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| Name | Class |
|---|---|
| University of Miami | OTHER |
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The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Combination Therapy | Experimental | Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjust as need it |
|
| Standard Care Intervention | Active Comparator | Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Therapy | Other | Brief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 3 months |
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 6 months |
| Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jose Miguez, MD | Florida International University | Principal Investigator |
| Guillermo Castro, MD | University of Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
The data will be available only after the study have 2 years of completion. The data to be shared will be de-identified and without data associated with medical records. Access will be provided upon submission of study protocol and if the IRB approves sharing the data.
The data will be available only after two years of study completion
Requires full disclosure of aims and hypothesis Approval by the center and the IRB committees Signing a limited use agreement
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488 participants signed consent forms, a total 11 were excluded (6 did not meet smoking criteria, 3 were not compliant, and 2 had pre-existing medical conditions).
Participants were recruited with flyers and by referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Combination Therapy | Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed. Combination Therapy: Brief Behavioral Intervention The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. |
| FG001 | Standard Care Intervention | Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. Standard Care Intervention: Brief Behavioral Intervention The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| Intervention |
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| 1M Follow-Up |
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| 3M Follow-Up |
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| 6M Follow-Up |
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| 12M Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Combination Therapy | Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed. Combination Therapy: Brief Behavioral Intervention The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. |
| 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 | Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | This is the total number of participants in each arm that quit smoking at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
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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 | Tailored Combination Therapy | Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjust as need it Combination Therapy: Brief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw Pain | General disorders | Non-systematic Assessment |
Please note that verification of quitting was done in all participants before the pandemic. However, during the pandemic the follow up visits were not in person.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Jose Miguez | Florida International University | 561-839-0223 | mjmiguez@fiu.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 | Mar 24, 2016 | Dec 18, 2017 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2016 | Dec 16, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2018 | Jan 24, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Standard Care Intervention | Other | Brief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks |
|
| 6 months |
| Number of Participants With Verified Continuous Abstinence | Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 3 months |
| Prevalence of Side Effects-safety | Total number of self reported side effects from Baseline through 6 months. | Baseline-6 months |
| Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) - In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. | 12 months |
| Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 6 months |
| Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | 12 months |
| Prevalence of Side Effects-safety | Total number of self reported side effects from 6 through 12 months. | 6 through 12 months |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Standard Care Intervention | Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. Standard Care Intervention: Brief Behavioral Intervention The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Standard Care Intervention |
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. Standard Care Intervention: Brief Behavioral Intervention The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks |
|
|
| Primary | Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | This is the total number of participants in each arm that quit smoking at 6 months. However due to the pandemic we could not verified with biomarkers | Posted | Count of Units | Number of pts that quit | 6 months | Number of pts that quit | Number of pts that quit |
|
|
|
| Primary | Rates of Smoking Cessation | verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL). | This is the total number of participants in each arm that quit smoking at 12 months. | Posted | Count of Units | Number of pts that quit | 12 months | Number of pts that quit | Number of pts that quit |
|
|
|
| Secondary | Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) | Quality of Life change at 6 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) | Posted | Mean | Standard Deviation | score on a scale/change | 6 months |
|
|
|
| Secondary | Number of Participants With Verified Continuous Abstinence | Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | Verified abstinence at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Prevalence of Side Effects-safety | Total number of self reported side effects from Baseline through 6 months. | Total of number of participants in the Tailored & Standard arms. | Posted | Number | side effects | Baseline-6 months |
|
|
|
| Secondary | Change in Clinical Outcomes | The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) - In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. | Quality of Life change at 12 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) | Posted | Mean | Standard Deviation | score on a scale/change | 12 months |
|
|
|
| Secondary | Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | Verified abstinence at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants With Verified Continuous Abstinence | verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm | Verified abstinence at 12 months. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Prevalence of Side Effects-safety | Total number of self reported side effects from 6 through 12 months. | Total of number of participants in the Tailored & Standard arms. | Posted | Number | side effects | 6 through 12 months |
|
|
|
| 2 |
| 245 |
| 0 |
| 245 |
| 101 |
| 245 |
| EG001 | Standard Care Intervention | Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used. Standard Flavored gums will be used as needed for 10 weeks. Standard Care Intervention: Brief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks | 2 | 243 | 0 | 243 | 83 | 243 |
| Dry Mouth | General disorders | Non-systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Decrease Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Sleepiness | General disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vivid Dreams | Psychiatric disorders | Non-systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Body Aches | General disorders | Non-systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |