Sleep Management for Nicotine Addiction

Overseen By Melinda Clarke, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Psychiatric, Pain, Sleep medications

Disqualifiers: Pregnancy, Tobacco use, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep patterns affect smoking habits, cravings, and withdrawal symptoms, focusing on Black and white individuals. Participants will either extend their sleep to 10 hours (sleep extension condition) or restrict it to 4 hours (sleep restriction condition) to observe the impact on smoking behavior. It targets daily smokers or non-smokers living in Alabama who speak English and identify as non-Hispanic Black or white. The goal is to determine if sleep and racial differences influence smoking dependence and quitting success. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on sleep and smoking behavior.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but if you are taking psychiatric medications, pain medications (like opioids), or sleep medications (such as Ambien, trazodone, melatonin, or CBD products), you cannot participate in Sub-study 3.

Will I have to stop taking my current medications?

If you are taking psychiatric medications, pain medications like opioids, or sleep medications such as Ambien, trazodone, melatonin pills, or CBD products, you will need to stop taking them to participate in the trial.

What prior data suggests that these sleep management techniques are safe for nicotine addiction?

Research shows that sleep significantly affects nicotine addiction experiences. People often struggle with sleep when trying to quit smoking. However, better sleep might aid in maintaining a smoke-free life. Although specific information on how limiting sleep affects quitting is limited, similar studies suggest that sleep problems can hinder the quitting process.

Researchers are exploring both increasing and limiting sleep to determine their effects on smoking cessation. While detailed safety information on these sleep changes is scarce, sleep studies generally consider them safe, suggesting most people can handle them well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using sleep management strategies for nicotine addiction because they offer a novel approach that differs from traditional methods like nicotine replacement therapies, medications, or behavioral counseling. This trial explores two distinctive sleep interventions: a sleep extension condition allowing 10 hours in bed and a sleep restriction condition with only 4 hours in bed. By manipulating sleep patterns, researchers hope to uncover how sleep duration can impact cravings and withdrawal symptoms, potentially offering a non-pharmacological and simple lifestyle modification to aid in smoking cessation. If successful, these strategies could provide an accessible and cost-effective way to complement existing treatments, making it easier for individuals to quit smoking.

What evidence suggests that this trial's treatments could be effective for nicotine addiction?

Research shows that sleep plays a crucial role in nicotine addiction and smoking habits. Studies have found that poor sleep increases nicotine dependence, making quitting more difficult. In this trial, participants in the sleep extension group, who will have 10 hours in bed, might experience reduced cravings and improved mood, aiding in smoking cessation. Conversely, participants in the sleep restriction group, with only 4 hours in bed, may experience increased smoking and stronger cravings. Less sleep can hinder quitting by increasing irritability and withdrawal symptoms. These findings suggest that better sleep could be a useful strategy for those trying to quit smoking. ^{2 5 6 7 8}

Who Is on the Research Team?

Karen Cropsey, Psy.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can read and speak English, identify as non-Hispanic African American or white, and live in Alabama. It's for daily smokers (5+ cigarettes a day for the past year) or non-smokers (less than 100 cigarettes lifetime, none in the last year).

Inclusion Criteria

Sub-Study 1

I am a daily smoker or I have never smoked more than 100 cigarettes in my life.

Non-Hispanic African American (Black) or non-Hispanic white race

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete self-report questionnaires and objective measures of sleep quality and timing

4 weeks

1 visit (in-person), multiple assessments (virtual)

Intervention

Participants undergo sleep restriction (4 hours time in bed) or sleep extension (10 hours time in bed) to assess effects on craving and withdrawal

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in smoking behavior, sleep quality, and withdrawal symptoms

6 months

Monthly assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Sleep extension condition
• Sleep restriction condition

Trial Overview

The study examines how sleep patterns affect cigarette cravings and withdrawal by comparing two conditions: extending participants' sleep time versus restricting it. The focus is on racial differences in these effects.

How Is the Trial Designed?

Group I: Sleep Restriction Experimental Treatment 1 Intervention

4 hours time in bed (1 am to 5 am)

Group II: Sleep Extension Experimental Treatment 1 Intervention

10 hours time in bed (10 pm to 8 am)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Published Research Related to This Trial

In a study of 66 healthy non-smokers aged 20-25, the application of a 16 mg nicotine patch during the night led to significant reductions in sleep duration and efficiency, along with increased wake time, indicating that nicotine can disrupt sleep patterns.

The study found that nicotine caused insomnia-like symptoms without affecting sleep-related withdrawal symptoms after 13 hours, suggesting that nicotine presence, rather than withdrawal, is responsible for these sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of 8 and 16 mg nicotine patches on sleep in healthy non-smokers. Jaehne, A., Unbehaun, T., Feige, B., et al.[2018]

Despite a national decline in tobacco use to 15.1%, high-risk, low-income populations still show smoking rates as high as 50%, highlighting the need for more effective smoking cessation strategies.

