- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218944
Smoking Response Inhibition Training
October 7, 2014 updated by: North Dakota State University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58078
- North Dakota State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Response Inhibition Training: A
In the experimental condition, 20% of responses are no-go, with the majority of no-go responses paired with smoking images.
|
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.
Other Names:
|
Active Comparator: Response Inhibition Training: B
In the active comparator condition, 20% of responses are no-go trials, with no-go responses spread evenly across the various images.
|
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.
Other Names:
|
Placebo Comparator: Benign
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert D Dvorak, PhD, Amy Scott, PhD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
May 1, 2016
Study Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
October 8, 2014
Last Update Submitted That Met QC Criteria
October 7, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- SM14171
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Response Inhibition Training
-
University of Wisconsin, MilwaukeeCompletedWilliams SyndromeUnited States
-
Babes-Bolyai UniversityCompleted
-
University of Wisconsin, MilwaukeeTrichotillomania Learning CenterCompleted
-
University of Wisconsin, MilwaukeeNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive Disorder | TrichotillomaniaUnited States
-
Karolinska InstitutetCompleted
-
University of Wisconsin, MilwaukeeTourette Association of AmericaCompletedTourette Syndrome | Chronic Tic DisordersUnited States
-
University of Alabama at BirminghamRecruitingMovement DisordersUnited States
-
University of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting
-
William Beaumont Army Medical CenterTerminatedPosttraumatic Stress DisorderUnited States
-
Yale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedAutism Spectrum DisordersUnited States