Nicotine DependencePhase 2ENDS-P50NCT02487953

Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

A Phase 2 study testing Nicotine patch and ENDS in people with Nicotine Dependence, run by Duke University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Nicotine Dependence
What is being tested?: Nicotine patch and ENDS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Jul 2018to Jan 2022
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Have no known serious medical conditions;
Smoke an average of at least 10 cigarettes per day;
Have an expired air CO reading of at least 15 ppm;
Able to read and understand English;
Express a desire to quit smoking in the next thirty days;
Higher than median rating of enjoyment of airway sensory effects of inhaling smoke on Cigarette Evaluation Questionnaire.

Who cannot join

Hypertension;
Hypotension;
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder (irregular heart rhythm);
Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);

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Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
History of skin allergy;
Active skin disorder (e.g., psoriasis) within the last five years;
Liver or kidney disorder (except kidney stones, gallstones);
Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
Ulcers;
Lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
History of migraine headaches in the past 5 years;
History of fainting;
Problems giving blood samples;
Difficulty passing urine;
Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
Other major medical condition;
Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
Current depression;
Bulimia or anorexia;
Pregnant or nursing mothers;
Use (within the past 30 days) of:
Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
Experimental (investigational) drugs;
Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
Smokeless tobacco (chewing tobacco, snuff), cigars, pipes, nicotine replacement therapy, e-cigarettes or other smoking cessation treatment;;
Alcohol abuse;
Significant adverse reaction to nicotine patches in the past;
Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility;
Current participation in another research study.
Potential subjects must agree to use acceptable contraception.
Potential subjects must agree to avoid the following:
participation in any other nicotine-related modification strategy outside of this protocol;
use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
use of experimental (investigational) drugs or devices;
use of illegal drugs;
use of opiate medications.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Center for Smoking Cessation
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Electronic Nicotine Delivery Systems (ENDS) as a Smoking Cessation Treatment

Read the detailed description

Cigarette smokers, who are motivated to quit smoking but who rate the inhalation aspects of smoking as important will be randomized to three groups: Group 1. Nicotine ENDS + nicotine patch; Group 2: Nicotine ENDS + placebo patch; Group 3: Placebo ENDS + Nicotine patch. Participants will initially receive 1 week of 21 mg nicotine (or placebo) skin patches while continuing to smoke their usual cigarettes ad lib, in order to assess responsiveness to Nicotine Replacement Therapy (NRT). Starting with week 2, participants will receive nicotine-containing (or placebo) ENDS devices (menthol or non-menthol versions in accordance with their baseline preference). They will also be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Conditions: Nicotine Dependence
Being tested: Nicotine patch, ENDS, Placebo patch, Placebo ENDS
Keywords: Nicotine addiction, Cigarette smoking, Smoking cessation, Nicotine patches, E-cigarettes
Medical subject headings: Tobacco Use Disorder, Cigarette Smoking, Smoking Cessation, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicotine patchDrug
Also called Nicoderm
21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
ENDSOther
Also called e-cigarettes
As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
Placebo patchOther
21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.
Placebo ENDSOther
As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

Study groups in NCT02487953
Study group	Role	What they receive
Nicotine ENDS + Nicotine Patch	Experimental	Participants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date. Receives: Drug: Nicotine patch; Other: ENDS
Nicotine ENDS + Placebo Patch	Active comparator	Participants will initially receive 1 week of placebo skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the placebo patch size will be gradually reduced to mirror standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date. Receives: Other: ENDS; Other: Placebo patch
Placebo ENDS + Nicotine Patch	Active comparator	Participants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive placebo ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date. Receives: Drug: Nicotine patch; Other: Placebo ENDS

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous four-week abstinence from smoking during treatment
The primary outcome measure will be continuous four-week abstinence from smoking during weeks 4-8 post target Quit Day while treatment is ongoing. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) <10 ppm (measured at Week 8). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Measured: Weeks 4-8 post target Quit Day

Secondary outcomes (3)

Continuous four-week abstinence from smoking after withdrawal of ENDS
A secondary outcome measure will be continuous four-week abstinence from smoking during weeks 9-12 post target Quit Day while participants are decreasing their use of ENDS. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) <10 ppm (measured at Week 12). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Measured: Weeks 9-12 post target Quit Day
Continuous four-week abstinence from smoking after withdrawal of nicotine patches
A secondary outcome measure will be continuous four-week abstinence from smoking during weeks 13-16 post target Quit Day while participants are using decreasing doses of nicotine patches. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) <10 ppm (measured at Week 16). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Measured: Weeks 13-16 post target Quit Day
Seven-day point abstinence from smoking at 6 months post Quit Day
A secondary outcome measure will be seven-day abstinence from smoking at six months post target Quit Day. This will be determined by self-report of no smoking for the previous seven days when called for 6-month follow-up, verified by expired air carbon monoxide (CO) <10 ppm (measured at 6-month follow-up visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Measured: 6 months post Quit Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2018Jan 2022

First posted2 Jul 2015 (estimated)
Study startJul 2018 (estimated)
Primary completionJan 2020 (estimated)
Study completionJan 2022 (estimated)

Why it stopped: Study design changed significantly; was submitted as a different protocol.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nicotine DependenceStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02487953
Sponsor's protocol ID: Pro00063900
Other IDs: P50DA027840
Acronym: ENDS-P50
Status last verified: Sep 2018
First submitted: 30 Jun 2015
Last updated: 12 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electronic Nicotine Delivery Systems (ENDS) as a Smoking Cessation Treatment
ClinicalTrials.gov ID: NCT02487953
Acronym / sponsor ID: ENDS-P50 / Pro00063900
Conditions: Nicotine Dependence
Keywords: Nicotine addiction, Cigarette smoking, Smoking cessation, Nicotine patches, E-cigarettes
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study design changed significantly; was submitted as a different protocol.
Enrolment: 0 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jul 2018 (estimated)
Primary completion: Jan 2020 (estimated)
Study completion: Jan 2022 (estimated)
First posted: 2 Jul 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Nicotine ENDS + Nicotine Patch	Experimental	Drug: Nicotine patch, Other: ENDSParticipants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.
Nicotine ENDS + Placebo Patch	Active comparator	Other: ENDS, Other: Placebo patchParticipants will initially receive 1 week of placebo skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the placebo patch size will be gradually reduced to mirror standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.
Placebo ENDS + Nicotine Patch	Active comparator	Drug: Nicotine patch, Other: Placebo ENDSParticipants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive placebo ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Have no known serious medical conditions;
Smoke an average of at least 10 cigarettes per day;
Have an expired air CO reading of at least 15 ppm;
Able to read and understand English;
Express a desire to quit smoking in the next thirty days;

Key exclusion criteria (42 listed)

Hypertension;
Hypotension;
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder (irregular heart rhythm);

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
Nicotine patchAlso: Nicoderm21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.	Drug	Nicotine ENDS + Nicotine Patch, Placebo ENDS + Nicotine Patch
ENDSAlso: e-cigarettesAs needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.	Other	Nicotine ENDS + Nicotine Patch, Nicotine ENDS + Placebo Patch
Placebo patch21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.	Other	Nicotine ENDS + Placebo Patch
Placebo ENDSAs needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.	Other	Placebo ENDS + Nicotine Patch

Primary outcome

Continuous four-week abstinence from smoking during treatment
Time frame: Weeks 4-8 post target Quit Day
The primary outcome measure will be continuous four-week abstinence from smoking during weeks 4-8 post target Quit Day while treatment is ongoing. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) <10 ppm (measured at Week 8). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.

3 secondary outcomes

Continuous four-week abstinence from smoking after withdrawal of ENDS
Time frame: Weeks 9-12 post target Quit Day
Continuous four-week abstinence from smoking after withdrawal of nicotine patches
Time frame: Weeks 13-16 post target Quit Day
Seven-day point abstinence from smoking at 6 months post Quit Day
Time frame: 6 months post Quit Day

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.

Related trials for Nicotine Dependence

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Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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Social Media Support Groups for Adolescent Vaping Cessation
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Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
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RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
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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.

Jed E Rose, Ph.D. principal investigator

Duke University

James M Davis, M.D. principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nicotine patch and ENDS in people with Nicotine Dependence, run by Duke University 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 6 inclusion and 42 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: withdrawn, as of the sponsor's last update on 12 Sep 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Continuous four-week abstinence from smoking during treatment (time frame: Weeks 4-8 post target Quit Day). 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 NCT02487953.

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 12 Sep 2018.