Trial Outcomes & Findings for Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment (NCT NCT02676375)
NCT ID: NCT02676375
Last Updated: 2019-07-30
Results Overview
Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
Measured week 0, 12, and 26
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Standard Monotherapy
Treatment as usual starting with one smoking cessation medication plus group therapy.
Monotherapy
|
Combination Extended Treatment
Extended treatment with multiple standard medications plus group therapy.
Combination Bupropion + NRTs
Extended Treatment
|
Combination Extended Treatment + Home Visits/Calls
Extended treatment with multiple standard medications plus group therapy plus home visits.
Combination Bupropion + NRTs
Extended Treatment
Home Visits \& Calls
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
13
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
Baseline characteristics by cohort
| Measure |
Standard Monotherapy
n=14 Participants
Treatment as usual starting with one smoking cessation medication plus group therapy.
Monotherapy
|
Combination Extended Treatment
n=14 Participants
Extended treatment with multiple standard medications plus group therapy.
Combination Bupropion + NRTs
Extended Treatment
|
Combination Extended Treatment + Home Visits/Calls
n=14 Participants
Extended treatment with multiple standard medications plus group therapy plus home visits.
Combination Bupropion + NRTs
Extended Treatment
Home Visits \& Calls
|
Total
n=42 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 8 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10 • n=7 Participants
|
56 years
STANDARD_DEVIATION 8 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured week 0, 12, and 26Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).
Outcome measures
| Measure |
Standard Monotherapy
n=13 Participants
Treatment as usual starting with one smoking cessation medication plus group therapy.
Monotherapy
|
Combination Extended Treatment
n=10 Participants
Extended treatment with multiple standard medications plus group therapy.
Combination Bupropion + NRTs
Extended Treatment
|
Combination Extended Treatment + Home Visits/Calls
n=11 Participants
Extended treatment with multiple standard medications plus group therapy plus home visits.
Combination Bupropion + NRTs
Extended Treatment
Home Visits \& Calls
|
|---|---|---|---|
|
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)
Week 26
|
10.7 ppm
Standard Deviation 7.6
|
5.0 ppm
Standard Deviation 3.3
|
5.0 ppm
Standard Deviation 4.4
|
|
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)
Week 0
|
11.5 ppm
Standard Deviation 5.1
|
12.3 ppm
Standard Deviation 9.9
|
12.0 ppm
Standard Deviation 4.8
|
|
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)
Week 12
|
7.8 ppm
Standard Deviation 7.9
|
5.6 ppm
Standard Deviation 4.5
|
5.9 ppm
Standard Deviation 4.5
|
Adverse Events
Standard Monotherapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Combination Extended Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination Extended Treatment + Home Visits/Calls
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Monotherapy
n=13 participants at risk
Treatment as usual starting with one smoking cessation medication plus group therapy.
Monotherapy
|
Combination Extended Treatment
n=10 participants at risk
Extended treatment with multiple standard medications plus group therapy.
Combination Bupropion + NRTs
Extended Treatment
|
Combination Extended Treatment + Home Visits/Calls
n=11 participants at risk
Extended treatment with multiple standard medications plus group therapy plus home visits.
Combination Bupropion + NRTs
Extended Treatment
Home Visits \& Calls
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
10.0%
1/10 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
9.1%
1/11 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
|
Psychiatric disorders
Vivid dreams
|
7.7%
1/13 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
20.0%
2/10 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
0.00%
0/11 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
|
Skin and subcutaneous tissue disorders
Rash (with the patch)
|
7.7%
1/13 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
0.00%
0/10 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
18.2%
2/11 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
0.00%
0/10 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
0.00%
0/11 • For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
|
Additional Information
Dr. Arthur Brody
Department of Psychiatry, University of California San Diego
Phone: 8585528585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place