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A Study to Help People Quit Smoking.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880099
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: placebo Drug: Galantamine 8mg Drug: Galantamine 16mg Not Applicable

Detailed Description:
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Placebo Comparator: placebo
Placebo (sugar Pill) will be given daily for 7 weeks.
Drug: placebo
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
Other Names:
  • Acetylcholinesterase inhibitors, Galantamine ER,
  • Razadyne, Razadyne ER, Reminyl

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
Other Names:
  • Acetylcholinesterase inhibitors, Galantamine ER,
  • Razadyne, Razadyne ER, Reminyl




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male smokers, aged 18 to 55 years;
  • history of smoking daily for the past 12 months, at least 10 cigarettes daily;
  • in good health as verified by medical history, screening examination, and screening laboratory tests;
  • for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

  • History of GAL allergy;
  • requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
  • serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
  • abuse of alcohol or any other illicit or prescription drugs;
  • use of any other tobacco products, including smokeless tobacco and nicotine products; and
  • inability to fulfill all scheduled visits and examination procedures throughout the study period.

Information from the National Library of Medicine

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


Locations
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United States, Connecticut
Veteran Affairs
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01880099     History of Changes
Other Study ID Numbers: 1306012154
First Posted: June 18, 2013    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yale University:
addiction
smoking
tobacco
cigarettes
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents