Nicotine DependenceNCT03325777
Approach Bias Retraining to Augment Smoking Cessation
A study testing Approach Bias Retraining in people with Nicotine Dependence, run by Jasper A. Smits at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Approach Bias Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 8 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
The integrated intervention involves seven weekly 60-minute therapy sessions. The each therapy session involves 15 minutes of computerized approach bias retraining and 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 therapy session, the study therapist will collect relevant smoking assessments and begin 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.
Participants will begin therapy sessions 2-6 by completing the computerized approach bias retraining task. At session 2, 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 6. 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 therapy sessions 2-5, the 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).
At session 6, participants will initiate a quit attempt. 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 6, 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 7 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 9, 1- month (week 10), 2-month (week 14), and 3-month (week 18). The primary function of these visits is to gather information about the participants smoking habits post treatment.
- Conditions
- Nicotine Dependence
- Being tested
- Approach Bias Retraining, SHAM Training
- Keywords
- Cigarettes, Tobacco Use
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach Bias RetrainingBehavioural
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.
SHAM TrainingBehavioural
SHAM Training
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: SHAM Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Secondary outcomes (1)
Approach Bias After 7-week Intervention Phase
The approach-avoidance task (AAT) is an implicit task that measures people's behavioral tendencies to approach or avoid stimuli in the environment.
The AAT assessment was used to calculate approach bias tendency at the start of each training session. A positive value indicates a relatively stronger avoidance tendency in response to stimuli.
The difference in response latencies is standardized by dividing an individual's difference in reaction time by a personalized standard deviation of the latencies.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start29 Nov 2017
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper A. Smits
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Jasper A. Smits, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325777
- Sponsor's protocol ID
- 2017-04-0006
- Status last verified
- May 2023
- First submitted
- 25 Oct 2017
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach Bias Retraining to Augment Smoking Cessation
- ClinicalTrials.gov ID
- NCT03325777
- Acronym / sponsor ID
- 2017-04-0006
- Conditions
- Nicotine Dependence
- Keywords
- Cigarettes, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jasper A. SmitsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 therapy sessions. The each therapy session involves 15 minutes of computerized approach bias retraining and 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 therapy session, the study therapist will collect relevant smoking assessments and begin 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.
Participants will begin therapy sessions 2-6 by completing the computerized approach bias retraining task. At session 2, 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 6. 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 therapy sessions 2-5, the 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).
At session 6, participants will initiate a quit attempt. 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 6, 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 7 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 9, 1- month (week 10), 2-month (week 14), and 3-month (week 18). The primary function of these visits is to gather information about the participants smoking habits post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Approach Bias Retraining Group | Experimental | Behavioral: Approach Bias RetrainingIndividuals 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). |
| Control Group | Sham comparator | Behavioral: SHAM TrainingIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Approach Bias RetrainingThe 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. | Behavioural | Approach Bias Retraining Group |
| SHAM TrainingSHAM Training | Behavioural | Control Group |
Primary outcome
Smoking Status at 3-month Follow Up
Time frame: 18 weeks
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.
1 secondary outcome
Approach Bias After 7-week Intervention Phase
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach Bias Retraining in people with Nicotine Dependence, run by Jasper A. Smits 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 5 inclusion and 6 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 15 Jun 2026. 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 9 Jun 2023). 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?
Smoking Status at 3-month Follow Up (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.