Status:
COMPLETED
Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
Lead Sponsor:
Brown University
Collaborating Sponsors:
University of Vermont
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, a...
Detailed Description
The primary overall objective of these studies is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in adult men and women with affective disorders using a 3-con...
Eligibility Criteria
Inclusion
- Male or Female
- Ages 18-70
- Past-year major depressive disorder, dysthymic disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobia, or panic disorder with or without agoraphobia, based on Mini-Neuropsychiatric Interview (MINI) structured interview, OR lifetime diagnosis of one of the above based on MINI with a self-report of currently receiving treatment (prescribed psychoactive medication, behavioral therapy, etc.)
- Report smoking 5 or more cigarettes per day for the past year
- Provide an intake breath Carbon Monoxide (CO) sample \> 8 ppm
- Be without current substance abuse/dependence other than nicotine
- Be sufficiently literate to complete the research-related tasks
- Be in good physical health without serious illness or change in health in the past 3 months as determined by the licensed medical professional at each site
- Not pregnant or nursing and report using oral, implant, patch, ring, intrauterine device (IUD), injection or barrier contraceptives or report being surgically sterile or post-menopausal
- Report no significant use of other tobacco or nicotine products within the past month (\> 9 days in the past 30)
Exclusion
- Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
- Exclusive use of roll-your-own cigarettes
- Planning to quit smoking in the next 30 days
- A quit attempt in the past 30 days resulting in \> 3 days of abstinence
- Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once)
- Breath alcohol level \> 0.01 (participants with a positive screen will be allowed to re-screen once)
- Self-report of binge drinking alcohol (\> 9 days in the past 30, 4/5 drinks in 2 hours for women/men
- Systolic blood pressure below 90 mmHg or greater than or equal to 160 mmHg (participants outside the range will be allowed to re-screen once)
- Diastolic blood pressure below 50 mmHg or greater than or equal to 100 mmHg (participants outside the range will be allowed to re-screen once)
- Breath CO \> 80 ppm
- Heart rate below 45 or greater than or equal to 115 bpm (participants outside the range will be allowed to re-screen once)
- Currently seeking treatment for smoking cessation
- Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion for treatment of depression will be allowed)
- Unstable psychiatric conditions (psychiatric medication changes in the past 4 weeks)
- Current symptoms of psychosis, dementia or mania
- Suicidal ideation in past month
- Suicide attempt in past 6 months
- Participation in another research study in the past 30 days
Key Trial Info
Start Date :
October 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
775 Patients enrolled
Trial Details
Trial ID
NCT02232737
Start Date
October 7 2016
End Date
January 14 2019
Last Update
December 7 2022
Active Locations (2)
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1
Brown University
Providence, Rhode Island, United States, 02912
2
University of Vermont
Burlington, Vermont, United States, 05401