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| ID | Type | Description | Link |
|---|---|---|---|
| CCTS Research Scholar Award | Other Identifier | UTHealth |
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The purpose of this study is to identify a potential new treatment for smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide plus NRT plus counseling | Experimental | Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
|
| Placebo plus NRT plus counseling | Placebo Comparator | Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 6 weeks | |
| Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | 6 weeks |
| Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale | The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal. | 6 weeks |
| Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | 1 week |
| Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 7 weeks (1 week after end of treatment) | |
| Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luba Yammine, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29480848 | Background | Yammine L, Kosten TR, Cinciripini PM, Green CE, Meininger JC, Minnix JA, Newton TF. Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial. Medicine (Baltimore). 2018 Jan;97(2):e9567. doi: 10.1097/MD.0000000000009567. | |
| 33831213 | Derived | Yammine L, Green CE, Kosten TR, de Dios C, Suchting R, Lane SD, Verrico CD, Schmitz JM. Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2021 Aug 29;23(10):1682-1690. doi: 10.1093/ntr/ntab066. |
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1 participant in the exenatide arm did not receive exenatide, and 1 participant in the placebo arm did not receive placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Plus NRT Plus Counseling | Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks. NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. |
| FG001 | Placebo Plus NRT Plus Counseling | Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. Placebo: Normal saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Plus NRT Plus Counseling | Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks. NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. |
| 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 | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | Posted | Count of Participants | Participants | 6 weeks |
|
10 weeks
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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 | Exenatide Plus NRT Plus Counseling | Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks. NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site nodule | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luba Yammine, PhD, APRN, FNP-C, Associate Professor | The University of Texas Health Science Center at Houston | (713) 500-2005 | Luba.Yammine@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2017 | Jan 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D018149 | Glucose Intolerance |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D061485 | Tobacco Use Cessation Devices |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| NRT | Drug | Nicotine Patch (21mg) / 24 hours. |
|
|
| Counseling | Behavioral | Brief individual behavioral smoking cessation counseling. |
|
|
| Placebo | Drug | Normal saline. |
|
| 10 weeks (4 weeks after end of treatment) |
| Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | 7 weeks (1 week after end of treatment) |
| Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | 10 weeks (4 weeks after end of treatment) |
| BG001 | Placebo Plus NRT Plus Counseling | Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. Placebo: Normal saline. |
| 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 |
|
| Marital Status | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
|
| Cigarettes Smoked per Day | Mean | Standard Deviation | Cigarettes Smoked per Day |
|
| Years of Regular Smoking | Mean | Standard Deviation | years |
|
| Nicotine Dependence as Assessed by the Fagerstrom Test for Nicotine Dependence (FTND) | Total score ranges from 0-10. The higher the total Fagerström score, the more intense the physical dependence on nicotine. | Mean | Standard Deviation | score on a scale |
|
| Positive Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) | Score ranges from 10-50, with a higher score representing higher levels of Positive Affect. | Mean | Standard Deviation | score on a scale |
|
| Negative Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) | Score ranges from 10-50, with a higher score representing higher levels of Negative Affect. | Mean | Standard Deviation | score on a scale |
|
| Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-8) | Total score ranges from 0 to 24, with a higher score indicating greater depression. | Mean | Standard Deviation | score on a scale |
|
|
|
| Primary | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Primary | Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale | The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal. | Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Primary | Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected. | Posted | 1 week |
|
|
| Primary | Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected. | Posted | 3 weeks |
|
|
| Secondary | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent [self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)] at 6 weeks (end of treatment). | Posted | Count of Participants | Participants | 7 weeks (1 week after end of treatment) |
|
|
|
| Secondary | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent [self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)] at 6 weeks (end of treatment). | Posted | Count of Participants | Participants | 10 weeks (4 weeks after end of treatment) |
|
|
|
| Secondary | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | Data were not collected for 25 participants in the Exenatide plus NRT plus counseling arm and 32 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks (1 week after end of treatment) |
|
|
|
| Secondary | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. | Data were not collected for 30 participants in the Exenatide plus NRT plus counseling arm and 37 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (4 weeks after end of treatment) |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 4 |
| 41 |
| EG001 | Placebo Plus NRT Plus Counseling | Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling NRT: Nicotine Patch (21mg) / 24 hours. Counseling: Brief individual behavioral smoking cessation counseling. Placebo: Normal saline. | 0 | 41 | 0 | 41 | 1 | 41 |
| Pruritus at the site of nicotine patch application | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |