Examination of Sleep, Smoking Cessation, and Cardiovascular Health
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/7/2018 |
| Start Date: | November 1, 2016 |
| End Date: | February 2019 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Newark, Delaware 19716
Principal Investigator: Freda Patterson, PhD
Phone: 302-831-6588
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