Trial Outcomes & Findings for Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia (NCT NCT00136760)
NCT ID: NCT00136760
Last Updated: 2015-10-07
Results Overview
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
3 weeks
Results posted on
2015-10-07
Participant Flow
Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.
Participants underwent telephone and in-person screening for eligibility criteria.
Participant milestones
| Measure |
CM + BUP
Contingent reinforcement plus bupropion
|
CM + PLA
Contingent reinforcement plus placebo
|
NR + BUP
Non-contingent reinforcement plus bupropion
|
NR + PLA
Non-contingent reinforcement plus placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
11
|
13
|
|
Overall Study
COMPLETED
|
12
|
16
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Baseline characteristics by cohort
| Measure |
CM + BUP
n=12 Participants
Contingent reinforcement plus bupropion
|
CM + PLA
n=16 Participants
Contingent reinforcement plus placebo
|
NR + BUP
n=11 Participants
Non-contingent reinforcement plus bupropion
|
NR + PLA
n=13 Participants
Non-contingent reinforcement plus placebo
|
Total
n=52 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
11 participants
n=5 Participants
|
13 participants
n=4 Participants
|
52 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 weeksUrinary Cotinine levels at Week 4 (average of last 3 study visits)
Outcome measures
| Measure |
CM + BUP
n=12 Participants
Contingent reinforcement plus bupropion
|
CM + PLA
n=16 Participants
Contingent reinforcement plus placebo
|
NR + BUP
n=11 Participants
Non-contingent reinforcement plus bupropion
|
NR + PLA
n=13 Participants
Non-contingent reinforcement plus placebo
|
|---|---|---|---|---|
|
Urinary Cotinine
|
755 ng/ml
Standard Deviation 533
|
1102 ng/ml
Standard Deviation 639
|
1534 ng/ml
Standard Deviation 489
|
1408 ng/ml
Standard Deviation 490
|
SECONDARY outcome
Timeframe: 3 weeksOutcome measures
| Measure |
CM + BUP
n=12 Participants
Contingent reinforcement plus bupropion
|
CM + PLA
n=16 Participants
Contingent reinforcement plus placebo
|
NR + BUP
n=11 Participants
Non-contingent reinforcement plus bupropion
|
NR + PLA
n=13 Participants
Non-contingent reinforcement plus placebo
|
|---|---|---|---|---|
|
Cigarettes Smoked Per Day
|
12.7 cigarettes per day
Standard Deviation 7.4
|
13.9 cigarettes per day
Standard Deviation 9.5
|
18.8 cigarettes per day
Standard Deviation 12.9
|
21.0 cigarettes per day
Standard Deviation 9.3
|
Adverse Events
CM + BUP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CM + PLA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NR + BUP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
NR + PLA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CM + BUP
n=12 participants at risk
Contingent reinforcement plus bupropion
|
CM + PLA
n=16 participants at risk
Contingent reinforcement plus placebo
|
NR + BUP
n=11 participants at risk
Non-contingent reinforcement plus bupropion
|
NR + PLA
n=13 participants at risk
Non-contingent reinforcement plus placebo
|
|---|---|---|---|---|
|
Psychiatric disorders
opiate detoxification
|
0.00%
0/12
|
0.00%
0/16
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
diarrhea, vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/16
|
9.1%
1/11 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
fall
|
8.3%
1/12 • Number of events 1
|
0.00%
0/16
|
0.00%
0/11
|
0.00%
0/13
|
|
Social circumstances
blackout
|
8.3%
1/12 • Number of events 1
|
0.00%
0/16
|
0.00%
0/11
|
0.00%
0/13
|
|
Psychiatric disorders
anxiety, restlessness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/16
|
0.00%
0/11
|
0.00%
0/13
|
|
Gastrointestinal disorders
bleeding ulcer
|
0.00%
0/12
|
0.00%
0/16
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
chest pain
|
0.00%
0/12
|
0.00%
0/16
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place