Trial Outcomes & Findings for Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers (NCT NCT02244918)

Last Updated: 2019-01-09

Results Overview

Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

278 participants

Primary outcome timeframe

Week 12

Results posted on

2019-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Counseling Plus Nicotine Replacement Therapy Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Overall Study STARTED	185	93
Overall Study Week 12	160	83
Overall Study COMPLETED	185	93
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.	Total n=278 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 1.6 • n=5 Participants	49 years STANDARD_DEVIATION 11.8 • n=7 Participants	48.7 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	47 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	46 Participants n=7 Participants	137 Participants n=5 Participants
Race/Ethnicity, Customized African American, Non-Hispanic	185 Participants n=5 Participants	93 Participants n=7 Participants	278 Participants n=5 Participants
Region of Enrollment United States	185 participants n=5 Participants	93 participants n=7 Participants	278 participants n=5 Participants
Cohabitation Status, Married or living with a partner	48 Participants n=5 Participants	17 Participants n=7 Participants	65 Participants n=5 Participants
Employed Full-time	45 Participants n=5 Participants	29 Participants n=7 Participants	74 Participants n=5 Participants
Education level of less than High School graduate	27 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants
Has health insurance	146 Participants n=5 Participants	67 Participants n=7 Participants	213 Participants n=5 Participants
< or = 100% Poverty Level	79 Participants n=5 Participants	38 Participants n=7 Participants	117 Participants n=5 Participants
Own a Home	25 Participants n=5 Participants	7 Participants n=7 Participants	32 Participants n=5 Participants
BMI	31.3 kg/m^2 STANDARD_DEVIATION 8.7 • n=5 Participants	31.7 kg/m^2 STANDARD_DEVIATION 9.8 • n=7 Participants	31.5 kg/m^2 STANDARD_DEVIATION 9.1 • n=5 Participants
Days smoked cigarettes in the last 30	23.2 days STANDARD_DEVIATION 8.0 • n=5 Participants	22.8 days STANDARD_DEVIATION 8.0 • n=7 Participants	23.1 days STANDARD_DEVIATION 8.0 • n=5 Participants
Number of cigarettes used on days smoked	4.8 cigarettes STANDARD_DEVIATION 3.6 • n=5 Participants	4.4 cigarettes STANDARD_DEVIATION 3.2 • n=7 Participants	4.7 cigarettes STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Smoking Abstinence	21 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 26

Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Smoking Abstinence	13 Participants	6 Participants

SECONDARY outcome

Timeframe: Weeks 0, 26

Population: Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit.

Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Concentration of Urinary Cotinine Baseline Nicotine Exposure	1538.3 ng/ml Standard Deviation 1622.0	1905.3 ng/ml Standard Deviation 1695.3
Concentration of Urinary Cotinine Week 26 Nicotine Exposure	1513.2 ng/ml Standard Deviation 1779.0	1649.3 ng/ml Standard Deviation 1443.9

SECONDARY outcome

Timeframe: Weeks 0, 12

Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.

Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) Baseline Carcinogen Exposure	100.9 pg/ml Standard Deviation 121.0	97.1 pg/ml Standard Deviation 97.8
Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol) Week 12 Carcinogen Exposure	47.6 pg/ml Standard Deviation 55.2	49.3 pg/ml Standard Deviation 47.3

SECONDARY outcome

Timeframe: Week 0-26

Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.

Number of days abstinent from baseline through week 26.

