Trial Outcomes & Findings for Nicotine Delivery Systems: Research & Treatment (NCT NCT00108342)
NCT ID: NCT00108342
Last Updated: 2014-06-04
Results Overview
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
TERMINATED
NA
25 participants
At testing, at follow-up
2014-06-04
Participant Flow
25 enrollees gave their signed consent and were then screened for participation; a total of 17 participated in testing.
Participant milestones
| Measure |
NRT Sampling
Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)
|
NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Delivery Systems: Research & Treatment
Baseline characteristics by cohort
| Measure |
NRT Sampling
n=8 Participants
Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)
|
NRT Computer Learning
n=9 Participants
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At testing, at follow-upPopulation: The study was terminated and the data were not analyzed due to the small sample size.
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
Outcome measures
Outcome data not reported
Adverse Events
NRT Sampling
NRT Computer Learning
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NRT Sampling
n=8 participants at risk
Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)
|
NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
|
|---|---|---|
|
Gastrointestinal disorders
Nausea or Light-Headedness
|
37.5%
3/8 • Number of events 3
Assessment of adverse events was carried out by the PI, a Study Physician, and a Research Assistant. In this study, a non-serious adverse event was one that involved expected side effects of the medications. These were monitored for the NRT Sampling Arm during testing. Side effects were not assessed for the Computer Learning intervention.
|
—
0/0
Assessment of adverse events was carried out by the PI, a Study Physician, and a Research Assistant. In this study, a non-serious adverse event was one that involved expected side effects of the medications. These were monitored for the NRT Sampling Arm during testing. Side effects were not assessed for the Computer Learning intervention.
|
Additional Information
Nina G. Schneider, Ph.D., Principle Investigator
Department of Veterans Affairs - VAGLA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place