Meclizine as a Potential Smoking Cessation Treatment

NCT01443858 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00030282
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent or treat motion sickness, can help smokers quit smoking. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Cigarette Smoking; Meclizine; Nicotine Patch

Outcome Measures

Primary Outcomes (2)

• Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1

  To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.

  After 1 week of treatment (relative to baseline)

• Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3

  To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.

  After 3 weeks of treatment (relative to baseline)

Secondary Outcomes (3)

• Number of Participants Completing the Continuous 4 Week Abstinence From Smoking

  weeks 3-6 post quit date

• Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers

  After 1 week of treatment (relative to baseline)

• Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers

  After 3 weeks of treatment (relative to baseline)

Study Arms (3)

Placebo + Nicotine Patch

ACTIVE COMPARATOR

Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.

Drug: Nicotine Patch; Drug: Placebo

25mg Meclizine + Nicotine Patch

EXPERIMENTAL

Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.

Drug: Meclizine; Drug: Nicotine Patch

50mg Meclizine + Nicotine Patch

EXPERIMENTAL

Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.

Drug: Meclizine; Drug: Nicotine Patch

Interventions

Meclizine DRUG

Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.

Also known as: Antivert

25mg Meclizine + Nicotine Patch; 50mg Meclizine + Nicotine Patch

Nicotine Patch DRUG

Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily. Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.

Also known as: Nicoderm

25mg Meclizine + Nicotine Patch; 50mg Meclizine + Nicotine Patch; Placebo + Nicotine Patch

Placebo DRUG

Pre-Quit Period: In this group, participants will take placebo capsules daily during the three week pre-quit period. The placebo will be taken in two doses daily, one capsule with breakfast and one with dinner.

Placebo + 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;
• Are 18-65 years old;
• Smoke an average of at least 10 cigarettes per day;
• Have smoked at least one cumulative year;
• Have an afternoon expired air carbon monoxide (CO) reading of at least 10ppm;
• Express a desire to quit smoking in the next thirty days.
• Potential subjects must agree to use acceptable contraception during their participation in this study.
• Potential subjects must agree to avoid the following during their participation in this study:
• 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
• use of anti-histamines;
• use of alcohol (during first three weeks of study participation).

You may not qualify if:

• Inability to attend all required experimental sessions;
• Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
• Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg).
• Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
• 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, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
• Liver or kidney disorder (except kidney stones, gallstones);
• Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
• Active ulcers in the past 30 days;
• Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);

Sponsors & Collaborators

• Duke University: lead
• Philip Morris USA, Inc.: collaborator

Study Sites (4)

Duke Center for Nicotine and Smoking Cessation Research

Charlotte, North Carolina, 28210, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Durham, North Carolina, 27705, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Raleigh, North Carolina, 27609, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking

Interventions

Meclizine; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Solanaceous Alkaloids; Alkaloids; Pyridines

Results Point of Contact

• Title: Dr. Jed E. Rose
• Organization: Duke Center for Smoking Cessation

jed.rose@duke.edu

919-668-5055

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: May 8, 2014

Record last verified: 2014-07

Locations

US (4)