Trial Outcomes & Findings for Effect of Galantamine on Short-term Abstinence (NCT NCT01669538)
NCT ID: NCT01669538
Last Updated: 2019-02-15
Results Overview
Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Days 17-23
Results posted on
2019-02-15
Participant Flow
Of the 98 subjects who enrolled in the study, 16 were deemed ineligible to participate and therefore not assigned to a treatment arm (i.e., did not Start the study). Thus, 82 subjects Started the study.
Participant milestones
| Measure |
Galantamine
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
Placebo
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Galantamine on Short-term Abstinence
Baseline characteristics by cohort
| Measure |
Galantamine
n=40 Participants
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
Placebo
n=42 Participants
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Nicotine Dependence
|
5.1 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Cigarettes per day
|
15.2 cigarettes
STANDARD_DEVIATION 4.7 • n=5 Participants
|
15.5 cigarettes
STANDARD_DEVIATION 6.9 • n=7 Participants
|
15.4 cigarettes
STANDARD_DEVIATION 5.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Days 17-23Population: Number of subjects who completed the study in each arm
Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
Galantamine
n=28 Participants
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
|---|---|---|
|
Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt.
|
3.7 days
Standard Deviation 2.3
|
3.6 days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 14 (day before start of 24-hour abstinence period), Day 16 (after 24-hour abstinence period ends)Population: Number of subjects who completed the study in each arm
Participants will complete neurocognitive tests designed to test working memory and attention. These tests are similar to computer games, in that participants will push a button in response to the pictures they see.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
Galantamine
n=28 Participants
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
|---|---|---|
|
Cognitive Performance
Attention (Day 16)
|
111.0 number of correct responses
Standard Deviation 11.6
|
115.2 number of correct responses
Standard Deviation 6.4
|
|
Cognitive Performance
Working memory (Baseline)
|
46.6 number of correct responses
Standard Deviation 5.6
|
47.3 number of correct responses
Standard Deviation 5.0
|
|
Cognitive Performance
Working memory (Day 14)
|
48.4 number of correct responses
Standard Deviation 5.1
|
49.0 number of correct responses
Standard Deviation 4.6
|
|
Cognitive Performance
Working memory (Day 16)
|
47.1 number of correct responses
Standard Deviation 6.9
|
49.3 number of correct responses
Standard Deviation 7.0
|
|
Cognitive Performance
Attention (Baseline)
|
103.4 number of correct responses
Standard Deviation 20.4
|
111.3 number of correct responses
Standard Deviation 8.9
|
|
Cognitive Performance
Attention (Day 14)
|
110.5 number of correct responses
Standard Deviation 11.3
|
113.9 number of correct responses
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23Population: Number of subjects who completed the study in each arm
Smoking urges \[Questionnaire of Smoking Urges-Brief; QSU-B; 10-items rated on a 7-point scale (1=strongly disagree, 7=strongly agree) and summed for total score (range: 10-70). Higher scores=greater urge to smoke.\] Negative mood \[Negative Affect scale (10 items) from the Positive and Negative Affect Schedule; PANAS; 20-item Likert-format measure; The subscale was summed to create a summary score (range: 10-50); Lower negative affect indicates better outcomes.\] Nicotine withdrawal \[Minnesota Nicotine Withdrawal Scale-Revised; MNWS-R; 15 symptoms are rated on intensity with the following scale: 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. The first 9 items are summed for total score (range: 0-36); higher scores=more severe withdrawal.\]. Measures assessed at the following visits: Baseline; Day 7 (monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (7-day quit attempt).
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
Galantamine
n=28 Participants
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
|---|---|---|
|
Subjective Symptoms
Smoking urges (baseline)
|
30.2 units on a scale
Standard Deviation 14.4
|
29.4 units on a scale
Standard Deviation 13
|
|
Subjective Symptoms
Smoking urges (day 7)
|
25.9 units on a scale
Standard Deviation 15.4
|
21.6 units on a scale
Standard Deviation 9.8
|
|
Subjective Symptoms
Smoking urges (day 14)
|
24.1 units on a scale
Standard Deviation 12.5
|
21.1 units on a scale
Standard Deviation 13.2
|
|
Subjective Symptoms
Smoking urges (day 16)
|
36 units on a scale
Standard Deviation 17.3
|
33 units on a scale
Standard Deviation 15.6
|
|
Subjective Symptoms
Smoking urges (day 17)
|
29.7 units on a scale
Standard Deviation 17.8
|
21.7 units on a scale
Standard Deviation 9.9
|
|
Subjective Symptoms
Smoking urges (day 19)
|
25.2 units on a scale
Standard Deviation 14.1
|
20.7 units on a scale
Standard Deviation 11.8
|
|
Subjective Symptoms
Smoking urges (day 21)
|
22.2 units on a scale
Standard Deviation 12.5
|
19.8 units on a scale
Standard Deviation 9.6
|
|
Subjective Symptoms
Smoking urges (day 23)
|
23.2 units on a scale
Standard Deviation 14.2
|
18.8 units on a scale
Standard Deviation 8.6
|
|
Subjective Symptoms
Negative Mood (baseline)
|
12.7 units on a scale
Standard Deviation 4.5
|
12.2 units on a scale
Standard Deviation 2.9
|
|
Subjective Symptoms
Negative Mood (day 7)
|
12.0 units on a scale
Standard Deviation 3.7
|
11.2 units on a scale
Standard Deviation 2.6
|
|
Subjective Symptoms
Negative Mood (day 14)
|
11.9 units on a scale
Standard Deviation 3.6
|
11.8 units on a scale
Standard Deviation 3.5
|
|
Subjective Symptoms
Negative Mood (day 16)
|
13.9 units on a scale
Standard Deviation 4.4
|
13.7 units on a scale
Standard Deviation 5.7
|
|
Subjective Symptoms
Negative Mood (day 17)
|
11.7 units on a scale
Standard Deviation 2.6
|
11.6 units on a scale
Standard Deviation 3.5
|
|
Subjective Symptoms
Negative Mood (day 19)
|
12.0 units on a scale
Standard Deviation 2.9
|
11.6 units on a scale
Standard Deviation 2.9
|
|
Subjective Symptoms
Negative Mood (day 21)
|
11.8 units on a scale
Standard Deviation 2.3
|
12.0 units on a scale
Standard Deviation 3.6
|
|
Subjective Symptoms
Negative Mood (day 23)
|
12.0 units on a scale
Standard Deviation 3.6
|
11.1 units on a scale
Standard Deviation 2.5
|
|
Subjective Symptoms
Withdrawal (baseline)
|
5.6 units on a scale
Standard Deviation 4.2
|
5 units on a scale
Standard Deviation 2.8
|
|
Subjective Symptoms
Withdrawal (day 7)
|
5.4 units on a scale
Standard Deviation 4.5
|
4.6 units on a scale
Standard Deviation 2.3
|
|
Subjective Symptoms
Withdrawal (day 14)
|
3.9 units on a scale
Standard Deviation 4.2
|
5.1 units on a scale
Standard Deviation 3.8
|
|
Subjective Symptoms
Withdrawal (day 16)
|
7.7 units on a scale
Standard Deviation 5.7
|
7.6 units on a scale
Standard Deviation 6.2
|
|
Subjective Symptoms
Withdrawal (day 17)
|
4.6 units on a scale
Standard Deviation 4.7
|
4.6 units on a scale
Standard Deviation 4.4
|
|
Subjective Symptoms
Withdrawal (day 19)
|
4.6 units on a scale
Standard Deviation 4.5
|
5.2 units on a scale
Standard Deviation 4
|
|
Subjective Symptoms
Withdrawal (day 21)
|
4.8 units on a scale
Standard Deviation 3.9
|
4.7 units on a scale
Standard Deviation 3.5
|
|
Subjective Symptoms
Withdrawal (day 23)
|
4.1 units on a scale
Standard Deviation 5.0
|
3.2 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23Population: Number of subjects who completed the study in each arm
Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects rated the severity of 37 common side effects of galantamine on the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The average of all items was used to create a summary side effect score (range for total summary score 0-3). Higher scores indicate greater severity of side effects. Side effects of galantamine were assessed at the following in-person sessions: Baseline session; Day 7 (brief monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (during the 7-day quit attempt).
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
Galantamine
n=28 Participants
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
|---|---|---|
|
Common Side Effects of Galantamine Check List
Baseline
|
.04 units on a scale
Standard Deviation .07
|
.03 units on a scale
Standard Deviation .06
|
|
Common Side Effects of Galantamine Check List
Day 7
|
.07 units on a scale
Standard Deviation .08
|
.09 units on a scale
Standard Deviation .09
|
|
Common Side Effects of Galantamine Check List
Day 14
|
.06 units on a scale
Standard Deviation .11
|
.1 units on a scale
Standard Deviation .15
|
|
Common Side Effects of Galantamine Check List
Day 16
|
.08 units on a scale
Standard Deviation .1
|
.1 units on a scale
Standard Deviation .12
|
|
Common Side Effects of Galantamine Check List
Day 17
|
.05 units on a scale
Standard Deviation .08
|
.08 units on a scale
Standard Deviation .12
|
|
Common Side Effects of Galantamine Check List
Day 19
|
.05 units on a scale
Standard Deviation .09
|
.07 units on a scale
Standard Deviation .09
|
|
Common Side Effects of Galantamine Check List
Day 21
|
.05 units on a scale
Standard Deviation .08
|
.06 units on a scale
Standard Deviation .08
|
|
Common Side Effects of Galantamine Check List
Day 23
|
.05 units on a scale
Standard Deviation .08
|
.05 units on a scale
Standard Deviation .06
|
Adverse Events
Galantamine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
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 |
Galantamine
n=40 participants at risk
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Galantamine
|
Placebo
n=42 participants at risk
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo
|
|---|---|---|
|
General disorders
Difficulty sleeping
|
10.0%
4/40 • Number of events 10 • 23 days
|
7.1%
3/42 • Number of events 6 • 23 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place