Clinical trial NCT02218944: Smoking Response Inhibition Training
Official title: Response Inhibition Training in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: North Dakota State University
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Smoking relapse
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: North Dakota State University
state: North Dakota
Study officials:
affiliation: Amy Scott, PhD
name: Robert D Dvorak, PhD
role: PRINCIPAL_INVESTIGATOR
References: