Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation

Considering how accessible pharmacists are and how well suited they are to interact with patients obtaining smoking cessation medications, pharmacists can be instrumental in delivering programs to patients and hopefully improve quit rates for smokers. This study explored the idea of utilizing a pharmacist team (a licensed clinical pharmacist and APPE students) in order to deliver a smoking cessation program face-to-face. The researchers compared outcomes from this approach with that of a method that involved brief telephone assistance to patients aiming to quit smoking. Outcomes were measured through the 7-day point prevalence quit rates, Fagerstrom Test for Nicotine Dependence scale, Perceived Stress Scale, and Center for Epidemiological Studies Short Depression Scale, as well as questionnaires regarding self-efficacy, motivation to quit smoking, and withdrawal symptoms. Biological measures of smoking, including cotinine levels, were also assessed. In addition to the two interventions, participants had a choice to receive either bupropion IR (Zyban®) tablets or nicotine patches.

The group receiving face-to-face treatment from the pharmacist team had a quit rate of 28% confirmed by the 7-day point prevalence and cotinine levels, while the standard care group receiving phone calls had a quit rate of 11.8%. Pharmacist-delivered face-to-face care seems to be beneficial in improving outcomes for those wanting to quit smoking. Perhaps collaborative practice agreements that allow pharmacists to prescribe smoking cessation medications can be developed to help improve quit rates. Pharmacists can be uniquely suited to this approach as they are so accessible and can help patients through all the aspects of taking smoking cessation medications– dispensing, counseling, and monitoring for efficacy, safety, and adherence.

 

Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother. 2009; 43:193-201.

Randomized Trial of Four Financial-Incentive Programs for Smoking Cessation

Smoking cessation is still a heavily researched and talked about topic.  While quitting smoking may seem simple to a non-smoker, the reality is that trying to stop smoking can be a difficult and expensive choice.  This study looked at how financial incentives may increase sustained abstinence from smoking.

2,538 people enrolled in the study and were then assigned to either one of four incentive programs or the usual care for smoking cessation.  Of the the four incentive programs, two were targeted to individuals and two were targeted to groups of six.  These two groups then differentiated by being either a reward-based program or a deposit-based program (refundable deposit plus a reward).  The results of the study showed that while 90% of participants accepted the assignment when the program was reward-based, only 13.7% of participants accepted the assignment when the program was deposit-based.  After six months, rates of sustained abstinence were higher for every program (9.4% to 16.0%) than the basic care group (6.0%).  Additionally, the reward-based programs had higher abstinence rates than the deposit-based programs.

I found the results of this study surprising.  I understand that stopping smoking can be extremely difficult but I still expected the percentage of abstinence to be higher when the reward was $800 for six months of abstinence.  One of the programs had an extremely high denial rate.  It required people to deposit $150 dollars, which they would get back if they successfully completed the six months.  After seeing the results, I now understand why the amount was so low.  Incentive-programs like these do make a significant difference.  However, with the percentages being so low I find it hard to believe that anyone would fund the program without a financial incentive, which only comes from the deposit-based reward system that most smokers would not attempt.

Halpern SD, French B, Small DS, et al. Randomized Trial of Four Financial-Incentive Programs for Smoking Cessation. N Engl J Med. 2015;372(22):2108-117.

http://www.nejm.org/doi/full/10.1056/NEJMoa1414293#t=articleMethods

Pilot study of Psilocybin in the Treatment of Tobacco Addiction

It seems strange that a drug of abuse, psilocybin, could be used to treat dependence of another drug, nicotine– but this study explores the potential efficacy of this unconventional therapy. Previous research from the 1950s-1970s showed that hallucinogens may be effective in treating drug dependence, such as alcoholism and opioid dependence. A more recent study, performed with the rigor and controls of modern research, has shown the potential for psilocybin to reduce anxiety and depression in those with advanced stage cancer and that these effects lasted well beyond the time of administration. Typical smoking cessation pharmacotherapy result in modest 6-month success rates (often less than 35%), so this study aimed to test the safety and potential efficacy of using psilocybin for smoking cessation.

