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Tobacco Use DisorderNCT01252966

Cognitive Training for Nicotine Dependence

A study testing Cognitive Training in people with Tobacco Use Disorder and Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tobacco Use Disorder, Nicotine Addiction
What is being tested?
Cognitive Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
1 siteUnited States
Study dates
Mar 2011to Sep 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
  • Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Being tested
Cognitive Training, Control training
Keywords
Tobacco, Smoking, Cognition, Behavioral Training, Relapse
Medical subject headings
Tobacco Use Disorder, Smoking, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TrainingBehavioural

    The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.

  • Control trainingBehavioural

    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.

Study groups in NCT01252966
Study groupRoleWhat they receive
Cognitive TrainingExperimentalParticipants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling.
Receives: Behavioral: Cognitive Training
Control TrainingPlacebo comparatorParticipants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling
Receives: Behavioral: Control training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: End of treatment (Week 12)

Secondary outcomes (4)
  1. 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.

    Measured: 6 month follow-up

  2. 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.

    Measured: Baseline and Week 12 (EOT)

  3. 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.

    Measured: Baseline and Week 12 (EOT)

  4. 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.

    Measured: Baseline and Week 12 (EOT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252966
Sponsor's protocol ID
812429
Status last verified
Jan 2017
First submitted
1 Dec 2010
Last updated
16 Jan 2017
Data monitoring committee
Yes

Publications

  • Kable JW, Caulfield MK, Falcone M, McConnell M, Bernardo L, Parthasarathi T, Cooper N, Ashare R, Audrain-McGovern J, Hornik R, Diefenbach P, Lee FJ, Lerman C. No Effect of Commercial Cognitive Training on Brain Activity, Choice Behavior, or Cognitive Performance. J Neurosci. 2017 Aug 2;37(31):7390-7402. doi: 10.1523/JNEUROSCI.2832-16.2017. Epub 2017 Jul 10.

    PubMed 28694338

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Training in people with Tobacco Use Disorder and Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Point-prevalence Abstinence at End of Treatment (time frame: End of treatment (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252966, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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