduces postcessation weight gain more than nicotine patch therapy alone and at what dose. METHODS: Six-week double-blind placebo-controlled trial with follow-up in an outpatient research center. Four hundred individuals who smoked 20 or more cigarettes daily were randomly assigned to treatment for 6 weeks with a 21-mg nicotine patch and oral naltrexone hydrochloride (0, 25, 50, or 100 mg/d) after equal random treatment assignment and followed up for 1 year after randomization. The a priori specified primary end points were prolonged 4-week cigarette abstinence after a 2-week grace period in the intent-to-treat sample and weight gain in these abstainers. RESULTS: We found no significant differences in prolonged 4-week abstinence (P = .49) or 6-week continuous abstinence after the quit date (P = .12) during treatment in the intent-to-treat analysis. Among 295 treatment completers, the 100-mg dose was associated with higher continuous abstinence rates (71.6%) compared with placebo (48%) (odds ratio, 2.73; 95% confidence interval, 1.39-5.39; P<.01). Among continuous abstainers, the 25-mg naltrexone hydrochloride group gained significantly less weight (mean +/- SEM, 0.7 +/- 0.31 kg) than the placebo group (mean +/- SEM, 1.9 +/- 0.33 kg; P<.01). Similar naltrexone dose effects on weight were found for those with prolonged abstinence and treatment completers, irrespective of abstinence. CONCLUSIONS: The 100-mg dose of naltrexone hydrochloride appears the most promising for augmenting the efficacy of the nicotine patch on smoking cessation outcomes but requires further study. The significant weight reduction with low-dose naltrexone therapy suggests that it may be useful as a second-line treatment for weight-concerned smokers.

Correspondence between Interactive Voice Response (IVR) and Timeline Followback (TLFB) reports of drinking behavior.

This study compared reports of alcohol consumption using an Interactive Voice Response (IVR) system and the Timeline Followback (TLFB). One hundred eighty-two daily smokers who were not alcohol dependent provided once daily reports of alcohol consumption using an IVR system and participated in a weekly TLFB interview. The reporting time period was 7 days after participants attempted to quit smoking as part of participation in a smoking cessation clinical trial. The results revealed moderate to high correlations between reports of drinking behavior as assessed by IVR and TLFB. Reporting biases for both IVR and TLFB were approximately equal, with a slight trend toward underreporting drinking on the TLFB. Compliance with the IVR system was poor. This study provides preliminary evidence that it is possible to use an IVR system for the assessment of alcohol use in smokers participating in a clinical trial, and IVR seems to adequately assess drinking behavior in those that use the system. However, future studies should focus on improving compliance with IVR in this population.

Do daily interactive voice response reports of smoking behavior correspond with retrospective reports?

This study focuses on comparing reports of cigarette consumption using an interactive voice response (IVR) system and the timeline follow-back (TLFB) method. As part of a smoking cessation trial, daily reports of cigarette use were collected using an IVR system and TLFB for 7 days after participants attempted to quit smoking. Reports of cigarette consumption were assessed for the entire sample (N = 381) and for the subset of nonabstinent participants (n = 129 smokers). The results revealed high correlations between reports of smoking behavior, as assessed by IVR and TLFB. Compliance with the TLFB was superior to compliance with the IVR system. This problem should be addressed if researchers wish to use an IVR system in future smoking cessation clinical trials.