Category: Tobacco

Key Takeaways

 

• Participants who were assigned VLNC cigarettes smoked fewer cigarettes per day (14.9) than those assigned to their usual brand (22.2)

 

• Smokers of VLNC cigarettes doubled their quit attempts versus smokers of conventional cigarettes

 

• Funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA)

Abstract

 

BACKGROUND

The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes.

METHODS

We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6.

RESULTS

A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups.

CONCLUSIONS

In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875. opens in new tab.)

Key Takeaways

 

• The group that used VLNC cigarettes had a 70% quit rate one week after stopping VLNC cigarette use compared to a 53% quit rate of the group not using VLNC cigarettes

 

• Adding VLNC cigarettes to standard treatments has the potential to assist smokers early in their quit attempt, but research is needed to determine how best to utilize them.

 

• Funded by Pfizer, Inc.

 

 

Abstract

 

• Introduction: Standard treatments (STs) for smoking cessation typically combine pharmacotherapy and behavioral support but do not address the sensory and behavioral aspects of smoking which may play a role in maintaining smoking behavior. Replacing such sensations temporarily after cessation may enhance treatment efficacy. We hypothesized that denicotinized cigarettes (DNCs), which have a very low nicotine content but provide these sensory and behavioral stimuli, could help alleviate urges to smoke and tobacco withdrawal symptoms and in turn enhance the efficacy of ST.

 

• Methods: Two hundred smokers seeking treatment received nine weekly behavioral support sessions and pharmacotherapy (100 used varenicline, 100 used nicotine replacement therapy). They were randomized on the target quit day to receive 280 DNCs (used ad libitum over 2 weeks in addition to ST) or ST alone.

 

• Results: Urge-to-smoke frequency (2.61 vs. 2.96, P = .03) but not strength (2.85 vs. 3.10, P = .20) in the first week of abstinence was significantly lower in DNC users versus ST alone. There were no differences in composite withdrawal scores between groups. Abstinence was significantly higher among DNC users versus ST alone at 1 (OR = 2.07; 95% CI: 1.63% to 3.70%) and 4 weeks (OR = 1.83; 95% CI: 1.05% to 3.21%), but not at 12 weeks (OR = 1.42; 95% CI: 0.79% to 2.55%). DNC use was a significant predictor of abstinence at 1 and 4 weeks (OR = 2.63; 95% CI: 1.40% to 4.93% and OR = 2.38; 95% CI: 1.26% to 4.46%), but not at 12 weeks.

 

• Conclusions: Adding DNCs to ST has the potential to assist smokers early in their quit attempt, but research is needed to determine how best to utilize DNCs in treatment.

 

Key Takeaways

 

• Reducing the nicotine content of cigarettes is a potential regulatory strategy that may enable cessation

 

• When smoking Very Low Nicotine Content cigarettes, lower levels of nicotine exposure prior to a quit attempt enables cessation

 

• Funded by the National Institutes of Health (NIH), (grant id: R01 DA025598 and U54DA031659)

 

Abstract

 

Key Takeaways

 

• VLNC cigarettes produced significantly better results than FDA-approved nicotine lozenges; even those smokers who ultimately didn’t quit ended up reducing their cigarette consumption from 19 cigarettes per day to 12 cigarettes per day

 

• Very Low Nicotine Content cigarettes were associated with greater relief of withdrawal than the nicotine lozenge

 

• Funded by the National Institutes of Health (NIH), (grant id: R01 DA025598 and U54DA031659)

 

Abstract

 

• Background: Reduced nicotine content (RNC) cigarettes have led to smoking fewer cigarettes, withdrawal relief, and facilitation of cessation. The aim of this study is to examine the effects RNC cigarettes with and without nicotine patch and patch alone on smoking behavior, toxicant exposure, withdrawal discomfort, and as an exploratory analysis, on long-term abstinence.

 

• Methods: This study involved a randomized, parallel arm design and six weeks of: (i) 0.05-0.09 mg nicotine yield cigarettes (N = 79); (ii) 21 mg nicotine patch (N = 80), or (iii) 0.05-0.09 nicotine yield cigarettes with 21 mg nicotine patch (N = 76); all groups received six weeks of additional behavioral treatment with follow-ups up to six months.

 

• Results: Combination approach led to lower rates of smoking assigned cigarettes and hence lower carbon monoxide levels than RNC cigarettes alone. In addition, the combination approach was associated with less withdrawal severity when switching from usual brand to assigned product, and less smoking of usual brand cigarettes during treatment, but not after treatment compared with the other approaches.

 

• Conclusion: Combining very low nicotine content cigarettes with nicotine patch may improve the acute effects resulting from switching to either of these products alone.

 

• Impact: These findings may have implications for smoking cessation treatment or a policy measure to reduce nicotine content in cigarettes.

 

Key Takeaways

• VLNC cigarettes plus NRT (nicotine patch, gum and/or lozenge) significantly increased quit rates at all measured time points (3 & 6 weeks and 3 & 6 months) over use of NRT only

 

• Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent

 

• Funded by the Health Research Council of New Zealand

 

Abstract

• 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.

 

Key Takeaways

 

• VLNC cigarettes produced significantly better results than the FDA-approved nicotine lozenge; even the smokers who ultimately did not quit ended up reducing their cigarette consumption by 37%

 

• The 0.05 mg nicotine yield cigarettes may be a tobacco product that can facilitate cessation

 

• This study was funded by the National Institutes of Health (NIH), (grant id: P50 DA013333)

 

Abstract

Trial registration: ClinicalTrials.gov NCT00777569.

Key Takeaways

 

• The use of reduced nicotine cigarettes for 6 weeks, including VLNC cigarettes for 2 weeks, before the use of the nicotine patch significantly increased quit rates over use of the nicotine patch alone

 

• VLNC cigarettes plus nicotine replacement therapy offers promise as a new smoking cessation treatment.

 

• Funded by Vector Tobacco Inc.

 

Abstract

A randomized double-blind, active controlled, parallel group, multi-center phase II clinical trial was conducted to evaluate the efficacy of reduced-nicotine cigarettes as a novel smoking cessation treatment (under Investigational Device Exemption 69,185). The concept for a reduced-nicotine cigarette designed to progressively wean smokers from the smoking habit is based on research demonstrating that successful smoking cessation is not only dependent on withdrawal of nicotine, but also on weaning from the habitual sensory and behavioral reinforcement of smoking. Treatment consisted of Quest brand of cigarettes (Quest 1, 2, and 3), which respectively deliver 0.59+/-0.06, 0.3+/-0.05, and less than 0.05 mg nicotine, either alone or in combination with nicotine replacement therapy (NRT). The primary endpoint was 4 weeks of continuous abstinence (Weeks 7-10), with additional follow-up at 3 and 6 months. Adult men and women smokers (N = 346), motivated to quit, were randomized to one of three treatment groups: Quest plus NRT (NRT pretreatment 2 weeks before, and NRT after the quit date), Quest plus placebo patch, or active control plus NRT (conventional cigarette, followed by NRT after quit date). Results showed that Quest plus NRT was more effective than active control plus NRT in achieving 4 weeks of continuous abstinence (32.8% vs. 21.9%). Quest plus placebo patch yielded an abstinence rate similar to that of the active control plus NRT (16.4% vs. 21.9%). No serious adverse events were attributable to the investigational product. Quest plus NRT offers promise as a new smoking cessation treatment.

Key Takeaways

 

• Use of VLNC cigarettes before use of nicotine patches increased quit rates over similar use of reduced nicotine cigarettes (containing 10 times more nicotine than the VLNC cigarettes) before nicotine patches

 

• The use of VLNC cigarettes combined with the nicotine patch appears to lessen cravings to smoke in the immediate post cessation period

 

• Funded by institutional resources from Roswell Park Cancer Institute

 

Abstract

 

The present study investigated whether treatment with the combination of denicotinized cigarettes and 21-mg nicotine patch for 2 weeks before a designated quit date could lessen cravings for smoking, thereby helping smokers abstain from smoking. The study was a randomized controlled clinical trial conducted at Roswell Park Cancer Institute, Buffalo, New York, in 2004 and 2005. Patients included 98 adult heavy smokers (using 20 or more cigarettes/day). Half of the subjects received 2 weeks of combination of denicotinized cigarettes (Quest 3) and 21-mg nicotine patch for 2 weeks before the quit date. The remaining smokers were switched to light cigarettes (Quest 1) during the 2 weeks before the quit date. After the quit date, all subjects received counseling for smoking cessation and were provided nicotine patches for up to 8 weeks after the quit date. Self-reported cravings for smoking, withdrawal symptoms, and smoking abstinence were measured at predetermined intervals using phone-based surveys and in clinical visits. The group that used denicotinized cigarettes and nicotine patch before quitting reported less frequent and less intense cravings for cigarettes in the 2 weeks before and after the designated quit date. Self-reported withdrawal symptoms and quit rates did not differ significantly between the groups. The use of a denicotinized cigarette combined with the nicotine patch appears to lessen cravings to smoke in the immediate postcessation period. A larger, better-powered study is needed to test if this treatment combination has merit for increasing quit rates.