An interventional study of Approach Bias Retraining and SHAM Training in Nicotine Dependence, sponsored by Jasper A. Smits. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Jasper A. Smits · Not applicable, Interventional, and Treatment
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Among 799 studies in Tobacco Use Disorder with a site in United States — 75 open to participants now, 91 under way, 5 of them phase 3. Tobacco Use Disorder · United States.
Among the 799 studies in Tobacco Use Disorder with a site in United States, this one is the 341st largest by enrollment of the 736 interventional ones that give a count, is one of 26 that started in 2017, is one of 364 with no phase, and was the 550th registered.
1,028 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
Browse Tobacco Use Disorder studies →75 of the 799 studies in Tobacco Use Disorder with a site in United States are open now. Recruiting first, the newest first:
Florida International University · Sites in United States
Ages 14–18
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 21+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 21+
VA Office of Research and Development · Sites in United States
Yale University · Sites in United States
Ages 21–44 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 95 Tobacco Use Disorder studies recruiting now, 42 (44%) set no upper age limit and 50 (53%) stop at 75 or younger; 6 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
799 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 110 · Phase 2 177 · Phase 3 66 · Phase 4 71
First in 1990; this study’s year is marked. 26 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is close to the median of 90 across 893 interventional studies indexed under Tobacco Use Disorder.
Median enrollment 84 across the 736 interventional studies, 112 across the 58 observational. Of the 656 that completed or were terminated, 344 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 799 have an industry lead sponsor. The 10 most frequent:
Jasper A. Smits is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Jasper A. Smits has 5 studies filed under Tobacco Use Disorder — fewer than ten, so there is no comparison to draw.
40 of the studies in Tobacco Use Disorder with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT06837220University of ChicagoImplementation of Tobacco Cessation Programming at Community Behavioral Health Sites | 2026-12 |
| NCT05452772Johns Hopkins University5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder | 2026-12 |
| NCT07322432VapeAwayThe CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction | 2026-12 |
| NCT06617312University of California, Los AngelesExamining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity | 2026-12 |
Add all 40 to your calendar (.ics) → With an account.
Among the 799 studies in Tobacco Use Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 Training
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.
Time frame: 18 weeks
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.
Time frame: 18 weeks
Participants were recruited via three main channels: 1) fliers and pamphlets in community-based organizations and bulletin boards; 2) social media outlets; and 3) UT Austin resources such as UT Events and digital screen ads.
| Milestone | Approach Bias Retraining Group | Control Group |
|---|---|---|
| Started | 46 | 50 |
| Completed | 37 | 38 |
| Not completed | 9 | 12 |
| Withdrew: Lost to follow-up | 9 | 12 |
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.
| proportion abstinent | Approach Bias Retraining Group | Control Group |
|---|---|---|
| Smoking Status at 3-month Follow Up | .57 | .39 |
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.
| units on a scale | Approach Bias Retraining Group | Control Group |
|---|---|---|
| Approach Bias After 7-week Intervention Phase | 210 ± 26.04 | 39 ± 24.86 |
Collected over 18 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Approach Bias Retraining Group | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Control Group | 0/50 (0%) | 0/50 (0%) | 3/50 (6%) |
| Event | Approach Bias Retraining Group | Control Group |
|---|---|---|
| SeizureNervous system disorders | 0/46 | 1/50 |
| Skin IrritationSkin and subcutaneous tissue disorders | 0/46 | 1/50 |
| High Blood PressureVascular disorders | 0/46 | 1/50 |
| Dizziness, Nausea, Physical DiscomfortGeneral disorders | 0/46 | 1/50 |
| Age, Categorical(Participants) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 50 | 96 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| Mean | 42.8 ± 10.8 | 43.3 ± 10.7 | 43.1 ± 10.7 |
| Sex: Female, Male(Participants) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| Female | 25 | 28 | 53 |
| Male | 21 | 22 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 11 |
| Not Hispanic or Latino | 40 | 45 | 85 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 41 | 42 | 83 |
| More than one race | 4 | 5 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| United States | 46 | 50 | 96 |
| Baseline Approach Bias(units on a scale) | Approach Bias Retraining Group | Control Group | Total |
|---|---|---|---|
| Mean | 6.4 ± 239.2 | 139.5 ± 214.4 | 75.7 ± 235.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Oct 2021, 46 months.
Results were first posted in Jun 2023, 1 year 8 months after primary completion.
Of 256 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's 46 months is above that.
Counting every sponsor, half of 266 studies reached it within 32 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Jasper A. Smits