Clinical trial NCT01926626: Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Official title: Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: Nicotine addiction
Smoking Cessation
Quit Smoking
moclobemide
Nicotine Patch
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Philip Morris USA, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2013-08-21
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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;
* use of experimental (investigational) drugs or devices;
* use of illegal drugs;
* cimetidine;
* Tyramine rich foods;
* use of opiate medications.

Exclusion Criteria:

* 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;
* Problems giving blood samples;
* Diabetes (unless controlled by diet and exercise alone);
* Current cancer or treatment for cancer in the past six;
* Other major medical condition;
* Current psychiatric disease;
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Use (within the past 45 days) of psychiatric medications including antidepressants and anti-psychotics;
* 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;
  * Any medications that are known to affect smoking cessation (e.g. clonidine);
  * Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
  * Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
* Smokes more than one cigar a month.
* Alcohol abuse;
* Significant adverse reaction to nicotine patches, in the past.
* Known hypersensitivity to moclobemide or other MAO-A inhibitors.
* Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
* Current participation or recent participation (in the past six months) in another medical research study.

Primary outcomes:
measure: Continuous Four-week Abstinence From Smoking
timeFrame: Weeks 6-10 post quit day
Secondary outcomes:
measure: Point Abstinence From Smoking at Six Months Post Quit
timeFrame: 7 day point abstinence from smoking at six months post quit
measure: Continuous Ten Week Abstinence From Smoking
timeFrame: 10 weeks post quit day
measure: Percentage of Change in Smoking Withdrawal Symptoms
timeFrame: Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day
measure: Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.
timeFrame: Baseline and 1 week
Other outcomes:
measure: Safety of Moclobemide + Nicotine Patch
timeFrame: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
measure: Tolerability of Moclobemide + Nicotine Patch
timeFrame: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
Locations:
city: Charlotte
country: United States
facility: Duke Center for Smoking Cessation
state: North Carolina
city: Durham
country: United States
facility: Duke Center forSmoking Cessation
state: North Carolina
city: Winston-Salem
country: United States
facility: Duke Center for Smoking Cessation
state: North Carolina
Study officials:
affiliation: Duke University
name: Jed E Rose, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: