Smoking Response Inhibition Training

NCT02218944 | Unknown

• 1 other identifier: SM14171
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Interventions

Response Inhibition Training 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.

Also known as: Stop-signal Task; Go/No-Go Task

Response Inhibition Training: A; Response Inhibition Training: B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Dakota State University: lead

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58078, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Robert D Dvorak, PhD

  Amy Scott, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

US (1)