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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA038253-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.
The proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the COMT inhibitor, tolcapone, in nicotine dependent women. This study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. Withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. Smoking urges will be assessed by a self-report scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolcapone | Active Comparator | 100mg tolcapone three times a day for 7 days then 100mg once a day on day 8 |
|
| Sugar Pill | Placebo Comparator | Sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolcapone | Drug | Tolcapone will be compared to sugar pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Symptoms (MNWS Score) | The MNWS was the 8 item version, using VAS scales for each item (1-100), and MNWS score calculated as an average of all items (range of possible scores for MWNS at each timepoint was 0-100, with higher MNWS scores at each timepoint indicating more withdrawal symptoms (worse outcome). Timepoints reflect 1.) the baseline (beginning of the trial, not yet receiving any pills, not yet being asked to abstain from smoking; calculated as average of scores from two visits: ad libitum baseline visit and pill day 1 measure which was collected prior to administration of pills) and 2.) the abstinence period (tolcapone or placebo pill days 6-8, during the 60-hr abstinence phase; calculated as average of scores from 3 visits: pill days 6, 7, and 8). Greater increases in scores (increases in withdrawal symptoms) during abstinence period compared to baseline reflects a worse outcome; reduced or stable scores (decreases or a lack of increases in withdrawal symptoms) during the abstinence period compa | Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8) |
| Smoking Urges (BQSU Factor 1) | The Brief Questionnaire on Smoking Urges (BQSU) is a 10 item scale. Factor 1 reflects the urge to smoke for its rewarding properties. Factor 1 is calculated as the sum of five items (items 1, 3, 6, 7, 10), with each item score ranging from 1-7, so Factor 1 scores range from 5-35. Higher scores reflect higher smoking urges and represent a worse outcome. Timepoints reflect 1.) baseline (beginning of trial, not yet receiving pills, not yet abstaining from smoking; calculated as average of scores from ad libitum baseline visit and pill day 1 which was collected prior to administration of pills) and 2.) abstinence period (pill days 6-8, during 60-hr abstinence phase; calculated as average of scores from pill days 6, 7, and 8). Greater increases in scores (increases in smoking urges) during abstinence period compared to baseline reflects a worse outcome; decreases or a lack of increases in smoking urges during the abstinence period compared to baseline reflects a better outcome. | Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8) |
| Smoking Choice Paradigm: Amount Earned ($) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elise DeVito, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Administration Hospital | West Haven | Connecticut | 06516 | United States |
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36 consented to be in the study, completed a baseline session, and were randomized to a study arm. However, 4 subjects never actually began the medication trial (i.e., stopped participating prior to receiving any pills (tolcapone or placebo)). 32 subjects began the pill portion of the trial (i.e., started tolcapone or placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolcapone | 100mg tolcapone three times a day for 7 days then 100mg once a day on day 8 |
| FG001 | Sugar Pill | Sugar pill (placebo) three times a day for 7 days then once on day 8 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible and completed baseline assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolcapone | 100mg tolcapone three times a day for 7 days then 100mg once a day on day 8 |
| BG001 | Sugar Pill | Sugar pill (placebo) three times a day for 7 days then once on day 8 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Withdrawal Symptoms (MNWS Score) | The MNWS was the 8 item version, using VAS scales for each item (1-100), and MNWS score calculated as an average of all items (range of possible scores for MWNS at each timepoint was 0-100, with higher MNWS scores at each timepoint indicating more withdrawal symptoms (worse outcome). Timepoints reflect 1.) the baseline (beginning of the trial, not yet receiving any pills, not yet being asked to abstain from smoking; calculated as average of scores from two visits: ad libitum baseline visit and pill day 1 measure which was collected prior to administration of pills) and 2.) the abstinence period (tolcapone or placebo pill days 6-8, during the 60-hr abstinence phase; calculated as average of scores from 3 visits: pill days 6, 7, and 8). Greater increases in scores (increases in withdrawal symptoms) during abstinence period compared to baseline reflects a worse outcome; reduced or stable scores (decreases or a lack of increases in withdrawal symptoms) during the abstinence period compa | Study completers (participants who were eligible, randomized to a treatment condition, and completed the study). | Posted | Mean | Standard Deviation | score on a scale | Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8) |
During the medication phase (8 days) and follow-up (1 week).
Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 32 of 36 patients, 17 in Tolcapone arm and 15 in Sugar Pill arm.
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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 | Tolcapone | 100mg tolcapone three times a day for 7 days then 100mg once a day on day 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach pain | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elise E. DeVito, Ph.D./ Associate Research Scientist | Yale University | 203-737-4882 | elise.devito@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2019 | Aug 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2014 | Aug 18, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077867 | Tolcapone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Sugar Pill | Drug | The sugar pill (placebo) will be compared to tolcapone |
|
|
The Smoking Choice Paradigm was done once at the end of the trial (Pill Day 8, at the end of the 60 hr abstinence period). Subjects are given forced choice options between 2 puffs of their own-brand cigarette vs. a token with a monetary value, spaced over a 90 minute period. The maximum amount subjects can earn from this task ranges from $0 to $7.50 (10 forced choice opportunities: smoke 2 puffs vs. earn 75 cent at each choice opportunity). Higher earnings reflect choice of the tokens over smoking, so this reflects a better outcome (i.e., reduced smoking choice).
| Pill-Day 8 (end of trial) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Tolcapone | 100mg tolcapone three times a day for 7 days then 100mg once a day on day 8 |
| OG001 | Sugar Pill | Sugar pill (placebo) three times a day for 7 days then once on day 8 |
|
|
|
| Primary | Smoking Urges (BQSU Factor 1) | The Brief Questionnaire on Smoking Urges (BQSU) is a 10 item scale. Factor 1 reflects the urge to smoke for its rewarding properties. Factor 1 is calculated as the sum of five items (items 1, 3, 6, 7, 10), with each item score ranging from 1-7, so Factor 1 scores range from 5-35. Higher scores reflect higher smoking urges and represent a worse outcome. Timepoints reflect 1.) baseline (beginning of trial, not yet receiving pills, not yet abstaining from smoking; calculated as average of scores from ad libitum baseline visit and pill day 1 which was collected prior to administration of pills) and 2.) abstinence period (pill days 6-8, during 60-hr abstinence phase; calculated as average of scores from pill days 6, 7, and 8). Greater increases in scores (increases in smoking urges) during abstinence period compared to baseline reflects a worse outcome; decreases or a lack of increases in smoking urges during the abstinence period compared to baseline reflects a better outcome. | Study completers (participants who were eligible, randomized to a treatment condition, and completed the study). | Posted | Mean | Standard Deviation | score on a scale | Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8) |
|
|
|
|
| Primary | Smoking Choice Paradigm: Amount Earned ($) | The Smoking Choice Paradigm was done once at the end of the trial (Pill Day 8, at the end of the 60 hr abstinence period). Subjects are given forced choice options between 2 puffs of their own-brand cigarette vs. a token with a monetary value, spaced over a 90 minute period. The maximum amount subjects can earn from this task ranges from $0 to $7.50 (10 forced choice opportunities: smoke 2 puffs vs. earn 75 cent at each choice opportunity). Higher earnings reflect choice of the tokens over smoking, so this reflects a better outcome (i.e., reduced smoking choice). | Study completers (participants who were eligible, randomized to a treatment condition, and completed the study). | Posted | Mean | Standard Deviation | Dollars ($) | Pill-Day 8 (end of trial) |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 12 |
| 17 |
| EG001 | Sugar Pill | Sugar pill (placebo) three times a day for 7 days then once on day 8 | 0 | 15 | 0 | 15 | 14 | 15 |
| Upset stomach | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Loss of appetite | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Difficulty sleeping | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Feeling drowsy | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Extreme tiredness (fatigue) | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Anger or irritability | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Teary or dry eyes | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Nosebleed | General disorders | SAFTEE | Non-systematic Assessment |
|
| Runny nose | General disorders | SAFTEE | Non-systematic Assessment |
|
| Back muscle or bone pain | Musculoskeletal and connective tissue disorders | SAFTEE | Non-systematic Assessment |
|
| Sweating | General disorders | SAFTEE | Non-systematic Assessment |
|
| Rash or skin problem | Skin and subcutaneous tissue disorders | SAFTEE | Non-systematic Assessment |
|
| Excessive Hunger | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Inability to respond to things around you | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Change in ability to taste food | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Headache | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Tremors or shakiness | General disorders | SAFTEE | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Slowed thinking | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Tingling in fingers or toes | General disorders | SAFTEE | Non-systematic Assessment |
|
| Sore Throat | General disorders | SAFTEE | Non-systematic Assessment |
|
| Fever | General disorders | SAFTEE | Non-systematic Assessment |
|
| Chills | General disorders | SAFTEE | Non-systematic Assessment |
|
| Slow heart rate | Cardiac disorders | SAFTEE | Non-systematic Assessment |
|
| Crossed eyes | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Gas | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Irregular or pounding heartbeat | Cardiac disorders | SAFTEE | Non-systematic Assessment |
|
| Feeling dizzy or faint or lighheaded | General disorders | SAFTEE | Non-systematic Assessment |
|
| Weightloss | Metabolism and nutrition disorders | SAFTEE | Non-systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | SAFTEE | Non-systematic Assessment |
|
| Eye pain | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Numbness or tingling around mouth | General disorders | SAFTEE | Non-systematic Assessment |
|
| Problems with urination | Renal and urinary disorders | SAFTEE | Non-systematic Assessment |
|
| Slowed movements | General disorders | SAFTEE | Non-systematic Assessment |
|
| Sudden hunger | General disorders | SAFTEE | Non-systematic Assessment |
|
| Trouble speaking or swallowing | General disorders | SAFTEE | Non-systematic Assessment |
|
| Difficulty concentrating | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Memory problems | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Seizures | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Swelling of tongue | General disorders | SAFTEE | Non-systematic Assessment |
|
| Trouble with gums | General disorders | SAFTEE | Non-systematic Assessment |
|
| Extreme thirst | General disorders | SAFTEE | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | SAFTEE | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | SAFTEE | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Aggressive behavior | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | SAFTEE | Non-systematic Assessment |
|
| Dandruff | Skin and subcutaneous tissue disorders | SAFTEE | Non-systematic Assessment |
|
| Growth of hair in unusual places | Endocrine disorders | SAFTEE | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | SAFTEE | Non-systematic Assessment |
|
| Trouble walking | Musculoskeletal and connective tissue disorders | SAFTEE | Non-systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | SAFTEE | Non-systematic Assessment |
|
| Involuntary eye movements | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Near Sightedness | Eye disorders | SAFTEE | Non-systematic Assessment |
|
| Breast pain (female only) | Reproductive system and breast disorders | SAFTEE | Non-systematic Assessment |
|
| Painful menstrual periods (female only) | Reproductive system and breast disorders | SAFTEE | Non-systematic Assessment |
|
| Missed menstrual periods (female only) | Reproductive system and breast disorders | SAFTEE | Non-systematic Assessment |
|
| Excessive Menstrual Bleeding (female only) | Reproductive system and breast disorders | SAFTEE | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009596 | Nitrophenols |
| D010636 | Phenols |
| D007659 | Ketones |
| D009574 | Nitro Compounds |
| D002241 | Carbohydrates |