Trial Outcomes & Findings for Combination Nicotine Replacement for Alcoholic Smokers (NCT NCT00064844)

NCT ID: NCT00064844

Last Updated: 2021-08-13

Results Overview

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 96 participants
• Primary outcome timeframe: 6 months after smoking quit date
• Results posted on: 2021-08-13

Participant Flow

96 men and women were randomized to treatment at the Newington and West Haven campuses of the Veterans Affairs (VA) Connecticut Healthcare System.

Participant milestones

Measure	Nicotine Patch Plus Active Gum	Nicotine Patch Plus Placebo Gum
Overall Study STARTED	45	51
Overall Study 2 Week Follow-up	45	51
Overall Study 3 Month Follow-up	40	47
Overall Study 6 Month Follow-up	39	40
Overall Study 12 Month Follow-up	37	32
Overall Study COMPLETED	37	32
Overall Study NOT COMPLETED	8	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Nicotine Replacement for Alcoholic Smokers

Baseline characteristics by cohort

Measure	Nicotine Patch Plus Active Gum n=45 Participants	Nicotine Patch Plus Placebo Gum n=51 Participants	Total n=96 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	44.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	51 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after smoking quit date

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Outcome measures

Measure	Nicotine Patch Plus Active Gum n=39 Participants	Nicotine Patch Plus Placebo Gum n=40 Participants
6 Month Smoking Abstinence	20 percentage of participants abstinent	12 percentage of participants abstinent

PRIMARY outcome

Timeframe: 12 months after smoking quit date

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Outcome measures

Measure	Nicotine Patch Plus Active Gum n=37 Participants	Nicotine Patch Plus Placebo Gum n=32 Participants
12 Month Smoking Abstinence	13 percentage of participants abstinent	0 percentage of participants abstinent

Adverse Events

Nicotine Patch Plus Active Gum

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nicotine Patch Plus Placebo Gum

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nicotine Patch Plus Active Gum n=45 participants at risk	Nicotine Patch Plus Placebo Gum n=51 participants at risk
General disorders bleeding gums	2.2% 1/45 • Number of events 1	13.7% 7/51 • Number of events 7
General disorders jaw ache	0.00% 0/45	9.8% 5/51 • Number of events 5

Additional Information

Ned Cooney, PhD

Yale University School of Medicine

Phone: 860-594-6339

Email: ned.cooney@yale.edu

Results disclosure agreements

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