Brain Activity and Smoking Cessation

Completed

Conditions studied: Nicotine Dependence

In brief

In the current study, the investigators propose to test: (1) whether brain activation and connectivity in a resting state, assessed by ASL perfusion MRI, BOLD fMRI, and diffusion tensor imaging (DTI) predicts smoking relapse, and (2) whether brain activation, assessed by BOLD fMRI during performance of neurobehavioral probes for executive cognitive function, stress and cue reactivity, predicts smoking relapse.

Key facts

Study ID

NCT01186055

Run by

University of Pennsylvania

People needed

80

Starts

2010-04-01

Expected to finish

2013-02-01

Last updated by the study team

2013-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 10 cigarettes per day for at least the past 6 months.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form, and are fluent, English-speaking.
• Provide a baseline CO reading greater than 10 parts per million (ppm) at eligibility screening.
• Women of childbearing potential must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation or abstinence from sex) for the duration of the study.

You may not qualify if…

• Smoking Behavior
• Use of chewing tobacco, snuff, or snus.
• Current enrollment or plans to enroll in another research or smoking cessation program in at least the next 7 months.
• Anticipated use (within next 7 months) of other nicotine substitutes or smoking cessation treatments/ medications.
• Provide a baseline CO reading less than or equal to 10ppm.
• Alcohol/Drug Exclusion Criteria:
• Lifetime history of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana or stimulants).
• Current alcohol consumption that exceeds greater than 25 standard drinks/week for men and greater than 20 standard drinks/week for women over the last 6 months.
• Breath alcohol reading (BrAC) greater than or equal to 0.01 at the Eligibility Screening or any fMRI scanning session.
• A positive urine drug screen (cocaine, opiates, benzodiazepines, tri-cyclic antidepressants, amphetamines, methamphetamines, barbiturates, methadone, and phencyclidine) at the Eligibility Screening or any fMRI scanning session.
• Medication Exclusion Criteria:
• Current use or recent discontinuation (within last 2-weeks) of the following psychotropic medications:
• Antipsychotics (typical and atypical),
• Mood-stabilizers,
• Anti-depressants (tricyclics, SSRI's, selective and nonselective MAOIs, Wellbutrin/Zyban),
• Anti-panic agents,
• Anti-obsessive agents,
• Anti-anxiety agents,
• Prescription (e.g., Provigil, Ritalin) or over-the-counter stimulants,
• Diet Pills/Anorectics,
• Systemic Steroids,
• Varenicline,
• Daily use of prescription medications for chronic pain.
• Medical Exclusion Criteria:
• Women who are pregnant, breast-feeding or planning a pregnancy for the duration of the study.

Where it is running

• 3535 Market Street, Suite 4100, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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