Clinical trial NCT02046551: Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Nicotine Dependence
Keywords: nicotine
smoking
atomoxetine
stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2014-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Nicotine Effects Questionnaire
timeFrame: Day 5
measure: Nicotine Effects Questionnaire
timeFrame: Day 17
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression (CES-D) scale
timeFrame: Day 5
measure: Positive and Negative Affect Schedule (PANAS )
timeFrame: Day 5
measure: The Profile of Mood States (POMS)
timeFrame: Day 5
measure: Center for Epidemiologic Studies Depression (CES-D) scale
timeFrame: Day 17
measure: Positive and Negative Affect Schedule (PANAS )
timeFrame: Day 17
measure: The Profile of Mood States (POMS)
timeFrame: Day 17
measure: Symptom Checklist Form (SCF)
timeFrame: Day 5
measure: Symptom Checklist Form (SCF)
timeFrame: Day 17
measure: Nicotine Withdrawal Symptom Checklist (NWSC)
timeFrame: Day 5
measure: Nicotine Withdrawal Symptom Checklist (NWSC)
timeFrame: Day 17
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven Veterans Affairs
state: Connecticut
Study officials:
affiliation: Yale University
name: Albert Arias, MD
role: PRINCIPAL_INVESTIGATOR
References: