Trial Outcomes & Findings for Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families (NCT NCT04045964)

NCT ID: NCT04045964

Last Updated: 2024-12-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
• Results posted on: 2024-12-11

Participant Flow

Participant milestones

Measure	Motivational Advice and Free NRT nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Overall Study STARTED	16	16
Overall Study Intervention Visit(s)	15	16
Overall Study Follow up Visit 1	15	15
Overall Study Follow up Visit 2	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

Baseline characteristics by cohort

Measure	Motivational Advice and Free NRT n=16 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=16 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.	Total n=32 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	29.9 years STANDARD_DEVIATION 4.3 • n=7 Participants	30.2 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-America	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)

Outcome measures

Measure	Motivational Advice and Free NRT n=16 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.	13 Participants	—

PRIMARY outcome

Timeframe: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Outcome measures

Measure	Motivational Advice and Free NRT n=16 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=16 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Only current smokers (at Baseline) were assessed on this measure; 2 reported current smoking (Motivational Advice and Free NRT arm); 3 reported current smoking (Quitline Referral arm). A 4th Quitline participant began smoking after data were collected; therefore, number of cigarettes/day at baseline was not collected for this 4th participant.

Outcome measures

Measure	Motivational Advice and Free NRT n=2 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=3 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant <10 cigarettes per day	2 Participants	2 Participants
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant >=10 cigarettes per day	0 Participants	1 Participants

SECONDARY outcome

Timeframe: baseline

Population: Only current smokers were assessed for this measure. 12 partners of participants in the Motivational Advice and Free NRT arm reported current smoking, and 12 partners of participants in the Quitline Referral arm reported current smoking.

Outcome measures

Measure	Motivational Advice and Free NRT n=12 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=12 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner <10 cigarettes per day	6 Participants	7 Participants
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner >=10 cigarettes per day	6 Participants	5 Participants

SECONDARY outcome

Timeframe: baseline

Population: Only current smokers were assessed for this measure. 7 household members (other than participant or partner) living with participant in the Motivational Advice and Free NRT arm reported current smoking, and 6 household members (other than participant or partner) living with participant in the Quitline Referral arm reported current smoking.

Outcome measures

Measure	Motivational Advice and Free NRT n=7 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=6 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) <10 cigarettes per day	5 Participants	3 Participants
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) >=10 cigarettes per day	2 Participants	3 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #1 (about 2 weeks post-intervention)

Population: Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #1; i.e., 1 Quitline participant began smoking after baseline).

Outcome measures

Measure	Motivational Advice and Free NRT n=2 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=4 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts	2 Participants	1 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #2 (about 1 month post-intervention)

Population: Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #2; i.e., 1 Quitline participant began smoking after baseline).

Outcome measures

Measure	Motivational Advice and Free NRT n=2 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=4 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts	1 Participants	4 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #1 (about 2 weeks post-intervention)

Population: For each arm, 12 partners reported current smoking at baseline.

Outcome measures

Measure	Motivational Advice and Free NRT n=12 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=12 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts	5 Participants	0 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #2 (about 1 month post-intervention)

Population: For each arm, 12 partners reported current smoking at baseline.

Outcome measures

Measure	Motivational Advice and Free NRT n=12 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=12 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts	2 Participants	1 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #1 (about 2 weeks post-intervention)

Population: For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.

Outcome measures

Measure	Motivational Advice and Free NRT n=7 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=6 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at the time of follow-up visit #2 (about 1 month post-intervention)

Population: For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.

Outcome measures

Measure	Motivational Advice and Free NRT n=7 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=6 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Outcome measures

Measure	Motivational Advice and Free NRT n=16 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=16 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.	14 Participants	14 Participants

SECONDARY outcome

Timeframe: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)

Outcome measures

Measure	Motivational Advice and Free NRT n=16 Participants nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA).	Quitline Referral n=16 Participants Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.	14 Participants	14 Participants

Adverse Events

Motivational Advice and Free NRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Quitline Referral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Stotts, PhD

The University of Texas Health Science Center at Houston

Phone: (713) 500-7590

Email: Angela.L.Stotts@uth.tmc.edu

Results disclosure agreements

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