A Study to Help People Quit Smoking.
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|ClinicalTrials.gov Identifier: NCT01880099|
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: placebo Drug: Galantamine 8mg Drug: Galantamine 16mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Cholinergic Enhancement as a Treatment for Nicotine Addiction|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Placebo Comparator: placebo
Placebo (sugar Pill) will be given daily for 7 weeks.
placebo compared to 8mg of galatamine
Other Name: sugar pill
Active Comparator: galantamine 8mg
Galantamine extended release (8mg) will be given daily for 7 weeks.
Drug: Galantamine 8mg
8mg of galatamine compared to placebo
Active Comparator: Galantamine 16mg
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Drug: Galantamine 16mg
16mg of galatamine compared to placebo
- Smoking Choice Procedure [ Time Frame: Data was acquired during a single test session during week 3 of drug intervention. ]After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880099
|United States, Connecticut|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D.,Ph.D.||Yale University|