Examination of Sleep, Smoking Cessation, and Cardiovascular Health

August 28, 2019 updated by: Freda Patterson, University of Delaware
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbon Monoxide Level
Time Frame: 15-week
% of participants with a CO level of 10 or fewer parts per million (ppm)
15-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Investigators

  • Principal Investigator: Freda Patterson, PhD, University of Delaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 17, 2019

Study Completion (Actual)

January 17, 2019

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 887213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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