NCT01926626

Brief Summary

The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 29, 2015

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 19, 2013

Results QC Date

June 8, 2015

Last Update Submit

August 17, 2017

Conditions

Nicotine Dependence

Keywords

Nicotine addictionSmoking CessationQuit SmokingmoclobemideNicotine Patch

Outcome Measures

Primary Outcomes (1)

  • Continuous Four-week Abstinence From Smoking

    Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).

    Weeks 6-10 post quit day

Secondary Outcomes (4)

  • Point Abstinence From Smoking at Six Months Post Quit

    7 day point abstinence from smoking at six months post quit

  • Continuous Ten Week Abstinence From Smoking

    10 weeks post quit day

  • Percentage of Change in Smoking Withdrawal Symptoms

    Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day

  • Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.

    Baseline and 1 week

Other Outcomes (2)

  • Safety of Moclobemide + Nicotine Patch

    1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch

  • Tolerability of Moclobemide + Nicotine Patch

    1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch

Study Arms (1)

Nicotine Patch+Moclobemide

EXPERIMENTAL

After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.

Drug: Nicotine PatchDrug: Moclobemide

Interventions

Nicotine PatchDRUG

Pre-Quit Period: 2 weeks of patch use (21mg/24hr) Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)

Also known as: Nicoderm
Nicotine Patch+Moclobemide
MoclobemideDRUG

Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses) Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)

Also known as: reversible MAO-A inhibitor
Nicotine Patch+Moclobemide

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have no known serious medical conditions;
  • Female;
  • Are 18-65 years old;
  • Smoke an average of at least 20 cigarettes per day;
  • Have smoked at least one cumulative year;
  • Have a Fagerstrom Test for Nicotine Dependence score of at least 5;
  • Have an expired air carbon monoxide (CO) reading of at least 10ppm;
  • Able to read and understand English;
  • Express a desire to quit smoking in the next thirty days.
  • Potential subjects must agree to avoid the following during their participation in this study:
  • excessive alcohol consumption;
  • use of other antidepressants;
  • general anesthesia;
  • 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;
  • +5 more criteria

You may not qualify if:

  • Hypertension;
  • Hypotension with symptoms;
  • Coronary heart disease;
  • Lifetime history of heart attack;
  • Cardiac rhythm disorder;
  • Chest pains;
  • Cardiac (heart) disorder;
  • Active skin disorder;
  • Liver or kidney disorder;
  • Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
  • Active ulcers in the past 30 days;
  • Currently Symptomatic lung disorder/disease;
  • Brain abnormality;
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke Center for Smoking Cessation

Charlotte, North Carolina, 28210, United States

Location

Duke Center forSmoking Cessation

Durham, North Carolina, 27705, United States

Location

Duke Center for Smoking Cessation

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Tobacco Use Cessation DevicesNicotineMoclobemide

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

August 23, 2017

Results First Posted

July 29, 2015

Record last verified: 2017-08

Locations

US(3)