This review suggests that addressing sleep disturbances, which are common during nicotine withdrawal, could enhance the effectiveness of existing smoking cessation treatments, making sleep therapy a promising adjunctive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep as a Target for Optimized Response to Smoking Cessation Treatment. Patterson, F., Grandner, MA., Malone, SK., et al.[2020]

In a study involving 20 heavy smokers, the 24-hour nicotine patch was found to significantly improve sleep quality compared to the 16-hour patch, as indicated by fewer microarousals and increased slow wave sleep.

The 24-hour patch also enhanced REM sleep characteristics, suggesting it may be more effective in reducing sleep disturbances associated with tobacco withdrawal during a short smoking cessation period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep effects of a 24-h versus a 16-h nicotine patch: a polysomnographic study during smoking cessation. Staner, L., Luthringer, R., Dupont, C., et al.[2017]

Chronic use of cigarettes and nicotine patches can mask symptoms of narcolepsy with cataplexy, suggesting that nicotine may have a role in symptom management.

This case contributes to existing evidence that nicotine can alleviate symptoms of narcolepsy, as previously noted in other reports involving smokers and adolescents using nicotine patches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narcolepsy with cataplexy masked by the use of nicotine. Ebben, MR., Krieger, AC.[2021]

Current smoking cessation medications often worsen sleep problems, which can hinder quitting success, highlighting the need for new approaches.

Dual orexin receptor antagonists (DORAs) like suvorexant and lemborexant may improve smoking cessation outcomes by alleviating withdrawal symptoms and reducing cravings, while also having a better safety profile than traditional insomnia treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Orexin Receptor Antagonists (DORAs) as an Adjunct Treatment for Smoking Cessation. Hamidovic, A.[2022]

Tobacco withdrawal significantly increases sleep disturbances, specifically sleep fragmentation, in dependent smokers, as shown in a clinical trial with 34 participants monitored for sleep quality before and after quitting.

Nicotine replacement therapy, using patches, improves sleep quality post-cessation by reducing sleep fragmentation and enhancing deeper sleep stages (Stage 3 and Stage 4).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco withdrawal and nicotine replacement influence objective measures of sleep. Wetter, DW., Fiore, MC., Baker, TB., et al.[2019]

In a study of 20 dependent smokers, the 24-hour nicotine patch was found to be more effective than the 16-hour patch in reducing morning smoking urges and enhancing sleep quality, particularly by increasing slow wave sleep.

The 24-hour patch not only alleviated smoking urges more effectively but also improved morning alertness, suggesting that continuous nicotine delivery does not disrupt sleep but may actually enhance restorative sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of a 24-hour nicotine patch and a 16-hour nicotine patch on smoking urges and sleep. Aubin, HJ., Luthringer, R., Demazières, A., et al.[2015]

Sleep disturbances are common in smokers and can complicate smoking cessation efforts, leading to increased relapse rates; this is due to nicotine's effects on sleep and the withdrawal symptoms associated with quitting.

Smoking cessation programs should address sleep issues, as improving sleep quality may help individuals quit smoking more successfully and reduce the risk of cardiovascular and cerebrovascular problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cigarette smoking and sleep disturbance]. Underner, M., Paquereau, J., Meurice, JC.[2015]

In a study of 33 smokers, sleep disturbances were observed during nicotine withdrawal, with increased wake time and arousal index compared to when they were smoking, indicating that withdrawal negatively impacts sleep quality.

Smokers who relapsed after quitting exhibited more severe nicotine dependence and experienced greater sleep impairments, including reduced REM sleep and longer REM latency, suggesting that sleep issues during withdrawal may contribute to a higher risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep changes in smokers before, during and 3 months after nicotine withdrawal. Jaehne, A., Unbehaun, T., Feige, B., et al.[2016]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6329404/

Sleep as a Target for Optimized Response to Smoking ...

Results showed a significantly increased percentage of wake time after sleep onset and night-time arousal in the first 24–36 h of quitting; no significant ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S108707922400145X

Conditions of sleep restoration after smoking cessation

This review aims to assess the impact of smoking cessation on sleep by taking into account objective and subjective methods of assessment.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11533092/

The association between nicotine dependence and sleep ...

Increased nicotine dependence and anxiety are independently associated with poor sleep quality. The findings support smoking cessation efforts.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01277887

Smoking Cessation for Smokers With Sleep Problems | ...

This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation. The study is designed to find ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04265339

The Interplay Between Addiction to Tobacco Smoking and ...

Results of this study will provide novel insight on the role of sleep in nicotine addiction. Experiments will show how reduced quality of sleep may result from ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5443250/

Sleep Disturbance During Smoking Cessation: Withdrawal ...

Our data suggest that individuals who received active smoking cessation treatment experienced greater increases in sleep disturbance than those who received ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11212010/

Exploring the relationship between smoking and poor sleep ...

Dose-response analyses revealed that the odds of these sleep outcomes increased with higher smoking levels. Conclusion. Smoking is significantly ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590142723000253

Effects of smoking on sleep architecture and ventilatory ...

In long-term smoking cessation, studies have shown a reduction in sleep latency and slow-wave sleep, while the percentage of REM sleep is ...