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Examination of Sleep, Smoking Cessation, and Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT02941718
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Freda Patterson, University of Delaware

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Sleep Advancement Counseling Behavioral: General Health Information Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sleep Advancement Counseling

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.

Behavioral: Sleep Advancement Counseling
Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.

Active Comparator: General Health Intervention

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.

Behavioral: General Health Information
Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.




Primary Outcome Measures :
  1. Carbon Monoxide Level [ Time Frame: 15-week ]
    % of participants with a CO level of 10 or fewer parts per million (ppm)


Secondary Outcome Measures :
  1. Objective Sleep Duration and Timing [ Time Frame: 15-weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941718


Contacts
Contact: Freda Patterson, PhD fredap@udel.edu

Locations
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19713
Contact: Freda Patterson, PhD    302-831-6588    fredap@udel.edu   
Principal Investigator: Freda Patterson, PhD         
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Freda Patterson, PhD University of Delaware

Publications:
Responsible Party: Freda Patterson, Assistant Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT02941718     History of Changes
Other Study ID Numbers: 887213
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Freda Patterson, University of Delaware:
Smoking
Smoking cessation
Nicotine

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders