Trial Outcomes & Findings for UW-CTRI Triple Medication Smoking Cessation Study (NCT NCT02681510)

NCT ID: NCT02681510

Last Updated: 2017-10-11

Results Overview

Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-10-11

Participant Flow

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.

Participant milestones

Measure	Three Drug Intervention Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Overall Study STARTED	36
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Three Drug Intervention Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	9

Baseline Characteristics

UW-CTRI Triple Medication Smoking Cessation Study

Baseline characteristics by cohort

Measure	Three Drug Intervention n=36 Participants Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Age, Continuous	44 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized White	33 Participants n=5 Participants
Race/Ethnicity, Customized African-American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All study participants (N=36)

Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period

Outcome measures

Measure	Three Drug Intervention n=36 Participants Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Number of Participants With Adverse Events Vomiting	5 Participants
Number of Participants With Adverse Events Insomnia	27 Participants
Number of Participants With Adverse Events Vivid Dreams	26 Participants
Number of Participants With Adverse Events Nausea	23 Participants
Number of Participants With Adverse Events Mood Changes	15 Participants
Number of Participants With Adverse Events Dizziness	14 Participants
Number of Participants With Adverse Events Skin Rash	7 Participants
Number of Participants With Adverse Events Sweating	7 Participants
Number of Participants With Adverse Events Shortness of Breath	5 Participants
Number of Participants With Adverse Events Chest Tightness	4 Participants
Number of Participants With Adverse Events Angina	1 Participants

SECONDARY outcome

Timeframe: Week 12

Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)

Outcome measures

Measure	Three Drug Intervention n=36 Participants Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms	9.1 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Week 12

Population: All study participants (N=36)

Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)

Outcome measures

Measure	Three Drug Intervention n=36 Participants Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking	9.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Week 12

Population: All study participants (N=36)

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

Outcome measures

Measure	Three Drug Intervention n=36 Participants Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Number of Participants Who Reported Quitting at the End of Treatment	21 Participants

Adverse Events

Three Drug Intervention

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Three Drug Intervention n=36 participants at risk Varenicline, nicotine patch and nicotine lozenge for 12 weeks
Psychiatric disorders Insomnia	75.0% 27/36 • Number of events 27 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Psychiatric disorders Vivid Dreams	72.2% 26/36 • Number of events 26 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Gastrointestinal disorders Nausea	63.9% 23/36 • Number of events 23 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Psychiatric disorders Mood Changes	41.7% 15/36 • Number of events 15 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Nervous system disorders Dizziness	38.9% 14/36 • Number of events 14 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Skin and subcutaneous tissue disorders Skin Rash	19.4% 7/36 • Number of events 7 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
General disorders Sweating	19.4% 7/36 • Number of events 7 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Respiratory, thoracic and mediastinal disorders Shortness of Breath	13.9% 5/36 • Number of events 5 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Gastrointestinal disorders Vomiting	13.9% 5/36 • Number of events 5 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Cardiac disorders Chest Tightness	11.1% 4/36 • Number of events 4 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).
Cardiac disorders Angina	2.8% 1/36 • Number of events 1 • 12 weeks The AE assessment specifically queried the presence or absence of: chest tightness, angina, dizziness, dreams, insomnia, mood changes, nausea, skin rash, sweating, shortness of breath, and vomiting. The severity of each AE was graded as: mild (no interference with daily activities, no medications needed to treat symptom); moderate (some interference with daily activities, over-the-counter medications needed); severe (unable to perform daily activity, prescription medication needed).

Additional Information

Stevens S. Smith, Ph.D.

Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health

Phone: 6082627563

Email: sss@ctri.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place