Clinical trial NCT02941718: Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Official title: Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nicotine Dependence
Keywords: Smoking
Smoking cessation
Nicotine
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This study will address this conceptual and empirical gap by conducting a 15-week proof-of-concept study to determine whether standard smoking cessation treatment can be optimized with a multi-metric sleep advancement counseling intervention.

Detailed description: The current study is a randomized controlled trial designed to test the impact and efficacy of a sleep advancement counseling (SAC) protocol in response to standard nicotine dependence treatment (behavioral counseling + varenicline) in a sample of 90 treatment seeking smokers from the greater Newark city/Newcastle county area. Following eligibility assessment, which include an overnight polysomnography (sleep study), 90 eligible and consenting treatment-seeking smokers will be randomized to either the experimental smoking cessation + SAC (N=60), or the control, smoking cessation + general health education (GHE) alone (N=30) condition. Participants will complete six in-person counseling sessions over a 15-week treatment period (wks 1, 3, 4,7,11,15) As part of the smoking cessation treatment protocol, eligible participants will receive 12 weeks of FDA-approved smoking cessation medication, Varenicline, during week 3-15. An end of treatment (week 15) and a 12-week follow-up (week 27) assessment will be conducted in-person to allow for the objective assessment of smoking status and cardiovascular markers.

Eligibility criteria: Inclusion Criteria:

1. adults (\>18 -65) who smoke at least 8 cigarettes/day;
2. Report wanting to quit smoking in the next month
3. No current diagnosis of psychosis or bipolar disorder.
4. able to communicate in English and provide written informed consent for study procedures
5. able to use varenicline safely.
6. No current diagnosis of any sleep disorders (except of insomnia)
7. Have access to a smart phone or tablet own the home

Exclusion Criteria:

1. Current enrollment or plans to enroll in another smoking cessation program and/or use a nicotine substitute (e.g., e-cigarettes) in the next 6 months,
2. Current use of illicit drugs (e.g., cocaine, opioids, or methamphetamines),
3. Current alcohol consumption that exceeds 14 standard alcoholic drinks/week for men, and more than 7 for women.
4. Current use or recent discontinuation (within last 14 days) of anti-psychotic and/or bipolar disorder medications,
5. Women who are pregnant, planning a pregnancy within the next 6 months, or lactating,
6. Uncontrolled hypertension (SBP \>160 or DBP \>100)
7. Current sleep disorder or use of sleep medication
8. History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval),
9. Any current suicidal ideation, or self-reported suicide attempt
10. Current or past diagnosis of psychotic or bipolar disorder
11. Currently working night/rotating shift.
12. Allergy to Varenicline
13. Unstable or untreated moderate or severe depression as assessed by the center for epidemiology studies depression scale 16 for higher.

Primary outcomes:
measure: Carbon Monoxide Level
timeFrame: 15-week
Secondary outcomes:
measure: Objective Sleep Duration and Timing
timeFrame: 15-weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Freda Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson F, Malone SK, Lozano A, Grandner MA, Hanlon AL. Smoking, Screen-Based Sedentary Behavior, and Diet Associated with Habitual Sleep Duration and Chronotype: Data from the UK Biobank. Ann Behav Med. 2016 Oct;50(5):715-726. doi: 10.1007/s12160-016-9797-5.
citation: Malone SK, Patterson F, Lu Y, Lozano A, Hanlon A. Ethnic differences in sleep duration and morning-evening type in a population sample. Chronobiol Int. 2016;33(1):10-21. doi: 10.3109/07420528.2015.1107729. Epub 2015 Dec 10.
citation: Patterson F, Jepson C, Loughead J, Perkins K, Strasser AA, Siegel S, Frey J, Gur R, Lerman C. Working memory deficits predict short-term smoking resumption following brief abstinence. Drug Alcohol Depend. 2010 Jan 1;106(1):61-4. doi: 10.1016/j.drugalcdep.2009.07.020. Epub 2009 Sep 5.
citation: Patterson F, Jepson C, Strasser AA, Loughead J, Perkins KA, Gur RC, Frey JM, Siegel S, Lerman C. Varenicline improves mood and cognition during smoking abstinence. Biol Psychiatry. 2009 Jan 15;65(2):144-9. doi: 10.1016/j.biopsych.2008.08.028. Epub 2008 Oct 8.
citation: Patterson F, Kerrin K, Wileyto EP, Lerman C. Increase in anger symptoms after smoking cessation predicts relapse. Drug Alcohol Depend. 2008 May 1;95(1-2):173-6. doi: 10.1016/j.drugalcdep.2008.01.013. Epub 2008 Mar 6.