NCT02941718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

August 16, 2016

Last Update Submit

August 28, 2019

Conditions

Nicotine Dependence

Keywords

SmokingSmoking cessationNicotine

Outcome Measures

Primary Outcomes (1)

  • Carbon Monoxide Level

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

    15-week

Secondary Outcomes (1)

  • Objective Sleep Duration and Timing

    15-weeks

Study Arms (2)

Sleep Advancement Counseling

EXPERIMENTAL

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

General Health Intervention

ACTIVE COMPARATOR

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

Interventions

Sleep Advancement CounselingBEHAVIORAL

Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.

Sleep Advancement Counseling
General Health InformationBEHAVIORAL

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

General Health Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (5)

  • 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.

    PMID: 27056396BACKGROUND

  • 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.

    PMID: 26654569BACKGROUND

  • 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.

    PMID: 19733449BACKGROUND

  • 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.

    PMID: 18842256BACKGROUND

  • 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.

    PMID: 18328642BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

  • Freda Patterson, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2016

First Posted

October 21, 2016

Study Start

November 1, 2016

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)