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Smoking CessationPhase 2NCT01443858

Meclizine as a Potential Smoking Cessation Treatment

A Phase 2 study testing Meclizine and Nicotine Patch in people with Smoking Cessation, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Smoking Cessation
What is being tested?
Meclizine and Nicotine Patch
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
4 sitesUnited States
Study dates
Aug 2011to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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;
  • 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.
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  • 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).

Who cannot join

  • 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;
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  • 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);
  • Brain abnormality (including but not limited to stroke, brain tumor, head injury and seizure disorder);
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • Problems giving blood samples;
  • 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);
  • Current depression;
  • Bulimia or anorexia;
  • Pregnant or nursing;
  • Smokes more than one cigar a month;
  • Regular alcohol use;
  • Significant adverse reaction to nicotine patches or meclizine 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.
  • Use (within the past 30 days) of:
  • Illegal drugs (or if the urine drug screen is positive),
  • 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), pipes or e-cigarettes;
  • Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.
  • Use (within the past 14 days) of:
  • Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed);
  • Benzodiazepines, antihistamines or other drugs with significant sedating or anticholinergic activity that may interact with meclizine.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Duke Center for Nicotine and Smoking Cessation Research

    Charlotte, North Carolina, 28210

  • Duke Center for Nicotine and Smoking Cessation Research

    Durham, North Carolina, 27705

  • Duke Center for Nicotine and Smoking Cessation Research

    Raleigh, North Carolina, 27609

  • Duke Center for Nicotine and Smoking Cessation Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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.

Being tested
Meclizine, Nicotine Patch, Placebo
Keywords
Smoking Cessation, Cigarette Smoking, Meclizine, Nicotine Patch
Medical subject headings
Smoking Cessation, Cigarette Smoking

What participants receive

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

  • MeclizineDrug

    Also called Antivert

    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.

  • Nicotine PatchDrug

    Also called Nicoderm

    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.

  • PlaceboDrug

    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.

Study groups in NCT01443858
Study groupRoleWhat they receive
Placebo + Nicotine PatchActive comparatorSubjects 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.
Receives: Drug: Nicotine Patch; Drug: Placebo
25mg Meclizine + Nicotine PatchExperimentalSubjects 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.
Receives: Drug: Meclizine; Drug: Nicotine Patch
50mg Meclizine + Nicotine PatchExperimentalSubjects 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.
Receives: Drug: Meclizine; Drug: Nicotine Patch

What is being measured

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

  1. 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.

    Measured: After 1 week of treatment (relative to baseline)

  2. 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.

    Measured: After 3 weeks of treatment (relative to baseline)

Secondary outcomes (3)

  1. Number of Participants Completing the Continuous 4 Week Abstinence From Smoking

    Continuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses

    Measured: weeks 3-6 post quit date

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

    To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.

    Measured: After 1 week of treatment (relative to baseline)

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

    To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.

    Measured: After 3 weeks of treatment (relative to baseline)

Timeline

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

  1. First posted30 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2012
  4. Study completionJul 2013

Resources

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, Investigator
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443858
Sponsor's protocol ID
Pro00030282
Status last verified
Jul 2014
First submitted
29 Sep 2011
Last updated
1 Aug 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Meclizine and Nicotine Patch in people with Smoking Cessation, run by Duke University at 4 sites 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 15 inclusion and 40 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1 (time frame: After 1 week of treatment (relative to baseline)). The study lists 2 primary outcomes in all. 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 NCT01443858.

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 1 Aug 2014.

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