Clinical trial NCT01880099: A Study to Help People Quit Smoking.
Official title: Cholinergic Enhancement as a Treatment for Nicotine Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: addiction
smoking
tobacco
cigarettes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Smoking Choice Procedure
timeFrame: Data was acquired during a single test session during week 3 of drug intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Veteran Affairs
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: