Effect of Galantamine on Smoking Abstinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01548638
First received: March 5, 2012
Last updated: July 1, 2014
Last verified: June 2014
Results First Received: October 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nicotine Addiction
Intervention: Drug: Galantamine ER

  Participant Flow
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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
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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  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 7.1  
Gender  
[units: participants]
 
Female     5  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     13  



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

5.  Secondary:   Subjective Symptoms - Smoking Behavior, Urges, Mood, Nicotine Withdrawal   [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided


Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01548638     History of Changes
Other Study ID Numbers: 814947
Study First Received: March 5, 2012
Results First Received: October 30, 2013
Last Updated: July 1, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board