Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers

Yale University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Nicotine Dependence

Treatments

Drug: Placebo

Drug: Atomoxetine

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02046551

1305012021

Details and patient eligibility

About

The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

female and male smokers, not treatment seeking, aged 18 to 55 years;
history of smoking daily for the past 12 months, at least 5 cigarettes daily;
CO level > 10ppm;
for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion criteria

history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
known allergy to atomoxetine