A Study to Help People Quit Smoking.

NCT ID: NCT01880099

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo compared to 8mg of Galantamine

galantamine 8mg

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

Group Type: ACTIVE_COMPARATOR

Galantamine 8mg

Intervention Type: DRUG

8mg of galantamine compared to placebo

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.

Group Type: ACTIVE_COMPARATOR

Galantamine 16mg

Intervention Type: DRUG

16mg of galantamine compared to placebo

Interventions

placebo

placebo compared to 8mg of Galantamine

Intervention Type: DRUG

Galantamine 8mg

8mg of galantamine compared to placebo

Intervention Type: DRUG

Galantamine 16mg

16mg of galantamine compared to placebo

Intervention Type: DRUG

Other Intervention Names

sugar pill; Acetylcholinesterase inhibitors, Galantamine ER,; Razadyne, Razadyne ER, Reminyl; Acetylcholinesterase inhibitors, Galantamine ER,; Razadyne, Razadyne ER, Reminyl

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Sofuoglu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Veteran Affairs

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R21DA034815-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1306012154

Identifier Type: -

Identifier Source: org_study_id