Smoking Cessation
Conditions
Brief summary
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.
Detailed description
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.
Interventions
BEHAVIORALCounseling
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
DRUGcombination NRT
Both groups will receive combination NRT to help with smoking cessation
Sponsors
National Institute on Drug Abuse (NIDA)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In vivo or standard of care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participant Retention | From baseline through 4 months | 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. |
| Rate of Recruitment | 56 weeks | 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. |
| Rate of Enrollment | 56 weeks | 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. |
| Treatment Satisfaction | 5 weeks | 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. |
| Treatment Expectancies at Baseline | Assessed 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. |
| Treatment Credibility | 5 weeks | 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. |
| Number of Participants With Medication Adherence at Week 6 | From baseline through 6 weeks | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. |
| Number of Participants With Medication Adherence at Week 9 | From baseline through 9 weeks | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. |
| Number of Participants With Medication Adherence at Week 13 | From baseline through 13 weeks | Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| 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 | 39 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Already enrolled in another smoking cessation study providing NRT | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Moved out of state | 1 | 1 |
| Overall Study | No show to appointments after baseline through Week 5 | 8 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Standard of Care | Total | In Vivo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 80 Participants | 41 Participants |
| Carbon Monoxide (CO) Level at Baseline | 18.23 parts per million (ppm) of CO STANDARD_DEVIATION 8.02 | 18.40 parts per million (ppm) of CO STANDARD_DEVIATION 9.76 | 18.56 parts per million (ppm) of CO STANDARD_DEVIATION 11.28 |
| Cigarettes Per Day at Baseline | 18.36 cigarettes per day STANDARD_DEVIATION 9.26 | 18.93 cigarettes per day STANDARD_DEVIATION 10.17 | 19.46 cigarettes per day STANDARD_DEVIATION 11.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 78 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Intensity of Nicotine Dependency at Baseline | 6.0 scores on a scale STANDARD_DEVIATION 1.84 | 6.26 scores on a scale STANDARD_DEVIATION 1.79 | 6.49 scores on a scale STANDARD_DEVIATION 1.79 |
| Number of Years Smoked Reported at Baseline | 28.92 years STANDARD_DEVIATION 10.82 | 26.79 years STANDARD_DEVIATION 11.13 | 24.73 years STANDARD_DEVIATION 11.18 |
| Quitting Smoking Behaviors at Baseline Are any medical problems worsened by smoking? | 10 Participants | 14 Participants | 4 Participants |
| Quitting Smoking Behaviors at Baseline Live with people who smoke? | 29 Participants | 58 Participants | 29 Participants |
| Quitting Smoking Behaviors at Baseline Not thinking of quitting smoking | 4 Participants | 4 Participants | 0 Participants |
| Quitting Smoking Behaviors at Baseline Thinking of quitting smoking in the next month | 21 Participants | 45 Participants | 24 Participants |
| Quitting Smoking Behaviors at Baseline Thinking of quitting smoking within the next 6 months | 14 Participants | 31 Participants | 17 Participants |
| Quitting Smoking Behaviors at Baseline Tried e-cigarettes to help quit smoking before? | 12 Participants | 24 Participants | 12 Participants |
| Quitting Smoking Behaviors at Baseline Tried hypnosis to help quit smoking before? | 0 Participants | 2 Participants | 2 Participants |
| Quitting Smoking Behaviors at Baseline Tried medication to help quit smoking before? | 7 Participants | 11 Participants | 4 Participants |
| Quitting Smoking Behaviors at Baseline Tried NRT to help quit smoking before? | 16 Participants | 29 Participants | 13 Participants |
| Quitting Smoking Behaviors at Baseline Tried self-help materials to help quit before? | 4 Participants | 5 Participants | 1 Participants |
| Quitting Smoking Behaviors at Baseline Tried therapy to help quit smoking before? | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 45 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 33 Participants | 18 Participants |
| Region of Enrollment United States | 39 participants | 80 participants | 41 participants |
| Sex: Female, Male Female | 12 Participants | 30 Participants | 18 Participants |
| Sex: Female, Male Male | 27 Participants | 50 Participants | 23 Participants |
| Smoking Urges at Baseline | 44.36 units on a scale STANDARD_DEVIATION 16.58 | 45.24 units on a scale STANDARD_DEVIATION 15.98 | 46.07 units on a scale STANDARD_DEVIATION 15.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 15 / 41 | 2 / 39 |
| serious Total, serious adverse events | 1 / 41 | 1 / 39 |
Outcome results
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.
Time frame: From baseline through 13 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In Vivo | Number of Participants With Medication Adherence at Week 13 | No patch doses missed | 18 Participants |
| In Vivo | Number of Participants With Medication Adherence at Week 13 | No NRT doses missed | 17 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 13 | No patch doses missed | 21 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 13 | No NRT doses missed | 22 Participants |
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.
Time frame: From baseline through 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In Vivo | Number of Participants With Medication Adherence at Week 6 | No NRT doses missed | 23 Participants |
| In Vivo | Number of Participants With Medication Adherence at Week 6 | No patch doses missed | 22 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 6 | No patch doses missed | 26 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 6 | No NRT doses missed | 27 Participants |
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.
Time frame: From baseline through 9 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In Vivo | Number of Participants With Medication Adherence at Week 9 | No patch doses missed | 23 Participants |
| In Vivo | Number of Participants With Medication Adherence at Week 9 | No NRT doses missed | 26 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 9 | No patch doses missed | 24 Participants |
| Standard of Care | Number of Participants With Medication Adherence at Week 9 | No NRT doses missed | 33 Participants |
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.
Time frame: 56 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Vivo | Rate of Enrollment | 1.43 participants enrolled per week |
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.
Time frame: From baseline through 4 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In Vivo | Rate of Participant Retention | Participant retention rate | 23 Participants |
| In Vivo | Rate of Participant Retention | Participant attrition rate | 18 Participants |
| Standard of Care | Rate of Participant Retention | Participant retention rate | 29 Participants |
| Standard of Care | Rate of Participant Retention | Participant attrition rate | 10 Participants |
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.
Time frame: 56 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Vivo | Rate of Recruitment | 5.84 participants screened per week |
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.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Credibility | 1.43 score on a scale | Standard Deviation 3.67 |
| Standard of Care | Treatment Credibility | 0.84 score on a scale | Standard Deviation 5.05 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Credibility | -0.74 score on a scale | Standard Deviation 5.12 |
| Standard of Care | Treatment Credibility | 0.08 score on a scale | Standard Deviation 3.78 |
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Credibility | -0.26 score on scale | Standard Deviation 5.22 |
| Standard of Care | Treatment Credibility | -1.64 score on scale | Standard Deviation 5.47 |
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.
Time frame: Assessed at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Expectancies at Baseline | 23.29 score on a scale | Standard Deviation 7.68 |
| Standard of Care | Treatment Expectancies at Baseline | 21.23 score on a scale | Standard Deviation 10.58 |
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Satisfaction | 66.35 score on a scale | Standard Deviation 9.82 |
| Standard of Care | Treatment Satisfaction | 65.62 score on a scale | Standard Deviation 10.57 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Satisfaction | 65.21 score on a scale | Standard Deviation 10.67 |
| Standard of Care | Treatment Satisfaction | 66.39 score on a scale | Standard Deviation 5.91 |
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.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Vivo | Treatment Satisfaction | 67.70 score on a scale | Standard Deviation 3.81 |
| Standard of Care | Treatment Satisfaction | 69.20 score on a scale | Standard Deviation 4.81 |