NUR 602 Module 9 Final Project Example

Final Project: Varenicline, a Patch and a Plan for Mood: Treating Tobacco Dependence in a 52-Year-Old Woman With a History of Depression

[Student Name]

Southern New Hampshire University

NUR 602: Advanced Pharmacology Across the Life Span

Final Project

[Instructor Name]

[Date]

The organization, setting and figures below are a composite written as a model document. No real employer, client, colleague or patient is described.

Final Project: Varenicline, a Patch and a Plan for Mood: Treating Tobacco Dependence in a 52-Year-Old Woman With a History of Depression

No other single habit kills as many Americans as cigarette smoking, and adults with depression smoke more and succeed at quitting less often than other adults. For years, the most effective cessation drug carried a warning that discouraged its use in exactly these patients. This final project builds a complete pharmacotherapy plan for a woman with a history of depression who wants to quit. It argues that varenicline, combined with a nicotine patch and continued beyond 12 weeks, is the most effective and appropriately safe choice for her, and that the plan must also address her mood, her other drug levels and her cancer risk.

Patient Assessment

Denise is 52, an office manager, married with two adult children. She has smoked a pack a day since age 22, giving her 30 pack-years, and smokes her first cigarette within five minutes of waking, which signals high dependence. She has tried to quit three times. On the last attempt, two years ago, bupropion SR caused insomnia and jitteriness, and she stopped it after ten days and resumed smoking within a month. She has major depressive disorder, with one severe episode at 44, now in remission for six years on escitalopram 10 mg daily. Her PHQ-9 score today is 4. She drinks four to five cups of coffee daily and one glass of wine on weekends and has no history of seizures or eating disorders.

Her blood pressure is 126/82, her body mass index is 27 and her creatinine is 0.8 mg/dL. She has no known cardiovascular disease. She is ready to set a quit date within the month but is afraid that a quit-smoking drug will make her depressed again, a concern she read about online.

Goals

The primary goal is continuous abstinence from smoking from her quit date, confirmed at 12 and 24 weeks. Secondary goals are a PHQ-9 score that stays below 10 throughout, manageable withdrawal symptoms and weight gain under 5 kg at six months. She has also said she wants to stop coughing in the morning and to be able to hold her new granddaughter without smelling of smoke.

Evidence for the Options

The question Denise is asking was the reason EAGLES was run. Its 8,144 participants, roughly half of them with a psychiatric diagnosis such as depression, spent 12 weeks on one of four arms: varenicline, bupropion, a nicotine patch or placebo. Among those with a psychiatric diagnosis, the share reporting a moderate or severe neuropsychiatric event was 6.5% on varenicline against 4.9% on placebo, with bupropion at 6.7% and the patch at 5.2%, and no active drug differed significantly from placebo. Varenicline produced higher abstinence rates than bupropion or the patch in both cohorts (Anthenelli et al., 2016). A follow-up analysis of the same participants found no increase in major cardiovascular events with any of the three drugs (Benowitz et al., 2018).

The American Thoracic Society guideline builds on this evidence. It recommends varenicline over the nicotine patch and over bupropion, recommends varenicline over the patch in patients with psychiatric conditions specifically, suggests adding a nicotine patch to varenicline rather than using varenicline alone and recommends extending treatment beyond the standard 12 weeks (Leone et al., 2020). Those recommendations fit Denise closely.

Drug Selection and Regimen

Varenicline is a partial agonist at the alpha-4 beta-2 nicotinic acetylcholine receptor. It stimulates the receptor enough to ease craving and withdrawal while blocking nicotine from binding fully, so a cigarette smoked during treatment is less rewarding. It is cleared almost entirely by the kidneys unchanged and has no meaningful effect on liver enzymes, so it does not interact with escitalopram. Bupropion is a poorer choice for her because it caused insomnia and agitation before and because the evidence shows it is less effective. Adding the patch provides steady nicotine replacement during the first weeks, when her morning craving is strongest.

The regimen is set out in Table 1. She will set a quit date on day 8, though she may choose any day between day 8 and day 35 if she prefers to let the drug reduce her smoking first.

Table 1. Varenicline and Nicotine Patch Schedule

Note. Varenicline titration from the product labeling; extended duration and combination with the patch follow Leone et al. (2020). A dose reduction applies if creatinine clearance falls below 30 mL/min.

Safety, Adverse Effects and Interactions

Nausea is the most common adverse effect of varenicline and eases when each tablet follows a meal and is swallowed with plenty of water; if it persists, the dose can be lowered to 0.5 mg twice daily. Vivid dreams and insomnia are also common, and the evening dose can be taken with dinner rather than at bedtime. Skin irritation from the patch is managed by rotating sites, and she can remove the patch at night if it disturbs her sleep.

One interaction is caused by quitting rather than by the drug. The tar in cigarette smoke speeds up CYP1A2, the liver enzyme that clears most of the caffeine she drinks. Once she stops, the enzyme slows back to its baseline over about a week, so the same four or five cups can leave her with roughly twice the caffeine in her blood. Restlessness, palpitations and poor sleep in the second week could be mistaken for withdrawal, anxiety or a drug effect. She should reduce her coffee by about half in the week of her quit date. Escitalopram is not mainly metabolized by CYP1A2, so its dose should not need to change.

Mood Safety Plan

Her fear deserves a clear answer and a plan. The best evidence shows that varenicline did not raise the risk of serious psychiatric effects in people with depression compared with placebo (Anthenelli et al., 2016). A meta-analysis found that anxiety, depression and stress decreased in people who quit smoking compared with those who continued, with a standardized mean difference of -0.25 for depression (Taylor et al., 2014). Quitting is therefore more likely to help her mood than harm it. Still, early withdrawal can lower mood for a few weeks. She will complete a PHQ-9 at each visit, and she and her husband will be told to call the same day for low mood lasting more than two days, agitation or any thoughts of self-harm. Her escitalopram continues unchanged.

Counseling and Support

Medication works better with behavioral support. Denise will be referred to the state quitline at 1-800-QUIT-NOW, which offers free telephone coaching, and given a plan for her three highest-risk situations: the first cigarette with morning coffee, the drive home from work and weekend wine. For each, she has chosen a replacement, such as taking her coffee to a different room, keeping sugar-free gum in the car and holding her glass in her other hand. Her husband, who does not smoke, has agreed to help her remove ashtrays and lighters before the quit date.

Monitoring and Follow-Up

Contact is scheduled at week 1 by phone, then in person at weeks 2, 4, 8, 12 and 24. Each visit will record cigarettes smoked, a PHQ-9 score, nausea and sleep, weight and blood pressure. Exhaled carbon monoxide will confirm abstinence at week 12. A lapse is not treated as failure; the plan is to continue the medicine, review what triggered the lapse and adjust support. If she relapses fully, the next attempt can start again with the same regimen, which remains effective on repeat use.

Health Promotion Beyond Quitting

Denise qualifies for annual lung cancer screening with low-dose computed tomography, because her age and her 30 pack-years both clear the thresholds in the current US Preventive Services Task Force statement, which covers current smokers and recent quitters in their fifties, sixties and seventies (US Preventive Services Task Force, 2021). A shared decision-making visit will be scheduled, since screening carries risks of false positives and overdiagnosis as well as benefit. Her quit attempt is also a good moment to review her cardiovascular risk and to encourage regular activity, which can limit weight gain.

Limitations

The evidence has limits. EAGLES excluded people with unstable psychiatric illness and current substance use disorders, so its safety findings apply most confidently to patients like Denise, whose depression is stable. Most cessation trials report outcomes to 24 weeks, while relapse can occur much later. The caffeine interaction is well described pharmacologically but has been studied less often as an outcome.

Conclusion

For Denise, varenicline with a nicotine patch, extended to 24 weeks and paired with quitline coaching, offers the best chance of quitting, and the strongest evidence shows it is safe for someone with stable depression. The plan anticipates her rising caffeine levels, watches her mood with a validated measure and uses her quit attempt as an entry point to lung cancer screening. It is a plan built for her history, not only for her diagnosis.

References

Anthenelli, R. M., Benowitz, N. L., West, R., St Aubin, L., McRae, T., Lawrence, D., Ascher, J., Russ, C., Krishen, A., & Evins, A. E. (2016). Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): A double-blind, randomised, placebo-controlled clinical trial. The Lancet, 387(10037), 2507-2520. https://doi.org/10.1016/S0140-6736(16)30272-0

Benowitz, N. L., Pipe, A., West, R., Hays, J. T., Tonstad, S., McRae, T., Lawrence, D., St Aubin, L., & Anthenelli, R. M. (2018). Cardiovascular safety of varenicline, bupropion, and nicotine patch in smokers: A randomized clinical trial. JAMA Internal Medicine, 178(5), 622-631. https://doi.org/10.1001/jamainternmed.2018.0397

Leone, F. T., Zhang, Y., Evers-Casey, S., Evins, A. E., Eakin, M. N., Fathi, J., Fennig, K., Folan, P., Galiatsatos, P., Gogineni, H., Kantrow, S., Kathuria, H., Lamphere, T., Neptune, E., Pacheco, M. C., Pakhale, S., Prezant, D., Sachs, D. P. L., Toll, B., . . . Farber, H. J. (2020). Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society clinical practice guideline. American Journal of Respiratory and Critical Care Medicine, 202(2), e5-e31. https://doi.org/10.1164/rccm.202005-1982ST

Taylor, G., McNeill, A., Girling, A., Farley, A., Lindson-Hawley, N., & Aveyard, P. (2014). Change in mental health after smoking cessation: Systematic review and meta-analysis. BMJ, 348, Article g1151. https://doi.org/10.1136/bmj.g1151

US Preventive Services Task Force. (2021). Screening for lung cancer: US Preventive Services Task Force recommendation statement. JAMA, 325(10), 962-970. https://doi.org/10.1001/jama.2021.1117