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Approach Bias Retraining to Augment Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03325777
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : May 3, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE October 25, 2017
First Posted Date  ICMJE October 30, 2017
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE November 29, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • Smoking Status [ Time Frame: 17 weeks ]
    Change from baseline in point prevalence abstinence (PPA) and prolonged abstinence (PA) during the intervention (weeks 0-7), at post treatment (week 8), and at 1-month (week 9), 2-month (week 13) and 3-month (week 17) follow-up (i.e., post-quit).
  • Reaction Time on Approach Bias Retraining Task [ Time Frame: 7 weeks ]
    The time between the start of the trial and the picture disappearing from the screen will be recorded. The investigators will look at the change in response times for each individual. The investigators hypothesize that there will be a greater decrease in reaction time for those in the ABR training group.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03325777 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
Urge to Smoke as assessed by the QSU-brief (Questionnaire of Smoking Urges) [ Time Frame: 7 weeks ]
The investigators hypothesize that individuals in the ABR training condition will evidence a greater decrease in urge to smoke relative to those in the SHAM condition.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Approach Bias Retraining to Augment Smoking Cessation
Official Title  ICMJE Approach Bias Retraining to Augment Smoking Cessation
Brief Summary

Tobacco use is the most preventable cause of disease, disability, and death in the United States. Standard smoking cessation care (cognitive behavioral therapy and nicotine replacement therapy), is effective in approximately 20% of the cases, clearly indicating there is substantial room for improvement.

Current work suggests that despite standard interventions, continued substance abuse may result from addictive behaviors governed partly through automatic processes that exert their influence outside conscious control. This is important from a treatment perspective, as we should develop treatments to target implicit processes.

Among a number of promising targets for intervention, cognitive biases are important to address as they have been implicated as maintenance factors for addiction. Approach bias, defined as the automatically activated action tendency to approach smoking-related stimuli, is a relatively novel cognitive bias and has been related to failed smoking cessation. A recently developed task for approach bias assessment is the Approach Bias Retraining (ABR), a computerized joystick task increasingly used to measure automatic approach tendencies in addiction research.

This clinical trial will evaluate a smoking cessation intervention that integrates standard care with approach bias retraining. Results will provide novel information regarding the potential benefits of engaging implicit cognitive biases as a means to augment traditional smoking cessation therapy. This study has the potential to help individuals attempting to quit smoking and, ultimately, provide unique information about the importance of targeting implicit processes to complement standard care.

Detailed Description

The integrated intervention involves seven weekly 60-minute sessions. Each session involves 15 minutes of computerized approach bias retraining followed by 45 minutes of individual cognitive behavioral therapy. In order to maximize adherence, the scheduling of session visits will be individualized to each participant's schedule.

During the first session, the study therapist will begin by orienting the participant to the joystick procedures. The therapist will explain that the joystick task is thought to affect your automatic tendencies to approach or avoid cigarettes. At this time the participant will complete the first session of approach bias retraining. The therapist will then congratulate participants for deciding to quit smoking, review the positive health consequences of quitting, and express their willingness to help the participant succeed. Participants' past quit attempts will be reviewed to identify what strategies contributed to success and what factors hindered their previous attempts and a target quit date will be set for week 5. Lastly, participants will initiate self-monitoring or track each cigarette they smoke through Quit date and note situational cues for smoking (e.g. times of the day, activities while smoking).

During sessions 2-4, participants will begin by completing the computerized task. Therapists will then assist participants in anticipating situations in their lives that will likely place them at risk for relapse, prepare them for the possibility of lapsing, and provide strategies for coping with the potential negative emotional reactions to lapsing. In addition, therapists will advise all participants to avoid or reduce drinking and advise all participants to tell their friends and family about their quit date and will discuss ways to increase social support during the quit attempt. Lastly, therapists will instruct participants in the proper use of the nicotine patch (e.g., placement of patch, use one a day, importance of not smoking while using the patch) and help them prepare for the quit day (e.g., removing all tobacco products from their environment).

Session 5, the day of the quit attempt, will begin with the ABR task. Therapists will provide individual support for participants during this early period of abstinence. This contact will provide the opportunity for more tailored and elaborate discussions of quitting experiences and coping strategies for anticipated high-risk situations. Therapists will also reinforce success and provide support and encouragement for participants who slip and smoke and ask participants to anticipate potential challenges to remaining abstinent from smoking and discuss strategies for coping with those situations. In addition, during this session, therapists will ask participants to discuss social supports for nonsmoking, help to develop strategies for maximizing social support systems and develop participants' skills in requesting behavioral changes from others. Beginning week 5, participants will be instructed to apply one patch daily. Participants will use the full strength 21-mg patch for 6 weeks and then be instructed to taper to the 14-mg patch for the next 1 week, and then to the 7-mg patch for the remaining 1 week.

Session 6 will be the last day that the ABR task is administered. This session will focus primarily on relapse prevention. Therapists will continue with relapse prevention tactics, including provision of social support, avoiding high-risk situations, using social support from friends/co-workers, and maintaining non-smoking lifestyle changes.

Participants will be asked to come in for a brief follow- up visit at week 8, 1- month (week 9), 2-month (week 13), and 3-month (week 17). The primary function of these visits is to gather information about the participants smoking habits post treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Behavioral: Approach Bias Retraining
    The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
  • Behavioral: SHAM Training
    SHAM Training
Study Arms  ICMJE
  • Experimental: Approach Bias Retraining Group
    Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
    Intervention: Behavioral: Approach Bias Retraining
  • Sham Comparator: Control Group
    Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
    Intervention: Behavioral: SHAM Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients ages 18-65 capable of providing informed consent
  • Willing and able to provide informed consent, attend all study visits, and comply with the protocol
  • Daily smoker for at least 1 year
  • Currently smoke an average of at least 5 cigarettes per day
  • Report a motivation to quit smoking of at least 5 on a 10-point scale

Exclusion Criteria:

  • A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
  • Visual or hand-motoric impairments
  • Current use of nicotine replacement therapy
  • Current use of any other pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
  • Current use of tobacco products other than cigarettes
  • Insufficient command of the English language as the treatment manual is written only in English and study staff are not fluent in other languages
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Haley E Conroy, B.A. 512- 471- 5935
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03325777
Other Study ID Numbers  ICMJE 2017-04-0006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account University of Texas at Austin
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP