Brain Activity and Smoking Cessation

NCT01186055 | Completed

• 2 other identifiers: 811325P50CA143187
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Keywords

Smoking Relapse; Nicotine Abstinence

Outcome Measures

Primary Outcomes (1)

• Association between brain activity following nicotine abstinence and quit rates after 8 weeks post-target quit date

  The correlation between cerebral blood flow or BOLD signal changes and days to relapse will be examined using separate GLM analyses. For this analysis, each session's (abstinence, smoking) mean CBF (or BOLD signal) will be calculated for the ROIs. Mean values from each ROI will be used as predictors in a longitudinal logistic regression model of quitting success.

  8 weeks

Secondary Outcomes (2)

• Behavioral performance and BOLD signal change during neurocognitive tasks

  24 hours

• Cravings for Cigarettes

  24 hours

Study Arms (1)

Smoking Cessation Counseling

Individuals will receive individual and group counseling for 8 weeks (6 visits) while they quit smoking.

Behavioral: Smoking Cessation Counseling

Interventions

Smoking Cessation Counseling BEHAVIORAL

Participants shall all receive 8 weeks (6 weeks) of group or individual counseling during their quit attempt.

Also known as: Counseling

Smoking Cessation Counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 treatment seeking smokers ages 18 to 65 who report smoking at least 10 cigarettes per day for at least the last 6-months.

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.
• 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.
• 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,

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

3535 Market Street, Suite 4100, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Center for Interdisciplinary Research on Nicotine Addiction

Biospecimen

Retention: SAMPLES WITH DNA

1. A 2ml saliva sample for DNA collection \& genotyping (Oragene™). 2. A 5ml saliva sample to assess nicotine metabolites (e.g. cotinine and 3-hydroxycotinine).

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Counseling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Caryn Lerman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 20, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (1)