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Total Days Abstinent Week 12 days abstinent from all tobacco	19.8 days abstinent in the past 30 days Standard Deviation 10.7	14.8 days abstinent in the past 30 days Standard Deviation 11.1
Total Days Abstinent Baseline days abstinent from all tobacco	10.3 days abstinent in the past 30 days Standard Deviation 6.4	10.4 days abstinent in the past 30 days Standard Deviation 6.4
Total Days Abstinent Week 4 days abstinent from all tobacco	17.4 days abstinent in the past 30 days Standard Deviation 9.0	12.8 days abstinent in the past 30 days Standard Deviation 9.2
Total Days Abstinent Week 8 days abstinent from all tobacco	20.8 days abstinent in the past 30 days Standard Deviation 9.0	19.8 days abstinent in the past 30 days Standard Deviation 10.7
Total Days Abstinent Week 26 days abstinent from all tobacco	19.2 days abstinent in the past 30 days Standard Deviation 11.2	15.1 days abstinent in the past 30 days Standard Deviation 11.2

SECONDARY outcome

Timeframe: Weeks 0-26

Population: The number of participants analyzed at follow-up time-points reflects only those who returned at that point.

Cigarettes used in the past 30 days from baseline through week 26

Outcome measures

Outcome measures
Measure	Counseling Plus Nicotine Replacement Therapy n=185 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 Participants Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Cigarettes Used Baseline	100.4 Cigarettes used in the past 30 days Standard Deviation 102.1	85.8 Cigarettes used in the past 30 days Standard Deviation 72.6
Cigarettes Used Week 4	43.2 Cigarettes used in the past 30 days Standard Deviation 58.5	57.9 Cigarettes used in the past 30 days Standard Deviation 51.8
Cigarettes Used Week 8	30.9 Cigarettes used in the past 30 days Standard Deviation 52.3	53.3 Cigarettes used in the past 30 days Standard Deviation 64.3
Cigarettes Used Week 12	37.1 Cigarettes used in the past 30 days Standard Deviation 69.4	49.0 Cigarettes used in the past 30 days Standard Deviation 56.6
Cigarettes Used Week 26	46.9 Cigarettes used in the past 30 days Standard Deviation 81.0	48.7 Cigarettes used in the past 30 days Standard Deviation 57.4

Adverse Events

Counseling Plus Nicotine Replacement Therapy

Serious events: 0 serious events

Other events: 161 other events

Deaths: 0 deaths

Counseling

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Nicole Nollen

University of Kansas Medical Center

Phone: 913-588-3784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Counseling Plus Nicotine Replacement Therapy n=185 participants at risk Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice. Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.	Counseling n=93 participants at risk Participants will attend 5 smoking cessation counseling sessions over 12 weeks.
Respiratory, thoracic and mediastinal disorders Breathing Problems	31.9% 59/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	30.1% 28/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Blisters in the mouth, increased saliva, or other problems with the mouth, tooth or jaw	31.9% 59/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	21.5% 20/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Bowel changes like constipation or diarrhea	37.8% 70/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	38.7% 36/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Changes in taste	56.2% 104/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	48.4% 45/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Endocrine disorders Cold Sweats or increased sweating	38.9% 72/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	36.6% 34/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Psychiatric disorders Difficulty concentrating or confusion.mental weakness	34.1% 63/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	36.6% 34/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Ear and labyrinth disorders Disturbed hearing or vision	20.0% 37/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	25.8% 24/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Ear and labyrinth disorders Dizziness	27.6% 51/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	22.6% 21/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
General disorders Headache	47.0% 87/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	47.3% 44/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Heartburn, indigestion, hiccups or burping	47.6% 88/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	46.2% 43/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Cardiac disorders Irregular or fast heart beat	21.6% 40/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	21.5% 20/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
General disorders Irritability	56.8% 105/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	67.7% 63/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Nausea or vomiting	28.6% 53/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	18.3% 17/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Nervous system disorders Nervous, restless, anxious	55.7% 103/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	60.2% 56/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Skin and subcutaneous tissue disorders Redness/swelling/rash/irritation on the skin	19.5% 36/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	6.5% 6/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
General disorders Sleeping Problems	53.0% 98/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	60.2% 56/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Sore throat	23.2% 43/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	20.4% 19/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
Gastrointestinal disorders Stomach cramps or pains	21.6% 40/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	0.00% 0/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.
General disorders Tiredness/fatigue	58.9% 109/185 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.	72.0% 67/93 • Adverse events were collected for 12 weeks. At each assessment point, participants were asked to report any new or worsening symptoms.