This study recruited 15 subjects to participate in a 15-week open label pilot trial. Inclusion criteria was smoking at least 10 cigarettes a day, having several unsuccessful past attempts at quitting, and current desire to quite. Every participant went to a weekly cognitive behavioral therapy session for the first 4 weeks and then received a moderate dose (20 mg/ 70 kg) of psilocybin at week 5. Participants also set a target quit date (TQD) for the day they were receiving their first dose of psilocybin. Two additional psilocybin administrations were offered at weeks 7 and 13 with optional higher dosing (30 mg/ 70 kg). These administrations were intended to be additional quit opportunities for those who did not remain abstinent after the first administration. Participants met with staff to reflect each week throughout the study as well as after each psilocybin session. They also received quick phone calls from the staff for 2 weeks after the TQD for encouragement to quit.

Many measures were taken to ensure safety. Blood pressure and heart rate were monitored throughout the psilocybin sessions, and a physician and rescue medications were available in case adverse events occurred. At each session, participants were encouraged to lie on a couch, wear an eye mask, and listen to a music program. The staff provided interpersonal support to manage any effects of the drug. There were no clinically significant adverse effects experienced by any of the participants during any of the sessions, although blood pressure and heart rate were slightly elevated.

Outcomes measured in this study included exhaled carbon monoxide and urinary cotinine levels, both of which are biological indicators of smoking. Psychological aspects of smoking and dependence were measured through various tests and questionnaires, including the smoking timeline follow-back assessment, Fagerström Test for Cigarette Dependence, Questionnaire on Smoking Urges, Smoking Abstinence Self-Efficacy scale, and Wisconsin Smoking Withdrawal Scale. The effects of psilocybin were monitored through other questionnaires including the Visual Effects Questionnaire, a post-session headache interview, Mysticism Scale, States of Consciousness Questionnaire, Persisting Effects Questionnaire, and a questionnaire to measure if patients believed psilocybin had been efficacious in aiding smoking cessation.

12 out 15 (80%) of the participants demonstrated abstinence at the 6 month follow up via questionnaires and carbon monoxide/ cotinine levels (although 3 of the participants reported self-corrected lapses). There were signifiant reductions in self-reported daily smoking, carbon monoxide and cotinine levels, as well as significant differences in Smoking Abstinence Self-Efficacy confidence, Smoking Abstinence Self-Efficacy temptation, Questionnaire on Smoking Urges, and Wisconsin Smoking Withdrawal Scale scores. Reasons people claimed psilocybin helped with quitting included changing their outlook toward the future, strengthening their confidence in quitting, and changing life priorities and values. Only 1 participant reported that psilocybin did not aid smoking cessation. Participants who managed to quit were able to quit after only the first administration.

More studies, particularly controlled studies, would have to be conducted to support the efficacy of psilocybin in smoking cessation, but this study did show that it can be safe and feasible as an adjunct to smoking cessation treatment. This is promising when considering that current therapies involve many adverse effects and have lower quit rates. It is interesting that only one or a few doses needed to be administered in order for psilocybin to have a lasting effect on smoking cessation. It is also interesting to consider what the mechanism may be as it is not clear from this study how psilocybin can potentially affect smoking habits. While psilocybin is a Schedule I drug, there is no clear evidence that it engenders addiction and this study administered it in a safe and controlled manner.

Johnson MW, et al. Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. J Psychopharmacol. 2014; 28(11):983-92

Motivating smokers with mental illness to quit found to be more effective than educational intervention

Significantly more individuals who smoke that have a mental illness made an attempt to quit after receiving a single 45-minute counseling session compared to those who received an interactive educational intervention. The researchers randomized 98 smokers with serious mental illness to receive either the counseling session or the interactive educational intervention. They found that a significantly greater portion of the patients who received motivational interviewing made an attempt to quit by the 1-month follow-up. The findings suggest that motivational interviewing may be the key to having people with mental illnesses quit smoking.

The researchers say that people who have mental illnesses are less likely to quit compared to those who don’t. Therefore, using motivational interviewing might be the most effective way to get these patients to quit smoking.

I think this article is interesting because it shows the effectiveness of motivational interviewing that we learned about in Community Health 2. Since people told us it is useful, it was cool to find a study that actually showed its effectiveness. Moreover, I think it is also interesting that researchers are trying to determine the best ways to motivate people to see which methods are most effective. My question for the class is: How do you think pharmacists can implement motivational interviewing into their practice?

Reference:

Marc L. Steinberg, Jill M. Williams, Naomi F. Stahl, Patricia Dooley Budsock, Nina A. Cooperman. An Adaptation of Motivational Interviewing Increases Quit Attempts in Smokers With Serious Mental IllnessNicotine & Tobacco Research, 2016; 18 (3): 243 DOI:10.1093/ntr/ntv043

Expanding Cessation Pharmacotherapy Via Videoconference Educational Outreach to Prescribers

According to studies that assessed current smoking rates among the population, it was found that people diagnosed with a mental illness are two to three times more likely to smoke than those who are not. For this reason, this study focused at providing these patients underutilized forms of smoking cessation pharmacotherapy to determine if a change could be made in this pattern. Researchers utilized two different forms of smoking cessation education methods in an attempt to determine the best way to deliver this information to patients. While the first method provided traditional group in-person cessation education sessions,  the second method aimed at determining if the use of videoconferencing technology would be an adequate alternative method for education. Members of the study analyzed the results by examining filled Medicaid pharmacotherapy claims along with the prescribers’ attitudes toward the different forms of education services. Although researchers hypothesized that in-person delivery of smoking cessation programs would be more effective than videoconferencing, they found that there were no significant differences between the two groups of patients receiving this service. They did note that patients receiving either form of this service were more likely to follow through with actions to quit smoking than those who did not.

I believe studies like these are important for future pharmacists to be aware of because it is our goal to make sure that patients are utilizing treatment options in an appropriate matter to ensure that they will receive the best health benefit. Since we are often the easiest person within the health care system for patients to approach with their issues, it is crucial that we know how to counsel them on these types of health-related concerns. Knowing that just providing some form of cessation education improves the likelihood that a patient will attempt to follow actions required to quit harmful behaviors is a positive sign that our work as professionals can have a significant impact on the people we are serving. It is for this reason that we should continually provided counseling services to patients at multiple stages in the treatment process, such as initiation of therapy and follow-ups. I believe that these actions will have a beneficial impact on patients and will make doing our job a much more fulfilling experience. I would be very interested to see how this type of study would show improvement in limiting the harmful impact that other health concerns have on the population.

Brunette MF, Dzebisashvili N, Xie H, et al. Expanding cessation pharmacotherapy via videoconference educational outreach to prescribers. Nicotine Tob Res. 2015;17(8):960-7.

The Proposal for Smoke Free Public Housing

As pharmacy students in a city, we interact regularly with a wide variety of patient populations. It is not uncommon to speak with patients who live in government provided public housing and whose incomes fall below the poverty line. Unfortunately, most of these patients suffer from poor health outcomes. Home life and income are both social determinants of health; smoking rates are higher in these populations than the general population. In fact, though the US smoking rates have dropped in the general adult population to under 17%, yet it remains above 26% in populations with incomes below the poverty line. The effects of smoking reach even further because of secondhand smoke. Therefore, children and people nearby also suffer the consequences of their parents or neighbors smoking. In housing projects, 37% of children experience smoking related health problems simply by second hand smoke.

These are alarming statistics and the US Department of Housing and Urban Development (HUD) is taking action. By the end of 2016, HUD-provided housing will require non-indoor smoking to be listed in the lease agreement. This type of policy has the ability to impact more than 2 million individuals living in 954,000 government provided homes throughout the country. The Public Housing Authorities will be responsible for implementing this rule, and will not allow any form of lit cigars, cigarettes or pipes indoors. Residents will have to walk more than 25 feet away from the property in order to smoke. If a neighbor sees someone smoking, they are encouraged to report it. Though this seems like an intrusion on individual rights, the majority of current residents in public housing are in support of this new rule, as they are currently subjected to excessive second hand smoke through open windows and air vents from their neighbors.

In addition to the obvious health benefits of decreased smoking and second hand smoke, this plan also has several financial perks. A nation-wide effort would result in annual cost savings of $153 million, including $94 million in health care savings and $59 million in reduced poverty costs.

Implementation of a plan like this would help health professionals in the movement for smoking cessation all together. I believe making residents go outside in the cold to smoke rather than in the comfort of their own home will help push the patient to make the decision him/herself to quit. Pharmacists and other health professionals should jump on this opportunity and be ready to provide cessation resources to patients currently addicted to smoking who live in public housing.

Do you think a plan like this is feasible? Do you think this is violating a patient’s right to make personal lifestyle decisions?

 

Read the original article here.

Geller AC, Rees VW, Brooks DR. The Proposal for Smoke-Free Public Housing: Benefits, Challenges, and Opportunities for 2 Million Residents. JAMA. 2016;1380

Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation

Smoking tobacco is a widespread problem throughout the world, and there have been many attempts to create pharmacotherapies for smoking cessation. A study in the Journal of the American Medical Association compared traditional nicotine replacement therapy (NRT), varenicline, and a combination nicotine replacement therapy (C-NRT) in 1086 smokers. The difference in abstinence rates between the NRT patch and the other two therapies were not considered to be significant. It was also found that those in the C-NRT and varenicline groups had significantly lower withdrawal ratings than those just using the patch. The authors mention some problems the study could have faced, including low adherence to the therapies, length of the study, and also it being an open-label study where the patients knew what they were taking.

With how common smoking is, studies revolving around smoking cessation is important. While this study may have some flaws, it illustrates that all these three therapies have an effect on motivating smokers to quit smoking. If the non-prescription patch is as effective as the other two prescription therapies, it can greatly influence some smokers’ decisions about trying to quit smoking. The patch will be a lot cheaper and accessible, thus be able to reach a larger population. A big problem the study pointed out that is also common in other smoking cessation studies is the somewhat low adherence, rates being a little below 50%. In the smokers that did adhere, results could be seen from the lower amount of cigarettes they smoked or even completely quitting. Quitting smoking will greatly improve the health of a person, and these pharmacotherapies can help one with the process.

JAMA. 2016;315(4):371-379.

Repeated Administration of an Acetylcholinesterase Inhibitor Attenuates Nicotine Taking in Rats and Smoking Behavior in Human Smokers

A study was done on rats to test the effectiveness of acetylcholinesterase inhibitors for smoking cessation therapy. This involved training rats to self administer 0.03 mg/kg per 0.59 mL doses of nicotine intravenously on a fixed-ratio-5 schedule of reinforcement. This means the rats were given positive reinforcement every 5 times they administered the nicotine themselves during this training. Once they were self-administering nicotine consistently, they were given one of two acetylcholinesterase inhibitors, 3.0 mg/kg of donepezil or 5.0 mg/kg of galantamine. They were given one of the two medications once daily for ten days, each day right before their daily nicotine self-administration sessions. Each day these medications were given to the rats, the rats’ self-administration of nicotine clearly decreased based on observation. Researchers knew this was not due to malaise-like adverse effects of the drugs because repeated administration of the drugs did not affect sucrose self-administration or food intake for the rats.

A study was also done on humans to test whether acetylcholinesterase inhibitors were effective for smoking cessation. For one week, a group of smokers were given either 8.0 mg of galantamine or a placebo daily. For the second week, without a break in between the two weeks, the same individuals were given 16.0 mg of the same medication or the placebo daily. This helped prove galantamine plays a role in smoking cessation therapy because the smoking rate and smoking satisfaction of those taking it decreased over these two weeks compared to those taking the placebo. Overall, I found this article very interesting, and I am curious to see if this class of medications actually begins to be used for smoking cessation therapy. I am also wondering if individuals will need to be on as strong of doses as those who are taking the same class medications for disease states such as Alzheimer’s.

Transl. Psychiatry. 2016;713(6):1-8.

http://www.nature.com/tp/journal/v6/n1/full/tp2015209a.html

 

Mailing Nicotine Patches to Aid in Smoking Cessation

This past July, a randomized clinical trial just concluded after nearly three years of study which evaluated whether or not mailing nicotine patches to adult smokers without behavioral support would help increase quit success rates. The trial included 2,093 individuals who smoked more than 10 cigarettes daily. Individuals who were interested and eligible to participate were designated to either an experimental group that received a 5-week supply of nicotine patches by mail or a control group that offered any other form of intervention. The individuals were followed-up with by the investigators at 8 weeks and at 6 months.

After the study, self-reported assistance rates were significantly higher for those in the experimental group who received nicotine replacement therapy via mail compared to those in the control group. Overall, the trial provided evidence that mailed nicotine patches were effective to promote successful tobacco cessation. However, because of the lack of biochemical validation for all the individuals in the study, the strength of these findings is somewhat tempered.

JAMA Intern Med. Published online January 25, 2016.

Link to article

This article came of interest to me because it brought to my attention how increased access to healthcare can lead to an overall healthier lifestyle. Like with available mailing services, more and more patients will be able to obtain the healthcare that they need as pharmacists move to provider status. I personally am looking forward to the future of healthcare that leads to a better well-being amongst the community.