Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
24

Inclusion Criterias

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

Exclusion Criterias

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
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
...
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
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
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;
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;

Summary

Conditions
Nicotine Dependence
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Inclusion Criterias

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

Exclusion Criterias

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
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
...
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
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
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;
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;

Locations

West Haven, Connecticut, 06515
West Haven, Connecticut, 06515

Tracking Information

NCT #
NCT02046551
Collaborators
VA Office of Research and Development
Investigators
  • Principal Investigator: Albert Arias, MD Yale University
  • Albert Arias, MD Yale University