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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA027840-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Philip Morris USA, Inc. | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Point Abstinence From Smoking at Six Months Post Quit | Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO. | 7 day point abstinence from smoking at six months post quit |
| Continuous Ten Week Abstinence From Smoking |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Moclobemide + Nicotine Patch | Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate". | 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch |
| Tolerability of Moclobemide + Nicotine Patch |
Inclusion Criteria:
Potential subjects must agree to avoid the following during their participation in this study:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jed E Rose, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Smoking Cessation | Charlotte | North Carolina | 28210 | United States | ||
| Duke Center forSmoking Cessation |
Of the 76 participants who were enrolled, 38 participants attended Study Session 1: 1 participant voluntarily withdrew prior to Study Session 1, 3 participants were lost to contact prior to Study Session 1, and 34 were withdrawn from the study by the PI or medical staff because they did not meet inclusion criteria or met exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Nicotine Patch: 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) Moclobemide: 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Nicotine Patch: 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) Moclobemide: 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | Weeks 6-10 post quit day |
|
Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Nicotine Patch: 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) Moclobemide: 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jed E. Rose | Duke Center for Smoking Cessation | 919-668-5055 | jed.rose@duke.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D020912 | Moclobemide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Moclobemide | Drug | 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) |
|
|
Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO. |
| 10 weeks post quit day |
| Percentage of Change in Smoking Withdrawal Symptoms | 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. | 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. | 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). | Baseline and 1 week |
Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication). |
| 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Duke Center for Smoking Cessation | Winston-Salem | North Carolina | 27103 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Point Abstinence From Smoking at Six Months Post Quit | Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO. | Posted | Number | participants | 7 day point abstinence from smoking at six months post quit |
|
|
|
| Secondary | Continuous Ten Week Abstinence From Smoking | Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO. | Posted | Number | participants | 10 weeks post quit day |
|
|
|
| Secondary | Percentage of Change in Smoking Withdrawal Symptoms | 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. | Posted | Mean | Standard Error | percentage of change | Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day |
|
|
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| Other Pre-specified | Safety of Moclobemide + Nicotine Patch | Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate". | Participants who received Moclobemide. | Posted | Number | participants | 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch |
|
|
|
| Secondary | Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment. | 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). | Participants who received Moclobemide. | Posted | Mean | Standard Error | percentage of change | Baseline and 1 week |
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| Other Pre-specified | Tolerability of Moclobemide + Nicotine Patch | Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication). | Participants who received Moclobemide. | Posted | Number | participants | 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch |
|
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| 0 |
| 37 |
| 29 |
| 37 |
| Tiredness | Nervous system disorders | Systematic Assessment |
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| Nightmares | Nervous system disorders | Systematic Assessment |
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| Vivid dreams | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Excessive sweating | Nervous system disorders | Systematic Assessment |
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| Increased appetite | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Altered taste | Nervous system disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Thirst | General disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Muscle / joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Agitation / restlessness | Nervous system disorders | Systematic Assessment |
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| Itching at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D001519 | Behavior |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Craving -- % change 10 weeks from Quit Day |
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| Craving -- % change 6 months from Quit Day |
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| Negative Affect -- % change 1 week from Quit Day |
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| Negative Affect -- % change 3 weeks from Quit Day |
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| Negative Affect -- % change 6 weeks from Quit Day |
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| Negative Affect -- % change 10 weeks from Quit Day |
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| Negative Affect -- % change 6 months from Quit Day |
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| Appetite -- % change 1 week from Quit Day |
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| Appetite -- % change 3 weeks from Quit Day |
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| Appetite -- % change 6 weeks from Quit Day |
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| Appetite -- % change 10 weeks from Quit Day |
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| Appetite -- % change 6 months from Quit Day |
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| Arousal -- % change 1 week from Quit Day |
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| Arousal -- % change 3 weeks from Quit Day |
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| Arousal -- % change 6 weeks from Quit Day |
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| Arousal -- % change 10 weeks from Quit Day |
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| Arousal -- % change 6 months from Quit Day |
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| Anxiety -- % change 1 week from Quit Day |
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| Anxiety -- % change 3 weeks from Quit Day |
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| Anxiety -- % change 6 weeks from Quit Day |
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| Anxiety -- % change 10 weeks from Quit Day |
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| Anxiety -- % change 6 months from Quit Day |
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| Gastrointestinal -- % change 1 week from Quit Day |
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| Gastrointestinal -- % change 3 weeks from Quit Day |
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| Gastrointestinal -- % change 6 weeks from Quit Day |
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| Gastrointestinal - % change 10 weeks from Quit Day |
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| Gastrointestinal - % change 6 months from Quit Day |
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| Respiratory -- % change 1 week from Quit Day |
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| Respiratory -- % change 3 weeks from Quit Day |
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| Respiratory -- % change 6 weeks from Quit Day |
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| Respiratory -- % change 10 weeks from Quit Day |
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| Respiratory -- % change 6 months from Quit Day |
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| Habit -- % change 1 week from Quit Day |
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| Habit -- % change 3 weeks from Quit Day |
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| Habit -- % change 6 weeks from Quit Day |
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| Habit -- % change 10 weeks from Quit Day |
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| Habit -- % change 6 months from Quit Day |
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