Smoking outcome by psychiatric history after behavioral and varenicline treatment.
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ABSTRACT:
SUBMITTER: McClure JB
PROVIDER: S-EPMC2860053 | biostudies-literature | 2010 Jun
REPOSITORIES: biostudies-literature
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Smoking outcome by psychiatric history after behavioral and varenicline treatment.
McClure Jennifer B JB Swan Gary E GE Catz Sheryl L SL Jack Lisa L Javitz Harold H McAfee Tim T Deprey Mona M Richards Julie J Zbikowski Susan M SM
Journal of substance abuse treatment 20100402 4
Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (positive psychiatric history [PH+], n = 271) and without (PH-, n = 271) a diagnosis of PH based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder. Everyone received behavioral counseling plus varenicline and was followed for 6 months post quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, p < or = .01) but did not differ in their us ...[more]
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Project description:BackgroundSmoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence.PurposeThis study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline.MethodsCurrent treatment-seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401); proactive telephone-based counseling (PTC; n=402); or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-ups); the number of days varenicline was taken; and treatment-related symptoms. Behavioral measures determined utilization of both the web- and Phone-based counseling.ResultsIntent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC-web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months (OR=1.48, 95% CI=1.12, 1.96), but no between-group differences in abstinence outcomes were seen at 6 months.ConclusionsPhone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.
| S-EPMC2879135 | biostudies-literature
Project description:There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n=401), PTC (n=402), or combined PTC-Web counseling (n=399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.
| S-EPMC3124766 | biostudies-literature
Project description:UnlabelledSchizophrenic patients have a high rate of smoking and cognitive deficits which may be related to a decreased number or responsiveness of nicotinic receptors in their brains. Varenicline is a partial nicotinic agonist which is effective as an antismoking drug in cigarette smokers, although concerns have been raised about potential psychiatric side-effects. We conducted a double-blind placebo controlled study in 87 schizophrenic smokers to evaluate the effects of varenicline (2 mg/day) on measures of smoking, cognition, psychiatric symptoms, and side-effects in schizophrenic patients who were cigarette smokers. Varenicline significantly decreased cotinine levels (P<0.001), and other objective and subjective measures of smoking (P < .01), and responses on a smoking urges scale (P = .02), more than placebo. Varenicline did not improve scores on a cognitive battery designed to test the effect of drugs on cognitive performance in schizophrenia (the MATRICS battery), either in overall MATRICS battery Composite or individual Domain scores, more than placebo. There were no significant differences between varenicline vs. placebo effects on total symptom scores on psychiatric rating scales, PANSS, SANS, or Calgary Depression scales, and there were no significant drug effects in any of these scales sub-scores when we used Benjamin-Hochberg corrected significance levels (? = .05). Varenicline patients did not show greater side-effects than placebo treated patients at any time point when controlled for baseline side-effect scores. Our study supports the use of varenicline as a safe drug for smoking reduction in schizophrenia but not as a cognitive enhancer.Trial registrationClinicalTrials.gov 00802919.
| S-EPMC4701439 | biostudies-literature
Project description:INTRODUCTION:Attention-Deficit/Hyperactivity Disorder (ADHD) is associated with nicotine dependence and difficulty quitting smoking. Few cessation trials specifically consider the impact of ADHD on treatment outcomes, including those testing established pharmacological therapies, such as varenicline. METHODS:The current study focused on the impact of pretreatment ADHD inattention (IN) and hyperactivity-impulsivity (HI) symptoms on treatment outcome in a randomized controlled trial of varenicline [N=205, average age=34.13(10.07), average baseline cigarettes per day=14.71(7.06)]. Given that varenicline's putative therapeutic mechanism is attenuation of withdrawal severity during abstinence, we also tested changes in withdrawal as a mediator of treatment effects in high and low ADHD groups. RESULTS:ADHD symptom severity in this sample was in the subclinical range. Cessation was associated with HI, but not IN, such that high HI individuals on varenicline reported the lowest smoking levels at the end of treatment across all groups (3.06cig/day for high HI vs 4.02cig/day for low HI). Individuals with high HI who received placebo had the highest smoking at the end of treatment (7.69cigs/day for high HI vs 5.56cig/day for low HI). Patterns continued at follow-up. Varenicline significantly reduced withdrawal for those with high HI, but not low HI. However, path models did not support an indirect effect of medication on reducing smoking via withdrawal in either group, suggesting that unmeasured variables are involved in varenicline's effect on reducing smoking. CONCLUSIONS:These data add to a gap in the smoking cessation literature regarding the impact of ADHD symptoms on the efficacy and mechanisms of frontline pharmacological treatments.
| S-EPMC5599352 | biostudies-literature
Project description:ObjectiveThe authors assessed the efficacy and safety of combination treatment with varenicline and sustained-release bupropion for smokers who, based on an assessment of initial smoking reduction prior to the quit date, were deemed unlikely to achieve abstinence using nicotine patch treatment.MethodIn a randomized, double-blind, parallel-group adaptive treatment trial, the authors identified 222 cigarette smokers who failed to show a reduction of more than 50% in smoking after 1 week of nicotine patch treatment. Smokers were randomly assigned to receive 12 weeks of varenicline plus bupropion or varenicline plus placebo. The primary outcome measure was continuous smoking abstinence at weeks 8-11 after the target quit date.ResultsBoth treatments were well tolerated. Participants who received the combination treatment had a significantly higher abstinence rate than those who received varenicline plus placebo (39.8% compared with 25.9%; odds ratio=1.89; 95% CI=1.07, 3.35). Combination treatment had a significantly greater effect on abstinence rate in male smokers (odds ratio=4.26; 95% CI=1.73, 10.49) than in female smokers (odds ratio=0.94; 95% CI=0.43, 2.05). It also had a significantly greater effect in highly nicotine-dependent smokers (odds ratio=3.51, 95% CI=1.64, 7.51) than in smokers with lower levels of dependence (odds ratio=0.71, 95% CI=0.28, 1.80).ConclusionsAmong smokers who did not show a sufficient initial response to prequit nicotine patch treatment, combination treatment with varenicline and bupropion proved more efficacious than varenicline alone for male smokers and for smokers with a high degree of nicotine dependence.
| S-EPMC4557205 | biostudies-literature
Project description:This study replicated and extended results of a previous trial, which found that combination varenicline/bupropion treatment increased smoking abstinence in smokers who were male, highly dependent, and who did not respond to prequit nicotine patch treatment with a >50% reduction in expired-air carbon monoxide in the first week.One hundred and twenty-two male nicotine patch nonresponders and 52 responders were identified. Smokers in each group were randomized to receive 12 weeks of varenicline plus bupropion treatment versus varenicline plus placebo. The primary outcome was continuous smoking abstinence at weeks 8-11 after the target quit date.For smokers with a high level of dependence, judged by having a baseline Fagerstrom Test for Nicotine Dependence (FTND) score ? 6 and cigarette consumption ? 20/d, combination varenicline/bupropion treatment increased the abstinence rate relative to varenicline alone: 71.0% versus 43.8% (odds ratio = 3.14; 95% confidence interval = 1.11-8.92, p [one tailed] = .016). In contrast, less dependent smokers did not show a benefit of combination treatment relative to varenicline (abstinence rates of 32.1% vs. 45.6%, respectively); there was a significant interaction of treatment and dependence level. Patch nonresponders tended to benefit the most from combination treatment, which was well tolerated overall.Combination varenicline/bupropion treatment proved significantly more efficacious than varenicline alone among highly dependent male smokers. These results, together with prior studies, support an adaptive treatment paradigm that assigns smoking cessation treatment according to baseline smoker characteristics and initial response to nicotine patch treatment.This study replicated, in a prospective manner, an important and surprising retrospective finding from a previous clinical trial, which showed that a specific subpopulation of smokers benefited substantially from receiving a combination treatment of varenicline plus bupropion, relative to varenicline plus placebo. Specifically, male smokers having high baseline nicotine dependence (FTND score ? 6 and cigarette consumption ? 20/d), showed a marked increase in smoking abstinence rate on combination pharmacotherapy. The present study likewise found an enhancement in end-of-treatment abstinence rate in this subgroup, from 43.8% to 71.0%. The adaptive treatment paradigm, which classifies smokers based on initial dependence level and response to prequit nicotine patch treatment, may be used to identify target populations of smokers whose success can be enhanced by intervening with combination pharmacotherapy before the quit-smoking date.ClinicalTrials.gov identifier: NCT01806779.
