Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 24
Inclusion Criteria
- female and male smokers, not treatment seeking, aged 18 to 55 years;
- CO level > 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
- ...
- female and male smokers, not treatment seeking, aged 18 to 55 years;
- CO level > 10ppm;
- 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;
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)
- known allergy to atomoxetine
- ...
- 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)
- known allergy to atomoxetine
- 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;
Summary
- Conditions
- Nicotine Dependence
- Type
- Interventional
- Phase
- Phase 1Phase 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 Criteria
- female and male smokers, not treatment seeking, aged 18 to 55 years;
- CO level > 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
- ...
- female and male smokers, not treatment seeking, aged 18 to 55 years;
- CO level > 10ppm;
- 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;
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)
- known allergy to atomoxetine
- ...
- 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)
- known allergy to atomoxetine
- 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;
Tracking Information
- NCT #
- NCT02046551
- Collaborators
- VA Office of Research and Development
- Investigators
- Principal Investigator: Albert Arias, MD Yale University
- Albert Arias, MD Yale University