Trial Outcomes & Findings for A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers (NCT NCT00706979)

NCT ID: NCT00706979

Last Updated: 2011-12-09

Results Overview

The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 849 participants
• Primary outcome timeframe: From study enrollment through six month follow-up
• Results posted on: 2011-12-09

Participant Flow

Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment.

Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment.

Participant milestones

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
Overall Study STARTED	426	423
Overall Study COMPLETED	426	423
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

Baseline characteristics by cohort

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 Participants This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 Participants This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).	Total n=849 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	382 Participants n=5 Participants	389 Participants n=7 Participants	771 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	34 Participants n=7 Participants	78 Participants n=5 Participants
Age Continuous	50.5 years STANDARD_DEVIATION 11.8 • n=5 Participants	50.7 years STANDARD_DEVIATION 11.4 • n=7 Participants	50.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	266 Participants n=5 Participants	279 Participants n=7 Participants	545 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants	144 Participants n=7 Participants	304 Participants n=5 Participants
Region of Enrollment United States	426 participants n=5 Participants	423 participants n=7 Participants	849 participants n=5 Participants

PRIMARY outcome

Timeframe: From study enrollment through six month follow-up

Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.

The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.

Outcome measures

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 Participants This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 Participants This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	208 participants	168 participants

PRIMARY outcome

Timeframe: From study enrollment through six month follow-up

Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.

Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.

Outcome measures

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 Participants This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 Participants This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	185 participants	143 participants

SECONDARY outcome

Timeframe: At any point during the study

Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.

Outcome measures

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 Participants This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 Participants This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days	82 participants	63 participants

SECONDARY outcome

Timeframe: At 6-month follow-up

Population: All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.

Outcome measures

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 Participants This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 Participants This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days	68 participants	57 participants

Adverse Events

Practice Quit Attempt Plus Nicotine Replacement Therapy

Serious events: 0 serious events

Other events: 179 other events

Deaths: 0 deaths

Practice Quit Attempt Only

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 participants at risk This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 participants at risk This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
Renal and urinary disorders Death	0.00% 0/426 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.	0.24% 1/423 • Number of events 1 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.

Other adverse events

Measure	Practice Quit Attempt Plus Nicotine Replacement Therapy n=426 participants at risk This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.	Practice Quit Attempt Only n=423 participants at risk This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
Gastrointestinal disorders Nausea/stomach upset (dyspepsia)	18.8% 80/426 • Number of events 80 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.	— 0/0 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.
General disorders Throat irritation	14.1% 60/426 • Number of events 60 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.	— 0/0 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.
General disorders Hiccups	10.6% 45/426 • Number of events 45 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.	— 0/0 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.
Gastrointestinal disorders Heartburn	5.4% 23/426 • Number of events 23 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.	— 0/0 • Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.

Additional Information

Matthew J. Carpenter

Medical University of South Carolina'

Phone: 843-792-3974

Email: carpente@musc.edu

Results disclosure agreements

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