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Effect of Galantamine on Short-term Abstinence (GAL-K)

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ClinicalTrials.gov Identifier: NCT01669538
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
National Center for Research Resources (NCRR)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Interventions Drug: Galantamine
Drug: Placebo
Enrollment 98
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 40 42
Completed 28 33
Not Completed 12 9
Arm/Group Title Galantamine Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 40 42 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 82 participants
42.9  (11.3) 42.8  (10.9) 42.8  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
Female
18
  45.0%
13
  31.0%
31
  37.8%
Male
22
  55.0%
29
  69.0%
51
  62.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
Hispanic or Latino
2
   5.0%
2
   4.8%
4
   4.9%
Not Hispanic or Latino
38
  95.0%
40
  95.2%
78
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
24
  60.0%
26
  61.9%
50
  61.0%
White
13
  32.5%
9
  21.4%
22
  26.8%
More than one race
2
   5.0%
5
  11.9%
7
   8.5%
Unknown or Not Reported
1
   2.5%
2
   4.8%
3
   3.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants 42 participants 82 participants
40
 100.0%
42
 100.0%
82
 100.0%
Nicotine Dependence   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 42 participants 82 participants
5.1  (1.5) 5.4  (1.8) 5.2  (1.7)
[1]
Measure Description: Self-report measure of nicotine dependence on a scale from 0 to 10 with 0 being not at all dependent and 10 being highly dependent.
Cigarettes per day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes
Number Analyzed 40 participants 42 participants 82 participants
15.2  (4.7) 15.5  (6.9) 15.4  (5.9)
1.Primary Outcome
Title Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt.
Hide Description Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.
Time Frame Days 17-23
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the study in each arm
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 33
Mean (Standard Deviation)
Unit of Measure: days
3.6  (2.3) 3.7  (2.3)
2.Secondary Outcome
Title Cognitive Performance
Hide Description 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.
Time Frame Baseline (Day 0), Day 14 (day before start of 24-hour abstinence period), Day 16 (after 24-hour abstinence period ends)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the study in each arm
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 33
Mean (Standard Deviation)
Unit of Measure: number of correct responses
Working memory (Baseline) 47.3  (5.0) 46.6  (5.6)
Working memory (Day 14) 49.0  (4.6) 48.4  (5.1)
Working memory (Day 16) 49.3  (7.0) 47.1  (6.9)
Attention (Baseline) 111.3  (8.9) 103.4  (20.4)
Attention (Day 14) 113.9  (8.3) 110.5  (11.3)
Attention (Day 16) 115.2  (6.4) 111.0  (11.6)
3.Secondary Outcome
Title Subjective Symptoms
Hide Description

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).

Time Frame Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the study in each arm
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Smoking urges (baseline) 29.4  (13) 30.2  (14.4)
Smoking urges (day 7) 21.6  (9.8) 25.9  (15.4)
Smoking urges (day 14) 21.1  (13.2) 24.1  (12.5)
Smoking urges (day 16) 33  (15.6) 36  (17.3)
Smoking urges (day 17) 21.7  (9.9) 29.7  (17.8)
Smoking urges (day 19) 20.7  (11.8) 25.2  (14.1)
Smoking urges (day 21) 19.8  (9.6) 22.2  (12.5)
Smoking urges (day 23) 18.8  (8.6) 23.2  (14.2)
Negative Mood (baseline) 12.2  (2.9) 12.7  (4.5)
Negative Mood (day 7) 11.2  (2.6) 12.0  (3.7)
Negative Mood (day 14) 11.8  (3.5) 11.9  (3.6)
Negative Mood (day 16) 13.7  (5.7) 13.9  (4.4)
Negative Mood (day 17) 11.6  (3.5) 11.7  (2.6)
Negative Mood (day 19) 11.6  (2.9) 12.0  (2.9)
Negative Mood (day 21) 12.0  (3.6) 11.8  (2.3)
Negative Mood (day 23) 11.1  (2.5) 12.0  (3.6)
Withdrawal (baseline) 5  (2.8) 5.6  (4.2)
Withdrawal (day 7) 4.6  (2.3) 5.4  (4.5)
Withdrawal (day 14) 5.1  (3.8) 3.9  (4.2)
Withdrawal (day 16) 7.6  (6.2) 7.7  (5.7)
Withdrawal (day 17) 4.6  (4.4) 4.6  (4.7)
Withdrawal (day 19) 5.2  (4) 4.6  (4.5)
Withdrawal (day 21) 4.7  (3.5) 4.8  (3.9)
Withdrawal (day 23) 3.2  (3.5) 4.1  (5.0)
4.Secondary Outcome
Title Common Side Effects of Galantamine Check List
Hide Description

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).

Time Frame Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the study in each arm
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline .03  (.06) .04  (.07)
Day 7 .09  (.09) .07  (.08)
Day 14 .1  (.15) .06  (.11)
Day 16 .1  (.12) .08  (.1)
Day 17 .08  (.12) .05  (.08)
Day 19 .07  (.09) .05  (.09)
Day 21 .06  (.08) .05  (.08)
Day 23 .05  (.06) .05  (.08)
Time Frame 23 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Galantamine Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Galantamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Galantamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Galantamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/40 (10.00%)      3/42 (7.14%)    
General disorders     
Difficulty sleeping   4/40 (10.00%)  10 3/42 (7.14%)  6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rebecca Ashare
Organization: University of Pennsylvania
Phone: 2157465789
EMail: rlashare@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01669538    
Obsolete Identifiers: NCT01845961
Other Study ID Numbers: 815789
UPCC15912 ( Other Identifier: Abramson Cancer Center of the University of Pennsylvania )
K23DA035295 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2012
First Posted: August 21, 2012
Results First Submitted: December 11, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019