Approach Bias Retraining to Augment Smoking Cessation

NCT03325777 | Completed Results DMC

• 1 other identifier: 2017-04-0006
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

Cigarettes; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Smoking Status at 3-month Follow Up

  The primary outcomes were 7-day point-prevalence abstinence (PPA) and prolonged abstinence (PA) at 3-month follow-up (week 18). PPA was defined as self-report of no smoking (not even a puff) during the previous 7 days. Failure to maintain PA at any assessment was defined as smoking on 7 consecutive days or smoking at least once each week over the last 2 consecutive weeks. PPA and PA were assessed by study staff at each appointment using sequential timeline follow-back interviews and biochemically verified by expired carbon monoxide (CO; ≤4 ppm) at each assessment as well as by saliva cotinine (≤10 ng/mL) at weeks 14 and 18. The outcomes in the table below show what percentage of participants remained abstinent at the 3-month follow-up.

  18 weeks

Secondary Outcomes (1)

• Approach Bias After 7-week Intervention Phase

  18 weeks

Study Arms (2)

Approach Bias Retraining Group

EXPERIMENTAL

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).

Behavioral: Approach Bias Retraining

Control Group

SHAM COMPARATOR

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.

Behavioral: SHAM Training

Interventions

Approach Bias Retraining BEHAVIORAL

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.

Approach Bias Retraining Group

SHAM Training BEHAVIORAL

SHAM Training

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

This was a pilot randomized trial and thus underpowered to detect smaller effects. Second, follow-up assessment was limited to 3-months post quit attempt, and thus cannot make inferences with respect to long-term efficacy. Third, most participants were White (86.5%). An important next step in intervention development is a larger follow-up randomized clinical trial that can test the generalizability and durability of treatment effects

Results Point of Contact

• Title: Dr. Jasper Smits
• Organization: The University of Texas at Austin

smits@utexas.edu

512-475-8095

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: November 29, 2017
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)