NCT03170258

Self-activation in Individuals With and Without Nicotine Dependence

Terminated NA Results posted Last updated 5 September 2024

What this trial tests

NA trial testing Neurofeedback (from fMRI and/or EEG) in Addiction Nicotine in 46 participants. Terminated before completion.

Timeline

28 February 2018

Primary endpoint
28 June 2022

5 July 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	46
Start date	28 February 2018
Primary completion	28 June 2022
Estimated completion	5 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Neurofeedback (from fMRI and/or EEG)

Conditions studied

• Addiction Nicotine — all drugs for Addiction Nicotine →

Sponsor

Duke University

Who can join

Adults 18 to 45, any sex, with Addiction Nicotine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Reward-related Brain Activation as Measured by fMRI Primary · Changes will be assessed across the task (~30 minutes) during the neurofeedback visit

The investigators will examine the change in brain activation in the target region (e.g., VTA) during the task. This includes prior to, during, and following real-time neurofeedback. Reported is the percent signal change from baseline (last 3 volumes of prior count condition).

Group	Value	95% CI
Reward-related Brain Region Feedback	0.4864	± 0.4798

Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power Primary · Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback

The investigators will examine the change in brain activation in the target region (e.g., VTA) during the task. This includes prior to, during, and following real-time neurofeedback. Reported here is the change from baseline (prior to real-time neurofeedback) and \~30 minutes following real-time neurofeedback. The ratio of Beta to Theta power indicates the level of active brainwave activity (Beta) versus the level of resting brainwave activity (Theta).

Group	Value	95% CI
Reward-related Brain Region Feedback	0.13	± 0.12

Onset to Smoking a Cigarette Secondary · up to 30 minutes following the neurofeedback session

The time (in minutes) to when participants smoke their first cigarette following the MRI session

Group	Value	95% CI
Reward-related Brain Region Feedback	1.00	± 1.41

Sponsor's own description

The purpose of this study is to see if a non-medication intervention can increase motivation and reward processing to non-drug reward cues (for example, a picture of one's favorite food) in individuals with and without nicotine dependence by observing brain activity using electroencephalography (EEG) and/or functional magnetic resonance imaging (fMRI). The investigators hypothesize that learning to increase brain activity to non-drug cues may improve reward responses and motivation to non-drug cues, and for individuals who smoke, may eventually result in improved smoking cessation outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.