A Study to Help People Quit Smoking.

Yale University

Status: Completed

Conditions: Nicotine Dependence

Treatments: Drug: placebo; Drug: Galantamine 8mg; Drug: Galantamine 16mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01880099

1306012154

1R21DA034815-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Placebo (sugar Pill) will be given daily for 7 weeks.

Treatment:

Drug: placebo

galantamine 8mg

Active Comparator group

Description:

Galantamine extended release (8mg) will be given daily for 7 weeks.

Treatment:

Drug: Galantamine 8mg

Galantamine 16mg

Active Comparator group

Description:

Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.

Treatment:

Drug: Galantamine 16mg