A Study to Help People Quit Smoking.
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/6/2016 |
| Start Date: | December 2013 |
| End Date: | December 2015 |
Cholinergic Enhancement as a Treatment for Nicotine Addiction
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.
(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.
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.
To date final data collection was completed in December of 2015, currently this study is in
data analysis. (July 2016)
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.
To date final data collection was completed in December of 2015, currently this study is in
data analysis. (July 2016)
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.
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