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Trial Outcomes & Findings for Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia (NCT NCT01010477)

NCT ID: NCT01010477

Last Updated: 2014-09-08

Results Overview

Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-09-08

Participant Flow

141 subjects screened. Of these 66 were consented. Eleven were later found to be ineligible and were dropped prior to randomization. Fifty five subjects were randomized to active or placebo NNS. Three subjects were found to be not eligible after randomization leaving 52 for analysis.

Participant milestones

Participant milestones
Measure
NNS Active
Receives active nicotine containing Nasal spray
Placebo
Receives placebo (piperine)nasal spray
Overall Study
STARTED
27
25
Overall Study
COMPLETED
21
22
Overall Study
NOT COMPLETED
6
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NNS Active
n=27 Participants
Receives nicotine (active) nasal spray
Placebo NS
n=25 Participants
Receives placebo (piperine containing) nasal spray
Total
n=52 Participants
Total of all reporting groups
Age, Continuous
42.4 years
STANDARD_DEVIATION 12.8 • n=99 Participants
48.4 years
STANDARD_DEVIATION 10.5 • n=107 Participants
45.3 years
STANDARD_DEVIATION 12.0 • n=206 Participants
Sex: Female, Male
Female
9 Participants
n=99 Participants
11 Participants
n=107 Participants
20 Participants
n=206 Participants
Sex: Female, Male
Male
18 Participants
n=99 Participants
14 Participants
n=107 Participants
32 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=99 Participants
13 Participants
n=107 Participants
27 Participants
n=206 Participants
Race (NIH/OMB)
White
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 4 weeks

Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.

Outcome measures

Outcome measures
Measure
NNS Active
n=27 Participants
Receives nicotine (active ) nasal spray
Placebo
n=25 Participants
Receives placebo (piperine)nasal spray
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
3 participants
1 participants

Adverse Events

NNS Active

Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
NNS Active
n=27 participants at risk
Receives nicotine (active) nasal spray
Placebo
n=25 participants at risk
Receives placebo (piperine)nasal spray
Respiratory, thoracic and mediastinal disorders
Sneezing
66.7%
18/27 • adverse event data were collected for 1 year
24.0%
6/25 • adverse event data were collected for 1 year
Ear and labyrinth disorders
throat irritation
44.4%
12/27 • adverse event data were collected for 1 year
4.0%
1/25 • adverse event data were collected for 1 year

Additional Information

Jill Williams, MD, Principal Investigator

Rutgers-Robert Wood Johnson Medical School

Phone: 7322354341

Results disclosure agreements

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