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Examination of Sleep, Smoking Cessation, and Cardiovascular Health

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sleep Advancement Counseling
General Health Information
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking, Smoking cessation, Nicotine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep Advancement Counseling

General Health Intervention

Arm Description

Participants will receive a 15-week intervention targeting smoking cessation and sleep counseling intervention. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. Sleep counseling components in the form of CBT for insomnia will be given as part of the smoking cessation counseling.

Participants will receive a 15-week intervention targeting smoking cessation and general health information. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. The general health information counseling will be given as part of the smoking cessation counseling and topics include diet, physical activity, oral health, cancer screening and skin protection.

Outcomes

Primary Outcome Measures

Carbon Monoxide Level
% of participants with a CO level of 10 or fewer parts per million (ppm)

Secondary Outcome Measures

Objective Sleep Duration and Timing
Will be measured using a motion-logger accelerometer device. Participants will wear the lotion logger watches on their non-dominant wrist at key points during the study (weeks 1, 4, 15). Data will be collected at 1min epochs.

Full Information

First Posted
August 16, 2016
Last Updated
August 28, 2019
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT02941718
Brief Title
Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Official Title
Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Smoking, Smoking cessation, Nicotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Advancement Counseling
Arm Type
Experimental
Arm Description
Participants will receive a 15-week intervention targeting smoking cessation and sleep counseling intervention. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. Sleep counseling components in the form of CBT for insomnia will be given as part of the smoking cessation counseling.
Arm Title
General Health Intervention
Arm Type
Active Comparator
Arm Description
Participants will receive a 15-week intervention targeting smoking cessation and general health information. Smoking Cessation intervention components include: 6 individual smoking cessation sessions over 15 weeks (week 1, 3, 4, 7, 11, 15) 12 weeks of the quit-smoking drug chantix. The standard dosing will be used - 0.5 mg once per day for days 1-3, 0.5my twice per day for days 4-7; and 1mg twice per day from week 3 until the end of treatment. The general health information counseling will be given as part of the smoking cessation counseling and topics include diet, physical activity, oral health, cancer screening and skin protection.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Advancement Counseling
Intervention Description
Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.
Intervention Type
Behavioral
Intervention Name(s)
General Health Information
Intervention Description
Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.
Primary Outcome Measure Information:
Title
Carbon Monoxide Level
Description
% of participants with a CO level of 10 or fewer parts per million (ppm)
Time Frame
15-week
Secondary Outcome Measure Information:
Title
Objective Sleep Duration and Timing
Description
Will be measured using a motion-logger accelerometer device. Participants will wear the lotion logger watches on their non-dominant wrist at key points during the study (weeks 1, 4, 15). Data will be collected at 1min epochs.
Time Frame
15-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults (>18 -65) who smoke at least 8 cigarettes/day; Report wanting to quit smoking in the next month No current diagnosis of psychosis or bipolar disorder. able to communicate in English and provide written informed consent for study procedures able to use varenicline safely. No current diagnosis of any sleep disorders (except of insomnia) Have access to a smart phone or tablet own the home Exclusion Criteria: 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, Current use of illicit drugs (e.g., cocaine, opioids, or methamphetamines), Current alcohol consumption that exceeds 14 standard alcoholic drinks/week for men, and more than 7 for women. Current use or recent discontinuation (within last 14 days) of anti-psychotic and/or bipolar disorder medications, Women who are pregnant, planning a pregnancy within the next 6 months, or lactating, Uncontrolled hypertension (SBP >160 or DBP >100) Current sleep disorder or use of sleep medication History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval), Any current suicidal ideation, or self-reported suicide attempt Current or past diagnosis of psychotic or bipolar disorder Currently working night/rotating shift. Allergy to Varenicline Unstable or untreated moderate or severe depression as assessed by the center for epidemiology studies depression scale 16 for higher.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freda Patterson, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27056396
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.
Results Reference
background
PubMed Identifier
26654569
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.
Results Reference
background
PubMed Identifier
19733449
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.
Results Reference
background
PubMed Identifier
18842256
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.
Results Reference
background
PubMed Identifier
18328642
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.
Results Reference
background

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Examination of Sleep, Smoking Cessation, and Cardiovascular Health

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