A Phase 4 interventional study of Counseling and combination NRT in Smoking Cessation, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
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.
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.).
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.
Behavioral: Counseling · Drug: combination NRT
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.
Behavioral: Counseling · Drug: combination NRT
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
Both groups will receive combination NRT to help with smoking cessation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline through 13 weeks
| Milestone | In Vivo | Standard of Care |
|---|---|---|
| Started | 41 | 39 |
| Completed | 23 | 29 |
| Not completed | 18 | 10 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Moved out of state | 1 | 1 |
| Withdrew: Already enrolled in another smoking cessation study providing nrt | 1 | 0 |
| Withdrew: No show to appointments after baseline through week 5 | 8 | 1 |
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.
| Participants | In Vivo | Standard of Care |
|---|---|---|
| Participant retention rate | 23 | 29 |
| Participant attrition rate | 18 | 10 |
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.
| participants screened per week | Total Participants Screened |
|---|---|
| Rate of Recruitment | 5.84 |
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.
| participants enrolled per week | Total Participants Enrolled |
|---|---|
| Rate of Enrollment | 1.43 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Satisfaction | 67.70 ± 3.81 | 69.20 ± 4.81 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Satisfaction | 65.21 ± 10.67 | 66.39 ± 5.91 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Satisfaction | 66.35 ± 9.82 | 65.62 ± 10.57 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Expectancies at Baseline | 23.29 ± 7.68 | 21.23 ± 10.58 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Credibility | 1.43 ± 3.67 | 0.84 ± 5.05 |
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.
| score on a scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Credibility | -0.74 ± 5.12 | 0.08 ± 3.78 |
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.
| score on scale | In Vivo | Standard of Care |
|---|---|---|
| Treatment Credibility | -0.26 ± 5.22 | -1.64 ± 5.47 |
Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
| Participants | In Vivo | Standard of Care |
|---|---|---|
| No patch doses missed | 22 | 26 |
| No NRT doses missed | 23 | 27 |
Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
| Participants | In Vivo | Standard of Care |
|---|---|---|
| No patch doses missed | 23 | 24 |
| No NRT doses missed | 26 | 33 |
Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
| Participants | In Vivo | Standard of Care |
|---|---|---|
| No patch doses missed | 18 | 21 |
| No NRT doses missed | 17 | 22 |
Collected over Baseline through 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In Vivo | 0/41 (0%) | 1/41 (2.4%) | 15/41 (36.6%) |
| Standard of Care | 0/39 (0%) | 1/39 (2.6%) | 2/39 (5.1%) |
| Event | In Vivo | Standard of Care |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/41 | 1/39 |
| Severe DepressionPsychiatric disorders | 0/41 | 1/39 |
| Undisclosed VirusGeneral disorders | 1/41 | 0/39 |
| Event | In Vivo | Standard of Care |
|---|---|---|
| Vivid Dreams/NightmaresGeneral disorders | 4/41 | 0/39 |
| VomitingGastrointestinal disorders | 4/41 | 0/39 |
| NauseaGastrointestinal disorders | 3/41 | 0/39 |
| Throat IrritationRespiratory, thoracic and mediastinal disorders | 2/41 | 0/39 |
| Ear PainEar and labyrinth disorders | 2/41 | 0/39 |
| Excessive SneezingRespiratory, thoracic and mediastinal disorders | 2/41 | 0/39 |
| RashSkin and subcutaneous tissue disorders | 2/41 | 1/39 |
| HeadacheGeneral disorders | 2/41 | 1/39 |
| Burning Mouth/ThroatRespiratory, thoracic and mediastinal disorders | 1/41 | 1/39 |
| Excessive CoughingRespiratory, thoracic and mediastinal disorders | 1/41 | 1/39 |
| Age, Categorical(Participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 39 | 80 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| Female | 18 | 12 | 30 |
| Male | 23 | 27 | 50 |
| Ethnicity (NIH/OMB)(Participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 39 | 39 | 78 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 23 | 45 |
| White | 18 | 15 | 33 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| United States | 41 | 39 | 80 |
| Quitting Smoking Behaviors at Baseline(Participants) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| Thinking of quitting smoking in the next month | 24 | 21 | 45 |
| Thinking of quitting smoking within the next 6 months | 17 | 14 | 31 |
| Tried NRT to help quit smoking before? | 13 | 16 | 29 |
| Tried therapy to help quit smoking before? | 2 | 1 | 3 |
| Tried self-help materials to help quit before? | 1 | 4 | 5 |
| Tried hypnosis to help quit smoking before? | 2 | 0 | 2 |
| Tried medication to help quit smoking before? | 4 | 7 | 11 |
| Tried e-cigarettes to help quit smoking before? | 12 | 12 | 24 |
| Are any medical problems worsened by smoking? | 4 | 10 | 14 |
| Live with people who smoke? | 29 | 29 | 58 |
| Not thinking of quitting smoking | 0 | 4 | 4 |
| Cigarettes Per Day at Baseline(cigarettes per day) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| Mean | 19.46 ± 11.05 | 18.36 ± 9.26 | 18.93 ± 10.17 |
| Carbon Monoxide (CO) Level at Baseline(parts per million (ppm) of CO) | In Vivo | Standard of Care | Total |
|---|---|---|---|
| Mean | 18.56 ± 11.28 | 18.23 ± 8.02 | 18.40 ± 9.76 |
3 further baseline measures are reported on the registry.
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University of Alabama at Birmingham