Smoking Response Inhibition Training

Smoking Cessation Clinical Trial

Official title:

Response Inhibition Training in Smoking Cessation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02218944
• Other study ID #: SM14171
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 14, 2014
• Last updated: October 7, 2014
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2014
• Source: North Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Individuals 18-45 years old, who smoke at least 10 cigarettes/day, score 5 or higher on the Fa¨gerstrom 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	North Dakota State University	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
North Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No