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Effect of Galantamine on Smoking Abstinence

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ClinicalTrials.gov Identifier: NCT01548638
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : July 2, 2014
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Nicotine Addiction
Intervention: Drug: Galantamine ER

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Galantamine ER
STARTED   13 
COMPLETED   9 
NOT COMPLETED   4 
Protocol Violation                3 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Galantamine ER 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (7.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  38.5% 
Male      8  61.5% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   Number of Days of Abstinence During a 7-day Quit Attempt   [ Time Frame: Days 36-43; following a 5-week dose run-up ]

2.  Secondary:   Cognitive Performance: Working Memory Reaction Time   [ Time Frame: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43 ]

3.  Secondary:   Cognitive Performance: Working Memory Accuracy   [ Time Frame: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43 ]

4.  Secondary:   Subjective Symptoms (Smoking Urges)   [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ]

5.  Secondary:   Side Effects of Galantamine   [ Time Frame: Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session ]

6.  Secondary:   Subjective Symptoms (Negative Affect)   [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ]

7.  Secondary:   Subjective Symptoms (Nicotine Withdrawal)   [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rebecca Ashare
Organization: University of Pennsylvania Perelman School of Medicine
phone: 2157465789
e-mail: rlashare@mail.med.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01548638     History of Changes
Other Study ID Numbers: 814947
First Submitted: March 5, 2012
First Posted: March 8, 2012
Results First Submitted: October 30, 2013
Results First Posted: July 2, 2014
Last Update Posted: December 26, 2017