Cognitive Training for Nicotine Dependence

Tobacco Use Disorder Clinical Trial

Official title:

Cognitive Training for Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252966
• Other study ID #: 812429
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: January 12, 2017
• Start date: March 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.

All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Addiction
• Tobacco Use Disorder

Intervention

Behavioral:
• Cognitive Training
The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
• Control training
The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.

Locations

Country	Name	City	State
United States	Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point-prevalence Abstinence at End of Treatment	Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.	End of treatment (Week 12)
Secondary	Point-prevalence Abstinence at 6-month Follow-up	Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.	6 month follow-up
Secondary	Cognitive Performance (Working Memory)	Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.	Baseline and Week 12 (EOT)
Secondary	Cognitive Performance (Response Inhibition)	Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word "PRESS" in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change.	Baseline and Week 12 (EOT)
Secondary	Cognitive Performance (Attention)	Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.	Baseline and Week 12 (EOT)