Trial Outcomes & Findings for Self-activation in Individuals With and Without Nicotine Dependence (NCT NCT03170258)

Last Updated: 2024-09-05

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

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

Results posted on

2024-09-05

Participant Flow

Participants were recruited from the Duke University community and surrounding Durham area via flyers, print advertisements, online advertisements, and word of mouth. To qualify for the study, subjects who smoke must self-report smoking greater than or equal to 5 cigarettes per day and be in good health.

No participants were randomized to the Noise Control arm.

Participant milestones

Participant milestones
Measure	Reward-related Brain Region Feedback 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. Neurofeedback (from fMRI and/or EEG): 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 Participants in this group will receive sham neurofeedback. Participants will be debriefed at the end of the study. Neurofeedback (from fMRI and/or EEG): 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.
Overall Study STARTED	46	0
Overall Study COMPLETED	39	0
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Reward-related Brain Region Feedback 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. Neurofeedback (from fMRI and/or EEG): 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 Participants in this group will receive sham neurofeedback. Participants will be debriefed at the end of the study. Neurofeedback (from fMRI and/or EEG): 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.
Overall Study Physician Decision	4	0
Overall Study Equipment issues	1	0
Overall Study Medication	1	0
Overall Study Sleep issues	1	0

Baseline Characteristics

Self-activation in Individuals With and Without Nicotine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reward-related Brain Region Feedback n=46 Participants 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. Neurofeedback (from fMRI and/or EEG): 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.
Age, Continuous	29.5 years STANDARD_DEVIATION 9.86 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants

PRIMARY outcome

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

Population: Of the total number of completed participants (n=39), 5 participants completed data collection for the fMRI portion.

Outcome measures

Outcome measures
Measure	Reward-related Brain Region Feedback n=5 Participants 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. Neurofeedback (from fMRI and/or EEG): 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.
Percent Change in Reward-related Brain Activation as Measured by fMRI	0.4864 percentage of signal change Standard Deviation 0.4798

PRIMARY outcome

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

Population: Of the total number of completed participants (n=39), 34 total participants completed data collection for the EEG portion; 6 participants included in analysis due to data quality.

Outcome measures

Outcome measures
Measure	Reward-related Brain Region Feedback n=6 Participants 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. Neurofeedback (from fMRI and/or EEG): 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.
Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power	0.13 ratio of Beta to Theta power Standard Deviation 0.12

SECONDARY outcome

Timeframe: Collected once during the screening visit

Population: Saliva samples not collected due to safety procedure during COVID-19 pandemic.

Dopamine availability as assessed by genetic saliva samples

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 30 minutes following the neurofeedback session

Population: Participants who chose to smoke a cigarette after the MRI session.

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

Outcome measures

Outcome measures
Measure	Reward-related Brain Region Feedback n=2 Participants 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. Neurofeedback (from fMRI and/or EEG): 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.
Onset to Smoking a Cigarette	1.00 minutes Standard Deviation 1.41

Adverse Events

Reward-related Brain Region Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

R. Alison Adcock, MD, PhD

Duke University

Phone: 919-681-7486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place