A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking

Aims To examine the effectiveness of smoking reduction counselling plus free nicotine replacement therapy (NRT) for smokers not willing to quit. Design, setting and participants A total of 1154 Chinese adult smokers not willing to quit but who were interested in reducing smoking were allocated randomly to three arms. Intervention group A1 (n = 479) received face‐to‐face counselling on smoking reduction and adherence to NRT at baseline, 1 week and 4 weeks with 4 weeks of free NRT. Group A2 (n = 449) received the same intervention, but without the adherence intervention. Control group B (n = 226) received simple cessation advice at baseline. Measurements Self‐reported 7‐day point prevalence of tobacco abstinence and reduction of cigarette consumption (≥50%) at 6 months and continuous use of NRT for 4 weeks at 3 months. Findings Using intention‐to‐treat analysis, compared to control group B, the intervention groups (A1 + A2) had achieved higher 6‐month tobacco abstinence (17.0% versus 10.2%, P = 0.01) and reduction rates (50.9% versus 25.7%, P < 0.001). There was no significant difference in the 4‐week NRT adherence rate at 3 months, but group A1 achieved a higher abstinence rate than group A2 at 6 months (20.9% versus 12.9%; P = 0.001). Conclusions In smokers with no immediate plans to quit, smoking reduction programmes with behavioural support and nicotine replacement therapy are more effective than brief advice to quit. Current guidelines recommend advice to quit on medical grounds as the best clinical intervention in this group of smokers, but smoking reduction programmes offer an alternative and effective option.     

Does improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial

Aims To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Design Single‐blind, randomized controlled trial. Setting New Zealand. Participants A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. Measurements The primary outcome was 7‐day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. Findings No differences in 6‐month quit rates (7‐day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self‐reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). Conclusions In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1‐week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period.     

Pre‐cessation nicotine replacement therapy: pragmatic randomized trial

Aims To determine the effectiveness of 2 weeks' pre‐cessation nicotine patches and/or gum on smoking abstinence at 6 months. Design Pragmatic randomized controlled trial. Setting New Zealand. Participants Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. Measurements The primary outcome was self‐reported 7‐day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine‐verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. Findings Six months after quit day 125 (22.7%) participants in the pre‐cessation group and 116 (21.0%) in the control group reported 7‐day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: ?3.2%, 6.6%). However, when pooled in a meta‐analysis with other pre‐cessation trials a moderate benefit of about a one‐quarter increase in cessation rates was evident. There was no difference in adverse events between groups. Conclusions In this, the largest pre‐cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre‐cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.     

Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities

Aims To assess the efficacy of nicotine replacement therapies (NRT) when the daily dose was adapted according to saliva cotinine concentrations. Design Randomized, multi‐centre, single‐blind, controlled trial. Setting Twenty‐one smoking cessation clinics in France. Participants A total of 310 smokers with medical comorbidities, motivated to quit, smoking ≥10 cigarettes/day, for whom smoking cessation was mandatory. NRT was administered for 3 months. The standard care group received nicotine patches with monthly dose decreases; buccal absorption NRT could be co‐administered at the discretion of the investigator. In the dose adaptation group, the aim was a 100 ± 5% nicotine substitution with respect to smoking state based on the determination of saliva cotinine concentrations. NRT daily doses were prescribed according to the previous week's saliva cotinine concentrations in the dose adaptation group; saliva cotinine concentrations were not provided in the standard care group. Measurements Prolonged abstinence rate (weeks 9–12, main outcome measure), point‐prevalence and continuous abstinence rate, saliva cotinine concentration, NRT daily dose, craving for cigarettes. Findings The median daily prescribed NRT dose was 30 and 31 mg/day in the first study week and 17.25 and 35.5 mg/day during weeks 9–12 in the standard care group and dose adaptation group, respectively. Saliva cotinine remained stable in the dose adaptation group and decreased in the standard care group (P < 0.01) by weeks 9–12. The cotinine substitution rate was significantly lower in the standard care group than in the dose adaptation group. Despite differences in NRT doses and cotinine substitution rates, prolonged (standard care group: 26.4%, dose adaptation group: 30.3%), continuous (standard care group: 8%, dose adaptation group: 12%) and point‐prevalence abstinence rates were similar. Conclusions In smokers with medical comorbidities and highly motivated to quit, adaptation of the nicotine replacement therapy daily dose according to saliva cotinine does not appear to be substantially superior to standard nicotine replacement therapy use.     

A randomized controlled trial of oral selegiline plus nicotine skin patch compared with placebo plus nicotine skin patch for smoking cessation

Objectives To compare the effect of oral selegiline plus nicotine patch with placebo plus nicotine patch on smoking cessation rates. Design Randomized double‐blind placebo‐controlled trial. Setting Three community‐based clinics. Participants One hundred and nine male and female smokers aged 18–55 years, who smoked at least 15 cigarettes/day. Interventions Oral selegiline, 2.5 mg, or placebo twice/day initiated 1 week before the quit day, followed by 5 mg oral selegiline or placebo twice daily for 26 weeks, plus active nicotine skin patch to all participants for the first 8 weeks only. Measures of continuous abstinence rates up to 52 weeks, withdrawal symptoms, blood pressure and adverse events incidence. Findings Twenty‐five per cent (14 of 56) were continuously abstinent for 52 weeks in the selegiline plus nicotine group compared with 11% (6 of 53) in the placebo plus nicotine group (P = 0.08). Craving for cigarettes was lower in the selegiline plus nicotine group 4 weeks after quit day (P = 0.02). Conclusions Adding selegiline to nicotine patch was associated with a doubling of the 52‐week continuous abstinence rate, but this difference was not statistically significant. Selegiline significantly reduced craving for cigarettes and appeared to mitigate the need for nicotine replacement therapy. The results suggest that selegiline is a promising drug for future smoking cessation research.     

An HIV-tailored quit-smoking counselling pilot intervention targeting depressive symptoms plus Nicotine Replacement Therapy

Cardiovascular disease (CVD) rates among people living with HIV/AIDS (PHAs) are high. Rates of cigarette smoking, a leading contributor to CVD among PHAs, are 40–70% (2–3 times higher than the general population). Furthermore, PHAs have high rates of depression (40–60%), a risk factor for smoking cessation relapse. The current pilot study examined the effectiveness of a specifically tailored 5-session smoking cessation counselling programme for PHAs, which addressed depression, in combination with Nicotine Replacement Therapy (NRT) in a cohort of PHA smokers (n?=?50). At 6-month follow-up, 28% of participants demonstrated biochemically verified abstinence from smoking. This result compares favourably to other quit-smoking intervention studies, particularly given the high percentage of HIV+ smokers with depression. At study baseline, 52% of HIV+ smokers scored above the clinical cut-off for depression on the Centre for Epidemiological Studies – Depression (CES-D) scale. HIV+ smokers with depression at study baseline demonstrated quantitatively lower depression at 6-month follow-up with a large effect size (d?=?1), though it did not reach statistical significance (p?=?.058). Furthermore, those with depression were no more likely to relapse than those without depression (p?=?.33), suggesting that our counselling programme adequately addressed this significant barrier to smoking cessation among PHAs. Our pilot study indicates the importance of tailored programmes to help PHAs quit smoking, the significance of addressing depressive symptoms, and the need for tailored counselling programmes to enhance quit rates among PHAs.     

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.     

The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial

Aim To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit. Design Single‐blind, parallel randomized trial. Setting New Zealand. Participants Smokers who called the Quitline for quitting support were randomized to either VLNC cigarettes to use whenever they had an urge to smoke for up to 6 weeks after their quit date, in combination with usual Quitline care (8 weeks of NRT patches and/or gum or lozenges, plus behavioural support) or to usual Quitline care alone. Measurements The primary outcome was 7‐day point‐prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, self‐efficacy, alcohol use, serious adverse events and views on the use of the VLNC cigarettes at 3 and 6 weeks and 3 and 6 months. Findings A total of 1410 participants were randomized (705 in each arm), with a 24% loss to follow‐up at 6 months. Participants in the intervention group were more likely to have quit smoking at 6 months compared to the usual care group [7‐day point‐prevalence abstinence 33 versus 28%, relative risk (RR) = 1.18, 95% confidence interval (CI): 1.01, 1.39, P = 0.037; continuous abstinence 23 versus 15%, RR = 1.50, 95% CI: 1.20, 1.87, P = 0.0003]. The median time to relapse in the intervention group was 2 months compared to 2 weeks in the usual care group (P < 0.0001). Conclusions Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.     

Smoking cessation post-discharge following nicotine replacement therapy use during an inpatient admission

Background: Cigarette smoking remains a health issue despite declining prevalence in Australia. The burden of tobacco‐related morbidity affects hospitals, particularly those in lower socioeconomic areas where prevalence is highest. Aim: We have shown that nicotine replacement therapy (NRT) use during hospitalization increases motivation to quit post‐discharge. We postulated that subjects using the nicotine patch post‐discharge, in comparison to the inhaler, would have higher rates of abstinence at 12 months after discharge. The aim was to compare the efficacy of the nicotine patch or inhaler formulation for cessation post‐discharge, following use during admission. Methods: Post‐discharge, subjects chose their preferred formulation (patch or inhaler) based on their experience with NRT during admission. Tailored, medium‐intensity support was provided with subsidized NRT during outpatient visits. Subjects were followed for 12 months. Exhaled breath CO confirmed non‐smoking. Results: Of 123 subjects enrolled, 37 elected to use the inhaler, 50 the patch and 36 no NRT. At 12 months continuous abstinence rates were 38%, 38% and 25% respectively. Discussion: This study built upon the ‘teachable moment’ provided by hospitalization and the inpatient use of NRT, encouraging cessation post‐discharge. Both NRT formulations provided similar 12 month cessation rates, and were superior to those achieved by subjects electing not to use NRT. Although the patch was the most popular formulation, the inhaler provided an equally efficacious alternative which addressed other facets of cigarette addiction. Subjects electing not to use NRT were less successful. Continuous abstinence rates were equivalent to community‐based studies using NRT. We recommend a similar programme to other hospitals.     

A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers

AIMS: To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine). DESIGN: Multi-center (n = 4), double-blind, randomized, parallel group, repeat-dose study. SETTING: Clinical laboratory. PARTICIPANTS: A total of 540 subjects were enrolled into the study-135 from each of four sites; 180 patients in each of three treatment arms. INTERVENTION: Treatment was administered for the first 6 weeks of the 8-week study. Patients were instructed to continue smoking for the first 2 weeks of treatment. MEASUREMENTS: The primary efficacy parameter was 4-week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million. FINDINGS: Analysis of the 4-week continuous abstinence for the intent-to-treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non-significant group differences (29%, 27%, 26%). CONCLUSION: If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.     

Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial

Aims To determine whether 2‐week pre‐treatment with transdermal nicotine influences withdrawal symptoms or success rate of subsequent smoking cessation using nicotine patches. Design Randomized controlled trial. Setting Smoking cessation clinic. Participants Healthy smokers (n = 200, 45% female) were allocated randomly to either active nicotine‐patch (AP, 15 mg daily, n = 100) or placebo‐patch (PP, n = 100) pre‐treatment. Baseline characteristics were well balanced except for daily cigarette consumption: mean (± SD) 23.1 (8) and 26.4 (11) for AP and PP groups, respectively (P = 0.021). Intervention At the screening visit (? 2 weeks) subjects were counselled and started pre‐treatment with daily patches (AP or PP). From the quit date (week 0) onwards all subjects received active nicotine patches for 12 weeks (15 mg daily for 8 weeks, 10 and 5 mg daily for 2 weeks each) and counselling. Measurements Follow‐up visits included measurement of exhaled carbon monoxide at the quit date, 2, 6, 10 and 26 weeks. Subjects documented daily cigarette consumption and severity of withdrawal symptoms (Wisconsin scale) from ? 2 weeks to week 2. Outcome measures were withdrawal symptoms composite score and abstinence rates. Findings There was no significant difference in withdrawal symptoms, but more subjects in the AP group were smoke‐free during the 6‐month study period. Overall sustained abstinence was documented in 17% of subjects at 6 months; 22% and 12% for AP and PP, respectively (P = 0.03). Retrospective subgroup analysis showed for subjects smoking >16 cigarettes/day sustained cessation rates were 22% and 9% for AP and PP, respectively (P = 0.01). No difference in adverse event rates was observed. Conclusions Nicotine patch pre‐treatment before cessation did not reduce early withdrawal symptoms but increased sustained abstinence rates at 6 months. The nicotine pre‐treatment was equally effective in light and heavy smokers.     

The effectiveness of personalized smoking cessation strategies for callers to a Quitline service

Aim To assess the effectiveness of a program of computer‐generated tailored advice for callers to a telephone helpline, and to assess whether it enhanced a series of callback telephone counselling sessions in aiding smoking cessation. Design Randomized controlled trial comparing: (1) untailored self‐help materials; (2) computer‐generated tailored advice only, and (3) computer‐generated tailored advice plus callback telephone counselling. Assessment surveys were conducted at baseline, 3, 6 and 12 months. Setting Victoria, Australia. Participants A total of 1578 smokers who called the Quitline service and agreed to participate. Measurements Smoking status at follow‐up; duration of cessation, if quit; use of nicotine replacement therapy; and extent of participation in the callback service. Findings At the 3‐month follow‐up, significantly more (χ²(2) = 16.9; P < 0.001) participants in the computer‐generated tailored advice plus telephone counselling condition were not smoking (21%) than in either the computer‐generated advice only (12%) or the control condition (12%). Proportions reporting not smoking at the 12‐month follow‐up were 26%, 23% and 22%, respectively (NS) for point prevalence, and for 9 months sustained abstinence; 8.2, 6.0, and 5.0 (NS). In the telephone counselling group, those receiving callbacks were more likely than those who did not to have sustained abstinence at 12 months (10.2 compared with 4.0, P < 0.05). Logistic regression on 3‐month data showed significant independent effects on cessation of telephone counselling and use of NRT, but not of computer‐generated tailored advice. Conclusion Computer‐generated tailored advice did not enhance telephone counselling, nor have any independent effect on cessation. This may be due to poor timing of the computer‐generated tailored advice and poor integration of the two modes of advice.     

Effectiveness of a smoking cessation intervention in older adults

AIMS: To: (a) identify characteristics of older smokers considering cessation of smoking; (b) evaluate a cessation intervention plus access to nicotine replacement therapy (NRT); (c) identify predictors of those who successfully quit; and (d) evaluate the effectiveness of the intervention in those AGED >or = 75 years. DESIGN: Self-selection of: (a) a cessation of smoking programme; or (b) ongoing smoking. SETTING: Teaching hospital, Perth, Western Australia. PARTICIPANTS: A larger study recruited smokers and never smokers: from this the 215 community-dwelling smokers (>or= 5 cigarettes/day) aged >or= 68 years (171 males) were enrolled. INTERVENTION: Brief intervention with telephone support and access to NRT versus no intervention. MEASUREMENTS: (a) Profile of older adults planning to quit smoking compared with continuing smokers; (b) cessation at 6 months defined as 30-day point prevalence validated via expired carbon monoxide; and (c) factors predictive of successful cessation. FINDINGS: There were 165 intervention participants. Compared with the 50 continuing smokers, participants in the intervention were younger and had significantly less years of regular smoking, more previous quit attempts and greater nicotine dependence scores. At 6 months, the point prevalence of ex-smokers was 25% (n = 42) with 20% (n = 33) being abstinent throughout the study. No continuing smoker had ceased smoking. Among the intervention group, logistic regression showed that those who used NRT (OR 4.36), were male (OR 3.17), had higher anxiety (OR 1.67) or rejected 'more colds and coughs' as a reason for quitting (OR 2.91) were more likely to be successful quitters. Of those aged >or= 75 years (n = 77), 25% matched cessation criteria. CONCLUSIONS: Older smokers can be engaged successfully in a brief intervention plus NRT as aids to cessation of smoking. The intervention was also effective in the older subgroup of participants. Social factors may provide an additional means of motivating older smokers to quit.     

Impact of messages on concomitant use of nicotine replacement therapy and cigarettes: a randomized trial on the Internet

Aims To assess the impact of messages recommending the concomitant use of nicotine replacement therapy (NRT) and cigarettes on smokers’ intention to quit smoking. Design Randomized trial. Setting Internet. Participants A total of 2027 people who answered an e‐mail sent to 9074 current and former smokers recruited on a smoking cessation website. Intervention Participants were divided randomly into four groups, each of which received a unique message (in French) by e‐mail. The ‘control’ message said that nicotine replacement therapy (NRT) attenuates withdrawal symptoms in smokers who want to quit. The ‘temporary abstinence’ message added that NRT can also be used by current smokers to manage smoke‐free situations. The ‘reduction’ message indicated that NRT can be used by current smokers who do not want to quit but want to smoke fewer cigarettes. The ‘side‐effects’ message discouraged concomitant use of NRT and cigarettes. Measurements Perceived impact of these messages on motivation to quit smoking. Findings The e‐mail was answered by 2027 people (25% of 8124 valid addresses). Smokers who received the ‘reduction’ message were slightly more likely than controls to report that this message increased their motivation to quit (66% versus 60%, P = 0.02). In contrast, smokers who received the ‘side‐effects’ message were less likely than controls to report that this message increased their motivation (45% versus 60%, P < 0.001). The ‘temporary abstinence’ message had no detectable impact on motivation to quit. Conclusions Among smokers recruited via a smoking cessation website, messages encouraging concomitant use of NRT and cigarettes may have either no effect or a positive effect on motivation to quit smoking.     

Nicotine replacement therapy

AIM: To determine the association between daily smoking and use of nicotine replacement therapy (NRT), and to determine predictors of greater NRT use among methadone-maintained smokers. INTERVENTION: Assignment to free nicotine patch (8 to 12 weeks) plus either (1) a baseline-tailored brief motivational intervention, a quit date behavioral skills counseling session, and a relapse prevention follow-up session (max), or (2) brief advice using NCI's 4 A's model (min). SETTING: Five methadone maintenance treatment centers. PARTICIPANTS: Of the 383 methadone-maintained smokers enrolled, 309 (80.6%) set a specific quit date (received NRT) and were located for assessments. Participants were 51.8% male, 78.6% Caucasian, and smoked 26.6 (SD=12.2) cigarettes/day. OUTCOME: Use of NRT and smoking behaviors during the 180-day follow-up period assessed by the Timeline follow-back method. FINDINGS: On the day following their quit day, 86.4% of participants used NRT. The percentage of participants using NRT was 52.3%, 27.1%, and 10.4% on day 30, day 60, and day 90, respectively. Participants used NRT on 44.1% of the days through the 90 days of the treatment protocol. The estimated odds of smoking abstinence was 7.1 (P<.001) times higher on days when NRT was used than on days when NRT was not used, and cigarettes/day was also significantly lower on NRT days (14.93 vs 4.65; P<.001). CONCLUSION: Nicotine replacement therapy use was inconsistent following an initial quit attempt among methadone-maintained smokers. On days when NRT was used, individuals were likely to smoke at reduced levels or not at all.     

Anxiety diagnoses in smokers seeking cessation treatment: relations with tobacco dependence, withdrawal, outcome and response to treatment

Aims To understand the relations among anxiety disorders and tobacco dependence, withdrawal symptoms, response to smoking cessation pharmacotherapy and ability to quit smoking. Design Randomized placebo‐controlled clinical trial. Participants received six 10‐minute individual counseling sessions and either: placebo, bupropion SR, nicotine patch, nicotine lozenge, bupropion SR + nicotine lozenge or nicotine patch + nicotine lozenge. Setting Two urban research sites. Participants Data were collected from 1504 daily smokers (>9 cigarettes per day) who were motivated to quit smoking and did not report current diagnoses of schizophrenia or psychosis or bupropion use. Measurements Participants completed baseline assessments, the Composite International Diagnostic Interview and ecological momentary assessments for 2 weeks. Findings A structured clinical interview identified participants who ever met criteria for a panic attack (n = 455), social anxiety (n = 199) or generalized anxiety disorder (n = 99), and those who qualified for no anxiety diagnosis (n = 891). Smokers with anxiety disorders reported higher levels of nicotine dependence and pre‐quit withdrawal symptoms. Those ever meeting criteria for panic attacks or social anxiety disorder showed greater quit‐day negative affect. Smokers ever meeting criteria for anxiety disorders were less likely to be abstinent at 8 weeks and 6 months post‐quit and showed no benefit from single‐agent or combination‐agent pharmacotherapies. Conclusions Anxiety diagnoses were common among treatment‐seeking smokers and were related to increased motivation to smoke, elevated withdrawal, lack of response to pharmacotherapy and impaired ability to quit smoking. These findings could guide treatment assignment algorithms and treatment development for smokers with anxiety diagnoses.     

The effect of a minimal intervention strategy in addition to nicotine replacement therapy to support smoking cessation in cardiovascular outpatients: a randomized clinical trial.

BACKGROUND: Smoking is an important risk factor for recurrent events in cardiovascular patients. Evidence exists that nicotine replacement therapy (NRT) approximately doubles smoking cessation rates. The minimal intervention strategy (MIS) has been used successfully to assist patients to quit smoking in general practice, and was recently adapted for cardiology inpatients (C-MIS). It is hypothesized that in cardiovascular outpatients the combination of C-MIS and NRT significantly increases the number of quitters compared to NRT alone. METHODS: A randomized clinical trial in 385 smoking patients who attended the cardiovascular outpatient departments in the Academic Medical Centre, Amsterdam for the treatment of atherosclerotic disease. Patients were allocated to either NRT + C-MIS or NRT alone. Self-reported and biochemically validated abstinence rates were measured at 12 months' follow-up. RESULTS: Including patients with incomplete follow-up as smokers, abstinence was reported by 19% of the NRT + C-MIS group and 14% of the NRT group [absolute risk reduction (ARR) = 0.05; 95% confidence interval (CI) = -0.02; 0.12]. According to biochemical markers, abstinence rates were 28 and 24%, respectively (ARR = 0.04, 95% CI = -0.06; 0.14). Hence, no significant differences between groups were found. The number of cigarettes smoked a day decreased significantly at 12 months: from 21 to 15 a day in the experimental group, and from 21 to 14 in the control group (P<0.001), but did not differ between groups (P=0.32). CONCLUSIONS: The effectiveness of a minimal contact intervention was investigated in order to reach as many cardiovascular patients as possible in the setting of outpatient departments. This intervention was not found to be effective.     

Smoking cessation in methadone maintenance

Aims To evaluate relapse prevention (relapse prevention) and contingency management (contingency management) for optimizing smoking cessation outcomes using nicotine replacement therapy for methadone‐maintained tobacco smokers. Design Experimental, 2 (relapse prevention)×2 (contingency management) repeated measures design using a platform of nicotine replacement therapy featuring a 2‐week baseline period, followed by randomization to 12weeks of treatment, and 6‐ and 12‐month follow‐up visits. Setting Three narcotic treatment centers in Los Angeles. Participants One hundred and seventy‐five participants who met all inclusion and no exclusion criteria. Intervention Participants received 12weeks of nicotine replacement therapy and assignment to one of four conditions: patch‐only, relapse prevention + patch, contingency management + patch and relapse prevention + contingency management + patch. Measurements Thrice weekly samples of breath (analyzed for carbon monoxide) and urine (analyzed for metabolites of opiates and cocaine) and weekly self‐reported numbers of cigarettes smoked. Findings Participants (73.1%) completed 12weeks of treatment. During treatment, those assigned to receive contingency management showed statistically higher rates of smoking abstinence than those not assigned to receive contingencies (F_3,4680=6.3, P=0.0003), with no similar effect observed for relapse prevention. At follow‐up evaluations, there were no significant differences between conditions. Participants provided more opiate and cocaine‐free urines during weeks when they met criteria for smoking abstinence than during weeks when they did not meet these criteria (F_1,2054=14.38, P=0.0002; F_1,2419=16.52, P<0.0001). Conclusions Contingency management optimized outcomes using nicotine replacement therapy for reducing cigarette smoking during treatment for opiate dependence, although long‐term effects are not generally maintained. Findings document strong associations between reductions in cigarette smoking and reductions in illicit substance use during treatment.