Smoking Response Inhibition Training

NCT ID: NCT02218944

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-05-31

Brief 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. 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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Response Inhibition Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Response Inhibition Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Response Inhibition Training

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Stop-signal Task; Go/No-Go Task

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D Dvorak, PhD

Role: PRINCIPAL_INVESTIGATOR

Amy Scott, PhD

Locations

North Dakota State University

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

SM14171

Identifier Type: -

Identifier Source: org_study_id