Cognitive Training for Nicotine Dependence
This study is currently recruiting participants.
Verified February 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01252966
First received: December 1, 2010
Last updated: February 18, 2013
Last verified: February 2013
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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: | 340 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | June 2014 (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:
- Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Plan to live in the area for at least the next 8-months.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Able to communicate fluently in English (speaking, writing, and reading).
- Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection.
Contacts and Locations
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: Angela Pinto, MBA | 215-746-7171 | pintoa@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: Angela Pinto, MBA 215-746-7171 pintoa@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: | February 18, 2013 |
| 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 Smoking Behavior, Addictive Substance-Related Disorders Mental Disorders Habits Compulsive Behavior Impulsive Behavior Nicotine Ganglionic Stimulants |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013