A Study to Help People Quit Smoking.

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.

• placebo (Drug), also known as sugar pill: placebo compared to 8mg of Galantamine
• Galantamine 8mg (Drug), also known as Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl: 8mg of galantamine compared to placebo
• Galantamine 16mg (Drug), also known as Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl: 16mg of galantamine compared to placebo

Primary outcomes

• Smoking Choice Procedure [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.

Sex: All, ages: 18 Years to 55 Years

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.

Participant flow

Outcome results

• Smoking Choice Procedure (Primary), Mean, # of choices to smoke (out of 10): Placebo 3.00 +/- 3.08; Galantamine 8mg 1.00 +/- 1.00; Galantamine 16mg 0.85 +/- 1.35

Adverse events

Time frame: 7 weeks

Other adverse events by term

• Mehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Yale University

NIH grants: R21DA034815