Trial Outcomes & Findings for A Study to Help People Quit Smoking. (NCT NCT01880099)
NCT ID: NCT01880099
Last Updated: 2020-03-23
Results Overview
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Data was acquired during a single test session during week 3 of drug intervention.
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (sugar Pill) will be given daily for 7 weeks.
placebo: placebo compared to 8mg of galatamine
|
Galantamine 8mg
Galantamine extended release (8mg) will be given daily for 7 weeks.
Galantamine 8mg: 8mg of galatamine compared to placebo
|
Galantamine 16mg
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Galantamine 16mg: 16mg of galatamine compared to placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
21
|
22
|
|
Overall Study
COMPLETED
|
9
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Help People Quit Smoking.
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Placebo (sugar Pill) will be given daily for 7 weeks.
placebo: placebo compared to 8mg of galatamine
|
Galantamine 8mg
n=21 Participants
Galantamine extended release (8mg) will be given daily for 7 weeks.
Galantamine 8mg: 8mg of galatamine compared to placebo
|
Galantamine 16mg
n=22 Participants
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Galantamine 16mg: 16mg of galatamine compared to placebo
|
Total
n=60 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
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 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
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Data was acquired during a single test session during week 3 of drug intervention.Population: The number of participants analyzed per arm for this outcome is different than participant flow data because not every participant completed the smoking choice session.
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo (sugar Pill) will be given daily for 7 weeks.
placebo: placebo compared to 8mg of galatamine
|
Galantamine 8mg
n=15 Participants
Galantamine extended release (8mg) will be given daily for 7 weeks.
Galantamine 8mg: 8mg of galatamine compared to placebo
|
Galantamine 16mg
n=20 Participants
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Galantamine 16mg: 16mg of galatamine compared to placebo
|
|---|---|---|---|
|
Smoking Choice Procedure
|
3.00 # of choices to smoke (out of 10)
Standard Deviation 3.08
|
1.00 # of choices to smoke (out of 10)
Standard Deviation 1.00
|
0.85 # of choices to smoke (out of 10)
Standard Deviation 1.35
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Galantamine 8mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Galantamine 16mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Placebo (sugar Pill) will be given daily for 7 weeks.
placebo: placebo compared to 8mg of galatamine
|
Galantamine 8mg
n=21 participants at risk
Galantamine extended release (8mg) will be given daily for 7 weeks.
Galantamine 8mg: 8mg of galatamine compared to placebo
|
Galantamine 16mg
n=22 participants at risk
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Galantamine 16mg: 16mg of galatamine compared to placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Stomach pain
|
17.6%
3/17 • Number of events 3 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
18.2%
4/22 • Number of events 4 • 7 weeks
|
|
Gastrointestinal disorders
Upset stomach
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
Gastrointestinal disorders
Vomitting
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
9.5%
2/21 • Number of events 2 • 7 weeks
|
0.00%
0/22 • 7 weeks
|
|
General disorders
Constipation
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
9.5%
2/21 • Number of events 2 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
General disorders
Loss of Appetite
|
23.5%
4/17 • Number of events 4 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
9.5%
2/21 • Number of events 2 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
Psychiatric disorders
Nervousness
|
23.5%
4/17 • Number of events 4 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
Psychiatric disorders
Restlessness
|
17.6%
3/17 • Number of events 3 • 7 weeks
|
28.6%
6/21 • Number of events 6 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
General disorders
Difficulty sleeping
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
36.4%
8/22 • Number of events 8 • 7 weeks
|
|
General disorders
Drowsy
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
28.6%
6/21 • Number of events 6 • 7 weeks
|
18.2%
4/22 • Number of events 4 • 7 weeks
|
|
General disorders
Fatigue
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
General disorders
Anger
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
Psychiatric disorders
Depressed mood
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
18.2%
4/22 • Number of events 4 • 7 weeks
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
General disorders
Teary/dry eyes
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
General disorders
Runny nose
|
23.5%
4/17 • Number of events 4 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
General disorders
Back/ muscle pain
|
23.5%
4/17 • Number of events 4 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
General disorders
Sweating
|
17.6%
3/17 • Number of events 3 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
General disorders
Excessive hunger
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
27.3%
6/22 • Number of events 6 • 7 weeks
|
|
General disorders
dry mouth
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
27.3%
6/22 • Number of events 6 • 7 weeks
|
|
General disorders
change in the ability to taste food
|
0.00%
0/17 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
Gastrointestinal disorders
heartburn
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
4.8%
1/21 • Number of events 1 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
Nervous system disorders
headache
|
17.6%
3/17 • Number of events 3 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
Eye disorders
blurred vision
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
4.8%
1/21 • Number of events 1 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
Gastrointestinal disorders
Gas
|
17.6%
3/17 • Number of events 3 • 7 weeks
|
23.8%
5/21 • Number of events 5 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
|
General disorders
lighted headed
|
0.00%
0/17 • 7 weeks
|
9.5%
2/21 • Number of events 2 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
Gastrointestinal disorders
weight loss
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
0.00%
0/21 • 7 weeks
|
18.2%
4/22 • Number of events 4 • 7 weeks
|
|
Gastrointestinal disorders
Sudden hunger
|
0.00%
0/17 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
22.7%
5/22 • Number of events 5 • 7 weeks
|
|
General disorders
concentration
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
9.5%
2/21 • Number of events 2 • 7 weeks
|
4.5%
1/22 • Number of events 1 • 7 weeks
|
|
Gastrointestinal disorders
nausea
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
4.8%
1/21 • Number of events 1 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1 • 7 weeks
|
4.8%
1/21 • Number of events 1 • 7 weeks
|
9.1%
2/22 • Number of events 2 • 7 weeks
|
|
Psychiatric disorders
Aggresive behavior
|
0.00%
0/17 • 7 weeks
|
14.3%
3/21 • Number of events 3 • 7 weeks
|
4.5%
1/22 • Number of events 1 • 7 weeks
|
|
General disorders
mood swings
|
11.8%
2/17 • Number of events 2 • 7 weeks
|
19.0%
4/21 • Number of events 4 • 7 weeks
|
13.6%
3/22 • Number of events 3 • 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place