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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.

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 data supports the idea that Sleep Management for Nicotine Addiction is an effective treatment?

The available research shows that addressing sleep problems can help improve smoking cessation outcomes. Sleep issues are common during nicotine withdrawal and can make quitting harder. By focusing on sleep, treatments like dual orexin receptor antagonists (DORAs) can reduce withdrawal symptoms and nicotine cravings, making it easier to quit smoking. This approach is promising because it targets both sleep and addiction, unlike other treatments that might worsen sleep problems. Additionally, studies show that nicotine replacement can improve sleep quality during withdrawal, which supports the idea that managing sleep can aid in quitting smoking. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Sleep Management for Nicotine Addiction?

Research suggests that addressing sleep problems can improve smoking cessation outcomes, as sleep disturbances are common during nicotine withdrawal and can hinder quitting efforts. Additionally, treatments that improve sleep quality, such as dual orexin receptor antagonists (DORAs), have shown potential in reducing nicotine cravings and withdrawal symptoms, supporting the idea that sleep management could be an effective adjunctive treatment for nicotine addiction. ^{1 2 3 4 5}

What safety data exists for sleep management in nicotine addiction treatment?

The safety data for sleep management in nicotine addiction treatment includes the use of dual orexin receptor antagonists (DORAs) like suvorexant and lemborexant, which have a milder adverse event profile compared to previous insomnia treatments. Nicotine replacement therapy has been shown to improve sleep quality post-cessation, despite withdrawal-related sleep disturbances. Studies have also compared the effects of different nicotine patch durations on sleep, indicating that nicotine presence or withdrawal can affect sleep patterns. ^{1 5 6 7 8}

Is the sleep management treatment for nicotine addiction safe for humans?

Dual orexin receptor antagonists (DORAs), which may be used to help with sleep during smoking cessation, have a milder side effect profile compared to other insomnia treatments, suggesting they are generally safe. Nicotine replacement therapies, like patches, can improve sleep quality during withdrawal, indicating they are also safe for use. ^{1 5 6 7 8}

Is the drug used in the Sleep Management for Nicotine Addiction trial a promising treatment?

Yes, the drug used in the trial, which targets sleep issues with dual orexin receptor antagonists (DORAs), is promising. It helps reduce nicotine cravings and withdrawal difficulties by improving sleep, which is often disturbed during smoking cessation. This approach could make it easier for people to quit smoking and stay smoke-free. ^{1 3 5 8 9}

How does the drug used in the Sleep Management for Nicotine Addiction trial differ from other treatments for nicotine addiction?

This treatment is unique because it uses dual orexin receptor antagonists (DORAs) to address sleep problems that worsen during nicotine withdrawal, unlike other smoking cessation drugs that can exacerbate sleep issues. By targeting the orexin system, which regulates the sleep-wake cycle, DORAs may help reduce withdrawal symptoms and nicotine cravings, offering a novel approach to support smoking cessation. ^{1 3 5 8 9}

Research Team

Karen Cropsey, Psy.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Able to read and speak English

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Sleep as a Target for Optimized Response to Smoking Cessation Treatment. [2020]

3. England 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Narcolepsy with cataplexy masked by the use of nicotine. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Tobacco withdrawal and nicotine replacement influence objective measures of sleep. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep effects of a 24-h versus a 16-h nicotine patch: a polysomnographic study during smoking cessation. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

The influence of 8 and 16 mg nicotine patches on sleep in healthy non-smokers. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Cigarette smoking and sleep disturbance]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep changes in smokers before, during and 3 months after nicotine withdrawal. [2016]