Nicotine as a Treatment for the Alleviation of Depression Symptoms, Capstone Project Example

Abstract

Background: Nicotine is most commonly associated with cigarette addiction, but research has shown that it could be used to control the symptoms of mental disorders as well. Cigarette addiction results from nicotine’s interaction with chemical receptors in the brain, indicating that there are biological consequences for this chemical’s use. This creates brain responses that can confer therapeutic benefit.

Research Question: Can nicotine reduce depression symptoms in patients with diagnosed chronic depression?

Hypothesis: I hypothesize that depression treatment using nicotine will have a dose-dependent response in depressed patients.

Materials and Methods: The study includes two treatment groups and one control group, with 15 patients in each of the three study arms, total number of participants are 45. One experimental group will be provided with a 15 mg nicotine patch and the other will be provided with a 30 mg nicotine patch. The control group will receive no patch. All study participants will be asked to cease their depression medication and will be instead provided with 15 or 30 mg nicotine patch.

Results: It is expected that the individuals that using the nicotine patch will experience a greater reduction depression symptoms versus individuals in the control group.

Study Proposal

Significance of Research

Currently, there are not many effective treatments for depression (Powledge 2004; Berenstein et al. 2011; Benowitz et al. 2010; Cohen et al. 2005; Dewey et al. 1998). All current medications interfere with brain functionality in a manner that can contribute to severe side effects, such as loss of libido and reduced emotionality (Cohen et al. 2005). The use of nicotine to quell depression systems would therefore serve as a cost effective and healthier treatment because the symptoms that nicotine users experience tend to be less severe than those experienced by medicated depression patients.

Rationale

Nicotine is the chemical in cigarettes that is responsible for an addictive effect. However, the complex chemical interactions that produce a sense of addiction also have the potential to interact with receptors in the brain that regulate depression. Studies have shown that nicotine has the potential to reduce symptoms associated with mental disorders including Alzheimer’s disease, Parkinson disease, anxiety, schizophrenia, attention deficit hyperactivity disorder and even pain and obesity symptoms can be alleviated using this chemical (Powledge 2004; Berenstein et al. 2011; Benowitz et al. 2010; Cohen et al. 2005; Dewey et al. 1998). Since many of the biochemical interactions that contribute to symptoms of these mental disorders overlap with those that contribute to depression symptoms, it is reasonable that nicotine could be used to help alleviate depression symptoms as well.

Research shows that nicotine has many practical uses in situations that are not conventionally considered. Conducting additional research is needed to determine whether it would be reasonable to use nicotine to treat mental depression. Since nicotine is readily accessible by members of the population, it would be beneficial to determine if this cost effective and readily available treatment has the potential to contribute to real improvement among individuals who have been diagnosed with depression. Many of the studies previously conducted can be classified as phase I trials for use of the drug, so it would be beneficial to extend these understandings to additional applications (Powledge 2004). The objective of this study is to determine the symptom alleviating ability of nicotine and to determine whether this chemical has the ability to treat depression symptoms. It is hypothesized that nicotine will effectively reduce depression symptoms in patients that are not medicated through other means.

Methods

Participants will be recruited using random selection procedures through social media platforms. Inclusion criteria for participants to be eligible for this study are: all participants are 18 years or older; have been formally diagnosed with depression by their physician; have no other mental disorders with overlapping symptoms; and are currently only taking medication, not therapy, to treat the disorder. Exclusion criteria will include individuals who are currently smokers or have a history of smoking, regardless of the quantity of cigarettes regularly or irregularly consumed. Participants will only be accepted to the study if they have general health insurance coverage so they can be treated for nicotine symptoms if necessary.  All informed consent documentation will be written at an 8th grade level to ensure that all participants are able to readily understand the information it contains. A total of 45 patients will be separated into two treatment groups and one control group, with 15 patients in each of the three study arms. One experimental group will be provided with a 15 mg nicotine patch and the other will be provided with a 30 mg nicotine patch. The control group will be provided with a placebo patch that contains no medication. All participants will be asked to cease their depression medication during the duration of the trial. Participants will be asked to report any adverse effects from the lack of depression medication or from the patch immediately in order to ensure their continued health. Follow up to determine the status of disease symptoms and possible side effects of nicotine use will occur one day following the application of the patch; three days following the application; one week, and two weeks. After the evaluation at two weeks, the participants will be asked to cease use of the patch for purposes of the study.

