Cognitive Training for Nicotine Dependence

NCT01252966 | Completed Results DMC

• 1 other identifier: 812429
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder; Nicotine Addiction

Keywords

Tobacco; Smoking; Cognition; Behavioral Training; Relapse

Outcome Measures

Primary Outcomes (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.

  End of treatment (Week 12)

Secondary Outcomes (4)

• Point-prevalence Abstinence at 6-month Follow-up

  6 month follow-up

• Cognitive Performance (Working Memory)

  Baseline and Week 12 (EOT)

• Cognitive Performance (Response Inhibition)

  Baseline and Week 12 (EOT)

• Cognitive Performance (Attention)

  Baseline and Week 12 (EOT)

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Participants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling.

Behavioral: Cognitive Training

Control Training

PLACEBO COMPARATOR

Participants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling

Behavioral: Control training

Interventions

Cognitive Training BEHAVIORAL

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

Cognitive Training

Control training BEHAVIORAL

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.

Control Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 28694338 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Recurrence

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Benjamin Albelda (Project Manager)
• Organization: University of Pennsylvania (Perelman School of Medicine)

albeldab@mail.med.upenn.edu

2157467173

Study Officials

• Caryn Lerman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: March 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 2, 2017

Record last verified: 2017-01

Locations

US (1)