Trial Outcomes & Findings for Effect of Galantamine on Smoking Abstinence (NCT NCT01548638)
NCT ID: NCT01548638
Last Updated: 2017-12-26
Results Overview
Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.
COMPLETED
PHASE2
13 participants
Days 36-43; following a 5-week dose run-up
2017-12-26
Participant Flow
Overall, since recruitment was initiated in March, 2012, 49 (45%) of the 109 completed phone screens resulted in a subject eligible for Intake. Of these subjects, 41 (84%) scheduled an in-person screening visit at our center.
Of the 29 subjects (73%) who attended the initial eligibility visit, 5 withdrew post enrollment (at visit), 11 were ineligible, and 13 subjects were deemed eligible.
Participant milestones
| Measure |
Galantamine ER
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Galantamine ER
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effect of Galantamine on Smoking Abstinence
Baseline characteristics by cohort
| Measure |
Galantamine ER
n=13 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
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Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=93 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Days 36-43; following a 5-week dose run-upParticipants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
|
Number of Days of Abstinence During a 7-day Quit Attempt
|
5 days
Interval 0.0 to 7.0
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SECONDARY outcome
Timeframe: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back. Median reaction time to correct responses is described below. Typical responses range from 250 ms to 1500 ms.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
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Cognitive Performance: Working Memory Reaction Time
Working Memory Reaction Time Baseline
|
575 ms
Standard Deviation 122
|
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Cognitive Performance: Working Memory Reaction Time
Working Memory Reaction Time Day 35
|
641 ms
Standard Deviation 141
|
|
Cognitive Performance: Working Memory Reaction Time
Working Memory Reaction Time Day 43
|
709 ms
Standard Deviation 158
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SECONDARY outcome
Timeframe: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back. Number of correct responses (true positives) is described below. The maximum number of correct responses is 60.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
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Cognitive Performance: Working Memory Accuracy
Working Memory Accuracy Baseline
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46 correct responses
Standard Deviation 6.6
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Cognitive Performance: Working Memory Accuracy
Working Memory Day 43
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46.7 correct responses
Standard Deviation 7.9
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Cognitive Performance: Working Memory Accuracy
Working Memory Day 35
|
47.4 correct responses
Standard Deviation 7.7
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SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 43; Baseline sessionDuring each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). This measure is an index of urges to smoke, or cigarette craving. The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). The range of possible scores on the QSU-B is 10-70, with higher values indicating increased urges to smoke. This range of scores represents a "total" score; there are no subscales.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
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Subjective Symptoms (Smoking Urges)
Baseline
|
30.3 units on a scale
Standard Deviation 13.9
|
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Subjective Symptoms (Smoking Urges)
Day 7
|
22.3 units on a scale
Standard Deviation 9.4
|
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Subjective Symptoms (Smoking Urges)
Day 39
|
19.5 units on a scale
Standard Deviation 12.4
|
|
Subjective Symptoms (Smoking Urges)
Day 43
|
17.5 units on a scale
Standard Deviation 8.9
|
|
Subjective Symptoms (Smoking Urges)
Day 14
|
17 units on a scale
Standard Deviation 8.5
|
|
Subjective Symptoms (Smoking Urges)
Day 21
|
20.7 units on a scale
Standard Deviation 12.6
|
|
Subjective Symptoms (Smoking Urges)
Day 28
|
21.5 units on a scale
Standard Deviation 11.4
|
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Subjective Symptoms (Smoking Urges)
Day 35
|
34.1 units on a scale
Standard Deviation 16.8
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Subjective Symptoms (Smoking Urges)
Day 37
|
21.3 units on a scale
Standard Deviation 11.0
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SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline sessionSide effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included. Items were measured on a scale from 0 (None) to 3 (Severe). The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe).
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
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Side Effects of Galantamine
Baseline
|
0.086 units on a scale
Standard Deviation 0.11
|
|
Side Effects of Galantamine
Day 7
|
0.13 units on a scale
Standard Deviation 0.21
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|
Side Effects of Galantamine
Day 14
|
0.068 units on a scale
Standard Deviation 0.12
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|
Side Effects of Galantamine
Day 21
|
0.073 units on a scale
Standard Deviation 0.093
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Side Effects of Galantamine
Day 35
|
0.11 units on a scale
Standard Deviation 0.19
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Side Effects of Galantamine
Day 37
|
0.042 units on a scale
Standard Deviation 0.059
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|
Side Effects of Galantamine
Day 43
|
0.06 units on a scale
Standard Deviation 0.042
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|
Side Effects of Galantamine
Day 28
|
0.057 units on a scale
Standard Deviation 0.098
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Side Effects of Galantamine
Day 39
|
0.07 units on a scale
Standard Deviation 0.075
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SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 43; Baseline sessionSubjects were asked to complete the Positive and Negative Affect Scale (PANAS) to assess symptoms of negative affect (the positive affect scale was not administered). This 10-item scale assesses was assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). The range of possible total scores on the PANAS negative affect scale is 10-50, with higher values indicating an increased nicotine withdrawal. This range of scores represent a "total" score; there are no subscales within the negative affect scale of the PANAS.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
|
Subjective Symptoms (Negative Affect)
Baseline
|
11.4 units on a scale
Standard Deviation 1.2
|
|
Subjective Symptoms (Negative Affect)
Day 7
|
10.1 units on a scale
Standard Deviation .35
|
|
Subjective Symptoms (Negative Affect)
Day 14
|
10.6 units on a scale
Standard Deviation .74
|
|
Subjective Symptoms (Negative Affect)
Day 21
|
10.0 units on a scale
Standard Deviation 0.48
|
|
Subjective Symptoms (Negative Affect)
Day 28
|
14.8 units on a scale
Standard Deviation 8.3
|
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Subjective Symptoms (Negative Affect)
Day 35
|
11.1 units on a scale
Standard Deviation 1.5
|
|
Subjective Symptoms (Negative Affect)
Day 37
|
11.2 units on a scale
Standard Deviation 1.6
|
|
Subjective Symptoms (Negative Affect)
Day 39
|
12.5 units on a scale
Standard Deviation 4.4
|
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Subjective Symptoms (Negative Affect)
Day 43
|
11.3 units on a scale
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, 35, and 43; Baseline sessionSubjects were asked to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The subjective symptoms listed above were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a "total" score; there are no subscales.
Outcome measures
| Measure |
Galantamine ER
n=9 Participants
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
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|---|---|
|
Subjective Symptoms (Nicotine Withdrawal)
Baseline
|
4.3 units on a scale
Standard Deviation 1.9
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 7
|
4.3 units on a scale
Standard Deviation 2.3
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 43
|
2.4 units on a scale
Standard Deviation 2.1
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 14
|
3 units on a scale
Standard Deviation 2.4
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 21
|
3.9 units on a scale
Standard Deviation 2.8
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 28
|
3.2 units on a scale
Standard Deviation 2.6
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 35
|
7 units on a scale
Standard Deviation 8.1
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 37
|
4 units on a scale
Standard Deviation 3.4
|
|
Subjective Symptoms (Nicotine Withdrawal)
Day 39
|
4.9 units on a scale
Standard Deviation 4.1
|
Adverse Events
Galantamine ER
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Ashare
University of Pennsylvania Perelman School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place