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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Advancement Counseling | Experimental | Participants will receive a 15-week intervention targeting smoking cessation and sleep counseling intervention. Smoking Cessation intervention components include:
Sleep counseling components in the form of CBT for insomnia will be given as part of the smoking cessation counseling. |
|
| General Health Intervention | Active Comparator | Participants will receive a 15-week intervention targeting smoking cessation and general health information. Smoking Cessation intervention components include:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Advancement Counseling | Behavioral | Participants will receive cognitive behavioral counseling on achieving adequate sleep duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide Level | % of participants with a CO level of 10 or fewer parts per million (ppm) | 15-week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freda Patterson, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27056396 | Background | 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. | |
| 26654569 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2018 | Aug 28, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| General Health Information | Behavioral | Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings. |
|
| 19733449 | Background | 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. |
| 18842256 | Background | 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. |
| 18328642 | Background | 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. |
| D015438 |
| Health Behavior |