Smoking CessationNCT02218944
Smoking Response Inhibition Training
A study testing Response Inhibition Training in people with Smoking Cessation, run by North Dakota State University at 1 site in United States.
Trial summary
The current study tests a response inhibition retraining program, implemented on a mobile device, as a mechanism to increase relapse prevention during a smoking cessation attempt. Study participants (n = 150) are randomly assigned to a control, benign, or intervention condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Response Inhibition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals 18-45 years old, who smoke at least 10 cigarettes/day, score 5 or higher on the Fägerstrom Test of Nicotine Dependence, express a desire to quit, and have no current psychiatric diagnoses.
Who cannot join
- Individuals will be ineligible to participate if they have used other tobacco products (e.g., smokeless tobacco) on more than 5 days in the past month, intend to quit smoking using pharmacotherapy, or are non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58078
About this study
Official title: Response Inhibition Training in Smoking Cessation
The current study tests a response inhibition retraining program, implemented on a mobile device, as a mechanism to increase relapse prevention during a smoking cessation attempt. Study participants (n = 150) are randomly assigned to a control, benign, or intervention condition. They complete 2 weeks of response inhibition retraining, and then engage in a cessation attempt. It is hypothesized that individuals who receive the intervention will have a decreased likelihood of relapse following the cessation attempt. In addition, it is hypothesized that this is due to decreases in implicit smoking motivation as a function of the response inhibition training.
Read the detailed description
Smoking is the leading preventable cause of death and disease in the U.S. Each year approximately 30% of smokers try to quit, with the vast majority of attempts (~90%) ending in relapse. This is complicated by treatment barriers related to cost and accessibility. Identifying cost effective ways to aide in cessation success, which can be widely disseminated, remains vitally important. According to the dual-process model of substance use, addiction develops via an imbalance between effortful control and automatic psychological processes. The affective processing model suggests that during withdrawal, automatic psychological processes increase implicit drug seeking motivation. Implicit motivation is hypothesized as the underlying mechanism through which automatic psychological processes exert control over behavior. Research suggests that behavioral impulse control may attenuate the association between implicit motivation and substance use. Response inhibition, one form of behavioral impulse control, is the ability to inhibit behavioral responses to salient approach cues. Smokers tend to have less behavioral impulse control. In addition, poor behavioral impulse control makes individuals more vulnerable to various risk factors associated with relapse (e.g., positive expectancies, higher craving during abstinence, etc.). Improving smoking relevant behavioral impulse control may affect multiple indices of relapse. Research in cognitive retraining has shown that response inhibition can be modified through training. Recently this has been extended to training using mobile devices. The development of mobile interventions which specifically target underlying mechanisms of addiction may provide a novel adjunct to current cessation programs. The current proposal builds on previous research by implementing a response inhibition training paradigm in the context of a cessation trial. It is hypothesized that this task will reduce the likelihood of relapse following a quit attempt. Furthermore, it is hypothesized that training effects will operate via decreases in implicit motivation and global craving. If successful, the current study will provide evidence for a relapse prevention tool that can (1) increase overall cessation success and (2) be widely and easily dispersed.
- Conditions
- Smoking Cessation
- Being tested
- Response Inhibition Training
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response Inhibition TrainingBehavioural
Also called Stop-signal Task; Go/No-Go Task
The primary purpose of this research is to examine the feasibility and efficacy of a smoking specific response inhibition training program in the context of a quit attempt. The task is based on a modified stop-signal task. The study utilizes a one-way nested design with three conditions.
| Study group | Role | What they receive |
|---|---|---|
| Response Inhibition Training: A | Experimental | In the experimental condition, 20% of responses are no-go, with the majority of no-go responses paired with smoking images. Receives: Behavioral: Response Inhibition Training |
| Response Inhibition Training: B | Active comparator | In the active comparator condition, 20% of responses are no-go trials, with no-go responses spread evenly across the various images. Receives: Behavioral: Response Inhibition Training |
| Benign | Placebo comparator | A benign condition has also been added to control for the possibility that response inhibition training, regardless of target, increases behavioral control and hence decreases relapse likelihood. The benign condition has 50% no-go trials, with no-go responses spread evenly across images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking relapse
A relapse is defined as a resumption of smoking behavior, following a cessation attempt, with the acknowledgement that the study participant is no longer trying to quit smoking. Abstinence is verified with Cotinine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D Dvorak, PhD, Principal investigator, Amy Scott, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218944
- Sponsor's protocol ID
- SM14171
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Inhibition Training in Smoking Cessation
- ClinicalTrials.gov ID
- NCT02218944
- Acronym / sponsor ID
- SM14171
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study tests a response inhibition retraining program, implemented on a mobile device, as a mechanism to increase relapse prevention during a smoking cessation attempt. Study participants (n = 150) are randomly assigned to a control, benign, or intervention condition. They complete 2 weeks of response inhibition retraining, and then engage in a cessation attempt. It is hypothesized that individuals who receive the intervention will have a decreased likelihood of relapse following the cessation attempt. In addition, it is hypothesized that this is due to decreases in implicit smoking motivation as a function of the response inhibition training.
Detailed description
Smoking is the leading preventable cause of death and disease in the U.S. Each year approximately 30% of smokers try to quit, with the vast majority of attempts (~90%) ending in relapse. This is complicated by treatment barriers related to cost and accessibility. Identifying cost effective ways to aide in cessation success, which can be widely disseminated, remains vitally important. According to the dual-process model of substance use, addiction develops via an imbalance between effortful control and automatic psychological processes. The affective processing model suggests that during withdrawal, automatic psychological processes increase implicit drug seeking motivation. Implicit motivation is hypothesized as the underlying mechanism through which automatic psychological processes exert control over behavior. Research suggests that behavioral impulse control may attenuate the association between implicit motivation and substance use. Response inhibition, one form of behavioral impulse control, is the ability to inhibit behavioral responses to salient approach cues. Smokers tend to have less behavioral impulse control. In addition, poor behavioral impulse control makes individuals more vulnerable to various risk factors associated with relapse (e.g., positive expectancies, higher craving during abstinence, etc.). Improving smoking relevant behavioral impulse control may affect multiple indices of relapse. Research in cognitive retraining has shown that response inhibition can be modified through training. Recently this has been extended to training using mobile devices. The development of mobile interventions which specifically target underlying mechanisms of addiction may provide a novel adjunct to current cessation programs. The current proposal builds on previous research by implementing a response inhibition training paradigm in the context of a cessation trial. It is hypothesized that this task will reduce the likelihood of relapse following a quit attempt. Furthermore, it is hypothesized that training effects will operate via decreases in implicit motivation and global craving. If successful, the current study will provide evidence for a relapse prevention tool that can (1) increase overall cessation success and (2) be widely and easily dispersed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Response Inhibition Training: A | Experimental | Behavioral: Response Inhibition TrainingIn the experimental condition, 20% of responses are no-go, with the majority of no-go responses paired with smoking images. |
| Response Inhibition Training: B | Active comparator | Behavioral: Response Inhibition TrainingIn the active comparator condition, 20% of responses are no-go trials, with no-go responses spread evenly across the various images. |
| Benign | Placebo comparator | –A benign condition has also been added to control for the possibility that response inhibition training, regardless of target, increases behavioral control and hence decreases relapse likelihood. The benign condition has 50% no-go trials, with no-go responses spread evenly across images. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals 18-45 years old, who smoke at least 10 cigarettes/day, score 5 or higher on the Fägerstrom Test of Nicotine Dependence, express a desire to quit, and have no current psychiatric diagnoses.
Key exclusion criteria (1 listed)
- Individuals will be ineligible to participate if they have used other tobacco products (e.g., smokeless tobacco) on more than 5 days in the past month, intend to quit smoking using pharmacotherapy, or are non-English speaking.
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 |
|---|---|---|
| Response Inhibition TrainingAlso: Stop-signal Task; Go/No-Go TaskThe primary purpose of this research is to examine the feasibility and efficacy of a smoking specific response inhibition training program in the context of a quit attempt. The task is based on a modified stop-signal task. The study utilizes a one-way nested design with three conditions. | Behavioural | Response Inhibition Training: A, Response Inhibition Training: B |
Primary outcome
Smoking relapse
Time frame: 6 months
A relapse is defined as a resumption of smoking behavior, following a cessation attempt, with the acknowledgement that the study participant is no longer trying to quit smoking. Abstinence is verified with Cotinine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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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.
Robert D Dvorak, PhD principal investigator
Amy Scott, PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response Inhibition Training in people with Smoking Cessation, run by North Dakota State University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2014. 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?
Results are not available in the source record.
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 relapse (time frame: 6 months). 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 8 Oct 2014.