Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

Conditions:Smoking Cessation, Psychiatric, Tobacco Consumers
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Age Range:18 - 70
Start Date:October 7, 2016
End Date:October 2019
Contact:Lauren Tursi

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This study will examine extended exposure to cigarettes varying in nicotine content among
people with affective disorders. People with affective disorders are at an increased risk for
smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at
significantly increased risk for smoking-related adverse health consequences. Studies testing
an innovative regulatory strategy of reducing the nicotine content of cigarettes to a
non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced
toxicant exposure, and increased cessation) in the general population of smokers. However,
these studies have uniformly excluded vulnerable populations like people with current
affective disorders, who may respond differently considering their greater vulnerability to
smoking and nicotine dependence. Thus, little is known scientifically about how this highly
vulnerable subgroup of smokers may respond to a nicotine reduction policy. This project is
designed to fill that substantial knowledge gap.

Inclusion Criteria:

- 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 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 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, 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 Criteria:

- 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
We found this trial at
85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
Phone: 802-656-8859
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
Burlington, VT
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69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Jennifer W Tidey, PhD
Phone: 401-863-6418
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
Providence, RI
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