| S-EPMC5896474 | biostudies-literature
Project description:Neuronal nicotinic acetylcholine receptors (nAChRs) are a key target in medication development for various neuropsychiatric disorders, including nicotine dependence. Varenicline, a partial agonist at the alpha4beta2 nAChRs, is a new, efficacious medication for nicotine dependence. Its effects on the affective and cognitive dimensions of nicotine withdrawal have yet to be well characterized.Sixty-seven treatment-seeking smokers were administered varenicline (x 21 days) and placebo (x 21 days) in a double-blind within-subject crossover design. Following medication run-up (Days 1-10), there was a 3-day mandatory smoking abstinence phase (Days 11-13) during which subjective symptoms and cognitive performance were assessed. Participants were reexposed to a scheduled smoking lapse (Day 14) and followed for days to lapse (Days 15-21) in each medication period.In the varenicline period, compared with placebo, withdrawal symptoms (p = .04), smoking urges (p < .001), and negative affect (p = .01) during manditory abstinence were significantly lower, and levels of positive affect (p = .046), sustained attention (p = .018), and working memory (p = .001) were significantly greater. Varenicline also significantly reduced subjective rewarding effects of the scheduled smoking lapse (e.g., satisfaction, relief, liking; p = .003). Medication effects on days to lapse following the scheduled smoking lapse were dependent on treatment order (p = .001); among participants who received placebo in the first period, varenicline increased days of abstinence in the follow-up period.These data identify novel affective and cognitive effects of varenicline and may have implications for medication development for other neuropsychiatric conditions.
| S-EPMC2615779 | biostudies-literature
Project description:INTRODUCTION:Behavioral Activation is a behavioral-based treatment that has been proposed as suitable for smoking cessation, as it simultaneously addresses reinforcement-related variables and also mood management. The aim of this study was to compare the effects of a cognitive-behavioral smoking cessation treatment with components of behavioral activation (SCBSCT-BA) with a standard cognitive-behavioral treatment (SCBSCT), and a wait-list control group (WL). METHOD:The sample was comprised of 275 adults smokers (61.4% females, mean age = 45.36, SD = 10.96). After baseline assessment sessions, participants were randomized (ratio: 2.2.1.) to SCBSCT-BA, SCBSCT, or WL. Active groups received 8 weekly 1-hour face-to-face group sessions. Biochemically verified smoking abstinence and depressive symptoms were assessed at the end of treatment, and at 3-, 6-, and 12-month follow-ups. RESULTS:Significant treatment effects in 7-dayspoint prevalence abstinence rates were found for both active groups at the end of treatment. Abstinence rates at 12-months follow-up were 30% for SCBSCT-BA, and 18% for SCBSCT. Using Multiple Imputation for missing data, regression analysis showed significantly greater ORs for the SCBSCT-BA condition (vs. SCBSCT) at the end of treatment and at 3-months follow-up. At 6-, and 12-months follow-ups, ORs for the SCBSCT-BA condition, although greater, did not reach statistical significance. Multilevel analysis showed that abstinence was related to reductions in depressive symptoms. CONCLUSIONS:SCBSCT-BA obtained positive results at short and medium term. Participants who quit smoking experienced a significant reduction in depressive symptoms. Findings support the benefit of adding BA to a cognitive-behavioral smoking cessation treatment. TRIAL REGISTRATION:www.clinicaltrials.gov NCT02844595.
| S-EPMC6453447 | biostudies-literature
Project description:IntroductionMedication sampling is a clinically useful tool to engage smokers in the quitting process. Whether varenicline is suitable for sampling purposes is unclear. The purpose of this study was to examine the feasibility, uptake, and preliminary outcomes of varenicline sampling.MethodsSmokers (N = 99), both motivated to quit and not, were recruited and randomized to varenicline sampling versus not, with 12 week follow-up. The intervention consisted of mailing one-time samples of varenicline (lasting 2-4 wks), with minimally suggestive guidance on use.ResultsUptake of varenicline was strong, at 2 weeks (54% any use, 66% daily use) and 4 weeks (38%, 46%), with 58% of medication users seeking additional medication. Most users followed conventional titration patterns, self-titrating from 0.5 mg to 2 mg. Relative to control, varenicline sampling increased motivation (p = 0.006) and confidence to quit (p = 0.02), and decreased cigarette smoking (p = 0.02). Smokers receiving varenicline samples were significantly more likely to achieve 50% reduction in cigarettes per day (CPD), both immediately following the sampling exercise (Adjusted Odds Ratio [AOR] = 4.12; 95% CI: 1.39 to 12.17) and at final follow-up (AOR = 4.50; 95% CI: 1.56 to 13.01). Though cessation outcomes were not statistically significant, there was a 1.5 to 3-fold increase in quit attempts and abstinence from varenicline sampling throughout follow-up. These outcomes were comparable among smokers motivated to quit and not.ConclusionsUnguided, user-driven sampling of varenicline sampling is a concrete behavioral exercise that is feasible to do and seems to suggest clinical utility. Sampling is a pragmatic clinical approach to engage more smokers in quitting.ImplicationsUse of evidence-based pharmacotherapies for smoking cessation is low. Medication sampling is a pragmatic behavioral exercise that allows smokers to experience the benefits of using them, while promoting positive downstream effects towards quitting. While previous studies have shown that nicotine replacement therapy (NRT) sampling is viable and effective, whether this extends to varenicline is unclear. Results from this trial demonstrate that varenicline sampling is feasible, safe, and suggestive of clinically important steps toward quitting, deserving of a larger trial.Clinical trial registrationNCT #03742154.
| S-EPMC8150130 | biostudies-literature
Project description:ImportanceSome cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.ObjectiveTo determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.Design, setting, and participantsRandomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries. The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months. Participants were recruited through advertising.InterventionsTwenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50% or more in number of cigarettes smoked by 4 weeks, 75% or more by 8 weeks, and a quit attempt by 12 weeks.Main outcomes and measuresPrimary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24. Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52.ResultsThe varenicline group (n = 760) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group (n = 750) (32.1% for the varenicline group vs 6.9% for the placebo group; risk difference (RD), 25.2% [95% CI, 21.4%-29.0%]; relative risk (RR), 4.6 [95% CI, 3.5-6.1]). The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 (37.8% for the varenicline group vs 12.5% for the placebo group; RD, 25.2% [95% CI, 21.1%-29.4%]; RR, 3.0 [95% CI, 2.4-3.7]) and weeks 21 through 52 (27.0% for the varenicline group vs 9.9% for the placebo group; RD, 17.1% [95% CI, 13.3%-20.9%]; RR, 2.7 [95% CI, 2.1-3.5]). Serious adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P = .07).Conclusions and relevanceAmong cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment, and also at 1 year. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation.Trial registrationclinicaltrials.gov Identifier: NCT01370356.
| S-EPMC4883651 | biostudies-literature