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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA043346 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.
Adherence is a critical target for successful smoking cessation, with good adherence associated with a three-fold increase in cessation rates relative to poor adherence. Psychoeducational interventions focused on increasing adherence to NRT do not result in behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with practice quit attempts (PQAs), are based on learning theory models of behavioral change and have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to psychoeducation or motivational interventions. However, nicotine sampling still relies of the participant using NRT outside of session, which may not occur. Providing an experiential intervention in which the NRT is sampled and any problems with NRT reframed during the session may provide a powerful learning experience that can increase in home sampling with PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This may be particularly relevant for low-income smokers who hold more negative views of NRT, have lower health literacy, and are less likely to use medication during cessation attempts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In vivo | Experimental | Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt. |
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| Standard of care | Active Comparator | Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participant Retention | Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed. | From baseline through 4 months |
| Rate of Recruitment | The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study. | 56 weeks |
| Rate of Enrollment | The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study. | 56 weeks |
| Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. | 5 weeks |
| Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. |
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Inclusion Criteria:
a) 18 years or older; b) qualifying as low income (as defined by making <150% above the poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least 5 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than 8 ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large >50% African-American who average <10 CPD compared to Whites who average ~15 CPD.; and d) English speaking.
Exclusion Criteria:
a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or nursing (all women will be required to use an acceptable form of contraception); c) Currently enrolled in a smoking cessation treatment program, using NRT products, or prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included); or i) Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).
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| Name | Affiliation | Role |
|---|---|---|
| Karen Cropsey, PsyD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38446860 | Derived | Sisson ML, Gajos JM, Wolford-Clevenger C, Chichester KR, Hawes ES, Hill SV, Shelton RC, Hendricks PS, Businelle MS, Carpenter MJ, Cropsey KL. Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes. J Addict Med. 2024 Jul-Aug 01;18(4):397-403. doi: 10.1097/ADM.0000000000001298. Epub 2024 Mar 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | In Vivo | Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
| FG001 | Standard of Care | Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In Vivo | Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race. |
| 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 | Rate of Participant Retention | Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed. | Posted | Count of Participants | Participants | From baseline through 4 months |
|
Baseline through 4 months
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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 | In Vivo | Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant was hospitalized for treatment for pneumonia between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred while using the nicotine nasal spray. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Cropsey | University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology | 205-975-4204 | kcropsey@uabmc.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 | May 19, 2021 | Oct 21, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Oct 21, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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In vivo or standard of care
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| combination NRT | Drug | Both groups will receive combination NRT to help with smoking cessation |
|
| 13 weeks |
| Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. | 4 months |
| Treatment Expectancies at Baseline | Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome. | Assessed at baseline |
| Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | 5 weeks |
| Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | 13 weeks |
| Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | 4 months |
| Number of Participants With Medication Adherence at Week 6 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | From baseline through 6 weeks |
| Number of Participants With Medication Adherence at Week 9 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | From baseline through 9 weeks |
| Number of Participants With Medication Adherence at Week 13 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | From baseline through 13 weeks |
| Moved out of state |
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| Already enrolled in another smoking cessation study providing NRT |
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| No show to appointments after baseline through Week 5 |
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| BG001 | Standard of Care | Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Quitting Smoking Behaviors at Baseline | Quitting smoking behaviors was measured using the Smoking History Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used as a demographic form to collect information about participant history of smoking behaviors and quitting smoking behaviors. | Count of Participants | Participants |
|
| Cigarettes Per Day at Baseline | Mean | Standard Deviation | cigarettes per day |
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| Carbon Monoxide (CO) Level at Baseline | Mean | Standard Deviation | parts per million (ppm) of CO |
|
| Number of Years Smoked Reported at Baseline | Mean | Standard Deviation | years |
|
| Intensity of Nicotine Dependency at Baseline | Fagerstrom Test for Nicotine Dependence (FTND) is a standardized instrument for assessing the intensity of physical addiction to nicotine. The FTND contains six items containing yes/no items and multiple choice items. Yes/no items are scored from 0 to 1, and the multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0 to 10. The lowest score on the FTND is a 0, and the highest score on the FTND is a 10. The higher the total FTND score, the worse the participants' outcome is since this indicates a greater intensity of physical dependency on nicotine. | Mean | Standard Deviation | scores on a scale |
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| Smoking Urges at Baseline | Participant smoking urges were assessed using the Questionnaire of Smoking Urges (QSU), which is a standardized assessment used to determine level of cravings for smoking. There are ten items in this assessment, and each item was rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The items are summed to determine a total score for level of smoking urges. The lowest score on this scale is 10, and the highest score on the scale is 70. Higher scores indicate worse outcomes for the participant since higher scores indicate more intense smoking urges. | Mean | Standard Deviation | units on a scale |
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| OG001 | Standard of Care | Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation |
|
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| Primary | Rate of Recruitment | The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study. | Posted | Number | participants screened per week | 56 weeks |
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| Primary | Rate of Enrollment | The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study. | Posted | Number | participants enrolled per week | 56 weeks |
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| Primary | Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Primary | Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
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| Primary | Treatment Satisfaction | Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
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| Primary | Treatment Expectancies at Baseline | Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline |
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|
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| Primary | Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Primary | Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
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| Primary | Treatment Credibility | Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome. | Posted | Mean | Standard Deviation | score on scale | 4 months |
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| Primary | Number of Participants With Medication Adherence at Week 6 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | Posted | Count of Participants | Participants | From baseline through 6 weeks |
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| Primary | Number of Participants With Medication Adherence at Week 9 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | Posted | Count of Participants | Participants | From baseline through 9 weeks |
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| Primary | Number of Participants With Medication Adherence at Week 13 | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. | Posted | Count of Participants | Participants | From baseline through 13 weeks |
|
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| 0 |
| 41 |
| 1 |
| 41 |
| 15 |
| 41 |
| EG001 | Standard of Care | Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt. Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking combination NRT: Both groups will receive combination NRT to help with smoking cessation | 0 | 39 | 1 | 39 | 2 | 39 |
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| Severe Depression | Psychiatric disorders | Systematic Assessment | Participant was admitted to inpatient psychiatric treatment for symptoms of depression between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks. |
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| Undisclosed Virus | General disorders | Systematic Assessment | Participant reported being hospitalized to be treated for an undisclosed virus between sessions. |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred while using the nicotine nasal spray. |
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| Nasal Drainage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred while using the nicotine nasal spray. |
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| Ear Pain | Ear and labyrinth disorders | Systematic Assessment | Occurred while using the nicotine nasal spray. 1 instance occurred without any NRT use (not related to study medication). |
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| Excessive Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred while using the nicotine nasal spray. |
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| Nicotine Dosage Too Strong | General disorders | Systematic Assessment | Occurred while using the nicotine gum. |
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| Vivid Dreams/Nightmares | General disorders | Systematic Assessment | Occurred while using either the 21 mg patch or 14 mg patch. |
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| Burning Mouth/Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred while using the 2 mg or 4 mg nicotine lozenges/gum or the nicotine inhaler |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Occurred while using the 21 mg or 14 mg nicotine patch. 1 participant reported an unrelated neck rash while using the 4 mg and 2 mg nicotine lozenges. |
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| Excessive Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred when using the nicotine inhaler. |
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| Headache | General disorders | Systematic Assessment | Occurred when using the nicotine patches and nicotine lozenges in combination, as well as when using the nicotine inhaler. |
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| Stomach ache | Gastrointestinal disorders | Systematic Assessment | Occurred when using the nicotine patches and nicotine lozenges in combination. |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | Occurred after using the nicotine patch, nicotine inhaler, nicotine gum, and nicotine lozenges. |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Occurred when using the nicotine replacement products. |
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| Nasal Burning | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred when using the nicotine nasal spray. |
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| Nasal Tingling | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred when using the nicotine nasal spray. |
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| Jitteriness | General disorders | Systematic Assessment | Occurred when using the nicotine inhaler. |
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| Nasal Blistering | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred when using the nicotine nasal spray. |
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| Watering Eyes | Eye disorders | Systematic Assessment | Occurred when using the nicotine nasal spray. |
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| Increased Heart Rate | General disorders | Systematic Assessment | Occurred when using the nicotine nasal spray. |
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| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | A participant reported being treated for an upper respiratory infection. This infection was unrelated to the participant using any study NRT medication. |
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| Tooth Pain | General disorders | Systematic Assessment | Participant reported tooth pain during session that was not related to using the study NRT medication. |
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| D005159 | Health Care Facilities Workforce and Services |