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Cognitive Training for Nicotine Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01252966
First received: December 1, 2010
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

This study will test the effects of strengthening certain mental processes that may affect a smoker's ability to quit smoking through the use of a web-based training program.

All participants will receive 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and be randomized (similar to flipping a coin) to 1 of 2 different training programs. The amount and type of exercises participants will receive in these programs will vary.


Condition Intervention
Tobacco Use Disorder
Smoking Relapse
Cognitive Training
Nicotine Addiction
Behavioral: Cognitive Remediation Training (CRT)
Behavioral: Standard Care (SC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cognitive Training for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Point-prevalence abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Approximately 6 months after your target quit date, you will be asked to complete a brief telephone survey to assess the number of cigarettes smoked since your end of treatment. Some participants completing this 6-month follow up survey may also be invited to the Center for a brief visit to complete a breath sample and provide a 1-teaspoon saliva sample. The samples collected will biochemically verify abstinence.


Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We will analyze data collected and determine if any objective measures of executive function (attention, working memory, and response inhibition) are seen between the two different training programs.

  • Blood-oxygen-level dependent (BOLD) signal change during fMRI cognitive assessments. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Some participants will complete two Functional Magnetic Resonance Imaging (fMRI) brain scans, one before treatment and one after treatment. Both fMRI scans will involve completing cognitive tasks. Data will be analyzed to determine if any changes in brain blood flow occur (BOLD signal change) and if these differences are due to the differences in the two training programs of the study.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation Training (CRT)
The Cognitive Remediation Training (CRT) is a 12-week standardized course of internet-based computerized cognitive exercises designed to buffer smokers against cognitive deficits that increase smoking relapse risk.
Behavioral: Cognitive Remediation Training (CRT)
Cognitive Remediation Training (CRT) is a 12-week standardized course of internet-based computerized cognitive exercises designed to buffer smokers against cognitive deficits that increase smoking relapse risk.
Placebo Comparator: Standard Care (SC)
The Standard Care (SC) arm is a 12-week standardized course of internet-based deep breathing exercises, but do not contain the cognitive exercises designed to buffer smokers against cognitive deficits that increase smoking relapse risk found in the Cognitive Remediation Training.
Behavioral: Standard Care (SC)
Standard Care (SC) is a 12-week standardized course of internet-based deep breathing exercises, but do not contain the cognitive exercises designed to buffer smokers against cognitive deficits that increase smoking relapse risk found in the Cognitive Remediation Training.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
  2. Plan to live in the area for at least the next 8 months.
  3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
  4. Able to communicate fluently in English (speaking, writing, and reading).
  5. Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection.
  6. Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252966

Contacts
Contact: Benjamin Albelda, BS 215-746-7173 albeldab@mail.med.upenn.edu
Contact: Paul Sanborn, MS 215-746-7150 sanborn@mail.med.upenn.edu

Locations
United States, Pennsylvania
Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Benjamin Albelda, BS    215-746-7173    albeldab@mail.med.upenn.edu   
Contact: Paul Sanborn, MS    215-746-7150    sanborn@mail.med.upenn.edu   
Principal Investigator: Caryn Lerman, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Caryn Lerman, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01252966     History of Changes
Other Study ID Numbers: 812429, R01DA030819
Study First Received: December 1, 2010
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Tobacco
Smoking
Cognition
Behavioral Training
Relapse

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 23, 2014