Trial Outcomes & Findings for Tobacco Intervention in Primary Care Treatment Opportunities for Providers (NCT NCT02096029)

NCT ID: NCT02096029

Last Updated: 2019-08-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1278 participants
• Primary outcome timeframe: From study enrollment through end of six-month follow up
• Results posted on: 2019-08-07

Participant Flow

Of 1,278 Enrolled: 32 Individuals later found to be ineligible 1 person missing contact info 1,245 = Final Intent to Treat Sample

Participant milestones

Measure	Standard Care Ask, Advise, Refer (physician brief advice)	Standard Care + Nicotine Replacement Therapy (NRT) 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
Overall Study STARTED	652	593
Overall Study COMPLETED	652	593
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tobacco Intervention in Primary Care Treatment Opportunities for Providers

Baseline characteristics by cohort

Measure	Standard Care n=652 Participants Ask, Advise, Refer (physician brief advice)	Standard Care + Nicotine Replacement Therapy (NRT) n=593 Participants 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch	Total n=1245 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 13.6 • n=5 Participants	50.4 years STANDARD_DEVIATION 13.4 • n=7 Participants	50.7 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	365 Participants n=5 Participants	391 Participants n=7 Participants	756 Participants n=5 Participants
Sex: Female, Male Male	287 Participants n=5 Participants	202 Participants n=7 Participants	489 Participants n=5 Participants
Race/Ethnicity, Customized White or African American · White	346 Participants n=5 Participants	433 Participants n=7 Participants	779 Participants n=5 Participants
Race/Ethnicity, Customized White or African American · African American	306 Participants n=5 Participants	160 Participants n=7 Participants	466 Participants n=5 Participants
Heaviness of Smoking Index	2.6 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	2.7 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Motivation to Quit	6.2 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	6.4 units on a scale STANDARD_DEVIATION 3.6 • n=7 Participants	6.3 units on a scale STANDARD_DEVIATION 3.65 • n=5 Participants

PRIMARY outcome

Timeframe: From study enrollment through end of six-month follow up

Outcome measures

Measure	Standard Care + Nicotine Replacement Therapy (NRT) n=593 Participants 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch	Standard Care n=652 Participants Ask, Advise, Refer (physician brief advice)
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence	12 percentage of participants	8 percentage of participants

SECONDARY outcome

Timeframe: From study enrollment through end of six-month follow up

Outcome measures

Measure	Standard Care + Nicotine Replacement Therapy (NRT) n=593 Participants 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch	Standard Care n=652 Participants Ask, Advise, Refer (physician brief advice)
Any Self-defined Attempt to Stop Smoking Cigarettes	48 percentage of participants	45 percentage of participants

SECONDARY outcome

Timeframe: From study enrollment through end of six-month follow up

Outcome measures

Measure	Standard Care + Nicotine Replacement Therapy (NRT) n=593 Participants 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch	Standard Care n=652 Participants Ask, Advise, Refer (physician brief advice)
Use of Any Smoking Cessation Medication	25 percentage of participants	14 percentage of participants

Adverse Events

Standard Care

Serious events: 20 serious events

Other events: 289 other events

Deaths: 3 deaths

Standard Care + Nicotine Replacement Therapy (NRT)

Serious events: 9 serious events

Other events: 276 other events

Deaths: 1 deaths

Serious adverse events

Measure	Standard Care n=652 participants at risk Ask, Advise, Refer (physician brief advice)	Standard Care + Nicotine Replacement Therapy (NRT) n=593 participants at risk 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
Surgical and medical procedures Surgical and medical procedures	3.1% 20/652 • Number of events 22 • Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls. Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.	1.5% 9/593 • Number of events 9 • Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls. Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.

Other adverse events

Measure	Standard Care n=652 participants at risk Ask, Advise, Refer (physician brief advice)	Standard Care + Nicotine Replacement Therapy (NRT) n=593 participants at risk 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
General disorders Other	44.3% 289/652 • Number of events 625 • Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls. Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.	46.5% 276/593 • Number of events 596 • Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls. Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.

Additional Information

Amy Boatright, Program Coordinator

Medical University of South Carolina

Phone: 843-876-2440

Email: boatrigh@musc.edu

Results disclosure agreements

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