Smoking
Conditions
Keywords
medication tolerability
Brief summary
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.
Detailed description
Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.
Interventions
DRUGVarenicline
Standard FDA approved 12 weeks of treatment with Varenicline
Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch
DRUGNicotine Mini
Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \>17 years; * \>=5 cigarettes/day for the previous 6 months; * alveolar CO \>= 6 ppm; able to read, write and speak English; * planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline; * if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study; * free of medical contraindications to NRT and varenicline; and, * if participant is a woman of childbearing potential, using an approved method of birth control during treatment.
Exclusion criteria
* Current diagnosis of/treatment for psychosis or bipolar disorder; * suicidal ideation within the past 12 months; any history of suicide attempts; \* significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past; * use of any investigational drugs in the previous 30 days. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 12 weeks | Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms | Week 12 | Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction) |
| Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking | Week 12 | Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction) |
| Number of Participants Who Reported Quitting at the End of Treatment | Week 12 | Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via Facebook ads contextually tagged to appear only to adults in the Madison, WI area who had liked or posted about smoking.
Participants by arm
| Arm | Count |
|---|---|
| Three Drug Intervention Varenicline, nicotine patch and nicotine lozenge for 12 weeks | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Three Drug Intervention |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized African-American | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 33 Participants |
| Region of Enrollment United States | 36 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 35 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Number of Participants With Adverse Events
Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period
Time frame: 12 weeks
Population: All study participants (N=36)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Three Drug Intervention | Number of Participants With Adverse Events | Dizziness | 14 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Skin Rash | 7 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Sweating | 7 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Shortness of Breath | 5 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Vomiting | 5 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Chest Tightness | 4 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Angina | 1 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Insomnia | 27 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Vivid Dreams | 26 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Nausea | 23 Participants |
| Three Drug Intervention | Number of Participants With Adverse Events | Mood Changes | 15 Participants |
Secondary
Number of Participants Who Reported Quitting at the End of Treatment
Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call
Time frame: Week 12
Population: All study participants (N=36)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three Drug Intervention | Number of Participants Who Reported Quitting at the End of Treatment | 21 Participants |
Secondary
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms
Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Drug Intervention | Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms | 9.1 units on a scale | Standard Deviation 1.2 |
Secondary
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking
Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)
Time frame: Week 12
Population: All study participants (N=36)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Drug Intervention | Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking | 9.2 units on a scale | Standard Deviation 1.4 |