Nicotine DependencePhase 3NCT02941718
Examination of Sleep, Smoking Cessation, and Cardiovascular Health
A Phase 3 study testing Sleep Advancement Counseling and General Health Information in people with Nicotine Dependence, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Sleep Advancement Counseling and General Health Information
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 17 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Sleep Advancement Counseling, General Health Information
- Keywords
- Smoking, Smoking cessation, Nicotine
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Advancement CounselingBehavioural
Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.
General Health InformationBehavioural
Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General Health Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Monoxide Level
% of participants with a CO level of 10 or fewer parts per million (ppm)
Measured: 15-week
Secondary outcomes (1)
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.
Measured: 15-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freda Patterson, University of Delaware
- Investigators
- Freda Patterson, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941718
- Sponsor's protocol ID
- 887213
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27056396Malone 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.
PubMed 26654569Patterson 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.
PubMed 19733449Patterson 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.
PubMed 18842256Patterson 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.
PubMed 18328642
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Sleep, Smoking Cessation, and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02941718
- Acronym / sponsor ID
- 887213
- Conditions
- Nicotine Dependence
- Keywords
- Smoking, Smoking cessation, Nicotine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Advancement Counseling | Experimental | Behavioral: Sleep Advancement CounselingParticipants 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. |
| General Health Intervention | Active comparator | Behavioral: General Health InformationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Advancement CounselingParticipants will receive cognitive behavioral counseling on achieving adequate sleep duration. | Behavioural | Sleep Advancement Counseling |
| General Health InformationParticipants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings. | Behavioural | General Health Intervention |
Primary outcome
Carbon Monoxide Level
Time frame: 15-week
% of participants with a CO level of 10 or fewer parts per million (ppm)
1 secondary outcome
Objective Sleep Duration and Timing
Time frame: 15-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 27056396Patterson 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.
- Background: PubMed 26654569Malone 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.
- Background: PubMed 19733449Patterson 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.
- Background: PubMed 18842256Patterson 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.
- Background: PubMed 18328642Patterson 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.
- Individual participant dataSharing planned: No
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freda Patterson, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sleep Advancement Counseling and General Health Information in people with Nicotine Dependence, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon Monoxide Level (time frame: 15-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941718, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.