- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926626
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers (RIMA)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Duke Center for Smoking Cessation
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Durham, North Carolina, United States, 27705
- Duke Center forSmoking Cessation
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Winston-Salem, North Carolina, United States, 27103
- Duke Center for Smoking Cessation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nicotine Patch+Moclobemide
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.
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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)
Other Names:
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)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous Four-week Abstinence From Smoking
Time Frame: Weeks 6-10 post quit day
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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).
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Weeks 6-10 post quit day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Abstinence From Smoking at Six Months Post Quit
Time Frame: 7 day point abstinence from smoking at six months post quit
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Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.
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7 day point abstinence from smoking at six months post quit
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Continuous Ten Week Abstinence From Smoking
Time Frame: 10 weeks post quit day
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Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.
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10 weeks post quit day
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Percentage of Change in Smoking Withdrawal Symptoms
Time Frame: Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day
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Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely.
The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal.
The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
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Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day
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Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.
Time Frame: Baseline and 1 week
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The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).
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Baseline and 1 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Moclobemide + Nicotine Patch
Time Frame: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
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Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate".
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1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
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Tolerability of Moclobemide + Nicotine Patch
Time Frame: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
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Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).
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1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Antidepressive Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Monoamine Oxidase Inhibitors
- Nicotine
- Moclobemide
Other Study ID Numbers
- Pro00044174
- P50DA027840-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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