Self-activation in Individuals With and Without Nicotine Dependence

NCT03170258 | Terminated Results DMC FDA Device

• 3 other identifiers: Pro00081458UL1TR00111724393
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Addiction Nicotine

Keywords

real-time fMRI; reward; motivation; dopamine; EEG

Outcome Measures

Primary Outcomes (2)

• Percent Change in Reward-related Brain Activation as Measured by fMRI

  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).

  Changes will be assessed across the task (~30 minutes) during the neurofeedback visit

• Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power

  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).

  Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback

Secondary Outcomes (2)

• Dopamine Availability

  Collected once during the screening visit

• Onset to Smoking a Cigarette

  up to 30 minutes following the neurofeedback session

Study Arms (2)

Reward-related Brain Region Feedback

EXPERIMENTAL

Participants in this group will receive neurofeedback from a reward-related brain area (e.g., VTA, PFC) using EEG and/or fMRI during the experiment.

Device: Neurofeedback (from fMRI and/or EEG)

Noise Control

SHAM COMPARATOR

Participants in this group will receive sham neurofeedback. Participants will be debriefed at the end of the study.

Device: Neurofeedback (from fMRI and/or EEG)

Interventions

Neurofeedback (from fMRI and/or EEG) DEVICE

During part of the task, a feedback display (e.g., thermometer stimulus) will be used to display the average brain activity for each participant. This signal will be acquired \~ every 1 second during the neurofeedback session and will dynamically update to reflect ongoing changes in brain activity. This continuously updated display is the primary feedback mechanism provided to the participant.

Noise Control; Reward-related Brain Region Feedback

Eligibility Criteria

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

You may qualify if:

• years of age
• Right handed
• In good general health
• Male or Female
• For ND individuals: Self-reported smoking ≥ 5 combustible cigarettes per day
• For ND individuals: Afternoon expired CO concentration of ≥ 8 ppm
• For ND individuals: Is willing and able to abstain from smoking for a few hours

You may not qualify if:

• History of chronic/significant medical condition
• Current or past 6 month use of prescription medications for psychiatric conditions (e.g., depression, anxiety)
• Current or past 6 month diagnosis of anxiety, bipolar disorder, depression, OCD, schizophrenia, psychosis, or personality disorder.
• Current substance abuse or dependence or history within the last 6 months (other than nicotine for ND individuals)
• For ND individuals: Positive drug test for anything other than marijuana
• For ND individuals: Currently on nicotine replacement therapy
• For ND individuals: Individuals who role their own cigarettes
• For ND individuals: Daily cannabis use
• For ND individuals: Consume more than 21 alcoholic drinks per week
• For ND individuals: Use harder drugs (e.g., cocaine, methamphetamine) more than 10 times per year
• For ND individuals: Currently taking medication that directly acts on the dopamine system (e.g., L-DOPA).
• Inability to understand written and/or spoken English language
• For MRI subjects: Claustrophobia or other contraindications to MRI scanning
• For MRI subjects: If female, pregnancy as determined by urine pregnancy test on the day of MRI scanning
• For MRI subjects: Presence of any metal in the body (e.g., implant, non-removable piercing, metal IUD)

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• Brain & Behavior Research Foundation: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Center for Cognitive Neuroscience

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: R. Alison Adcock, MD, PhD
• Organization: Duke University

alison.adcock@duke.edu

919-681-7486

Study Officials

• R. Alison Adcock, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: February 28, 2018
• Primary Completion: June 28, 2022
• Study Completion: July 5, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)