Data Analysis

Qualitative analysis will be used to determine the specific symptoms that were reduced as a consequence of the use of nicotine. The DSM-V diagnostic manual will be used to assess the depression symptoms exhibited by the participants prior to the initiation of the trial. They will be asked to self-diagnose their symptoms and rate their severity on a scale of 1 to 10. This assessment will be repeated during the follow up period and analysis will be conducted to determine the differences that occurred between baseline and follow up. The same test will be provided in both instances to ensure consistency of data collection.

A quantitative analysis will also be conducted to determine an enhanced understanding of the study population being examined. Descriptive statistics to determine the central tendency of symptom severity and a Z test will be used to determine the statistical significance of the portion of the study population that benefitted from use of the nicotine patch in terms of their depression symptoms.

IRB Approval and Safety Precautions

IRB approval will be sought prior to conducting the study. All participants will be required to sign informed consent documentation to take part in the study. This study involves human participants that could potentially suffer adverse health effects through nicotine use. Patients will be asked whether they have suffered an allergic reaction from the use of a nicotine patch previously before the beginning of the experiment. Patients who have suffered from an adverse reaction will be advised to forgo participating in the study. Furthermore, patients will be informed that they are able to discontinue involvement in experimentation at any time. Subjects will not be responsible for any of the costs or materials. Lastly, it is important to consult a medical professional to determine how this project could be conducted safely and to ensure that any warning signs related to nicotine use are detected in early stages prior before its use becomes hazardous to the participant.

Budget Statement and Materials

The following items are required for the study:

• A total of $750 is being requested for this study, which is expected to last for two weeks
• $350 is needed to obtain 7 containers of 30 mg nicotine patches and an additional $350 is needed to obtain 7 containers of 15 mg nicotine patches
• The remaining $50 is needed to make paper copies of relevant surveys and informed consent documentation
• 45 copies will be needed to conduct the baseline assessment, and 45 copies will be needed for each of the additional follow up sessions, at one day following the application of the patch, three days following the application, one week later, and two weeks later for the final assessment, for a total of 225 copies that have 2 pages each
• Additional materials that will be used for the experiment include the DSM-V diagnostic manual (available online for free) for diagnosis of depression symptoms and to determine whether these symptoms are improving
• Microsoft Excel will also be utilized to conduct the quantitative analysis

Budget Justification

Budget expenditures will be used to acquire items that are need to carry out the experimentation. Nicotine patches cost approximately $50 per box at a majority of local drugstores, including CVS and Duane Reade. The average copy costs 10 cents per page; this figure includes the need to produce survey and informed consent documentation for approximately 45 people. At each point in the trial, two double sided pages of information will be needed, requiring a total of 450 pages in copies to be made. An extra $5 is available to account for miscalculation of price and to include tax on these copies. Thus, it is necessary to utilize the requested $750 to properly carry out this experiment.

Bibliography

Bernstein SL, Bijur P, Cooperman N, Jearld S, Arnsten JH, Moadel A, Gallagher EJ.

A randomized trial of a multicomponent cessation strategy for emergency department smokers. Academy of Emergency Medicine 18(6):575-83.

Benowitz, N.L. 2010. Nicotine Addiction. N Engl J Med. 362(24): 2295–2303.

Cohen, C., Kodas, E., Griebel G. 2005. B1 receptor antagonists for the treatment of nicotine addiction”. Pharmacology Biochemistry and Behavior 81(2): 387–395.

Dewey, S.L., Brodie, S.D., Gerasimov, M., Horan, B., Gardner, E.L., Ashby, C.R. 1998. A pharmacologic strategy for the treatment of nicotine addiction. Synapse 31(1).

Powledge TM. 2004. Nicotine as Therapy.  PLoS Biol. 2(11): e404.

Sanberg, P.R., Silver, A.A., Shytle, R.D., Philipp, M.K., Cahill, D.W., Fogelson, H.M.,