Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

NCT02487953 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: Pro00063900P50DA027840
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking; Smoking cessation; Nicotine patches; E-cigarettes

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 4-8 post target Quit Day

Secondary Outcomes (3)

• Continuous four-week abstinence from smoking after withdrawal of ENDS

  Weeks 9-12 post target Quit Day

• Continuous four-week abstinence from smoking after withdrawal of nicotine patches

  Weeks 13-16 post target Quit Day

• Seven-day point abstinence from smoking at 6 months post Quit Day

  6 months post Quit Day

Study Arms (3)

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.

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.

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.

Drug: Nicotine patch; Other: Placebo ENDS

Interventions

Nicotine patch DRUG

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.

Also known as: Nicoderm

Nicotine ENDS + Nicotine Patch; Placebo ENDS + Nicotine Patch

ENDS OTHER

As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

Also known as: e-cigarettes

Nicotine ENDS + Nicotine Patch; Nicotine ENDS + Placebo Patch

Placebo patch OTHER

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.

Nicotine ENDS + Placebo Patch

Placebo ENDS OTHER

As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

Placebo ENDS + Nicotine Patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation; Vaping

Interventions

Tobacco Use Cessation Devices; Nicotine; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• James M Davis, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

US (1)