Trial Outcomes & Findings for Neural Basis of Eating Behavior in Abstinent Smokers (NCT NCT03438188)

Last Updated: 2025-02-05

Results Overview

The primary outcome measure is change in BOLD signal for the Food Cue-Induced Craving primary regions of interest for the BOLD fMRI analysis are anterior cingulate gyrus (ACC), Insula, Ventral Striatum (VS), and orbital frontal cortex (OFC). For the Working Memory N-Back Task the primary regions of interest for the BOLD analysis will be dorsal lateral prefrontal cortex (DLPFC) and posterior cingulate gyrus (PCC).

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

BOLD fMRI is collected on days 4 and 32 of protocol

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Smoking Then Abstinent Group The Smoking then Abstinent Group group will be scanned on 2 occasions:(1) after 4 days of smoking as usual, and (2) after a 4-day monitored practice quit attempt (biochemically verified).	Abstinent Then Smoking Group The Abstinent then Smoking Group group will be scanned on 2 occasions: (1) after a 4-day monitored practice quit attempt (biochemically verified), and (2) after 4 days of smoking as usual.	Non-Smoking Comparison Group Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.
Scan 1(Smoking, Abstinent or Non-smoker) STARTED	25	26	31
Scan 1(Smoking, Abstinent or Non-smoker) COMPLETED	17	18	27
Scan 1(Smoking, Abstinent or Non-smoker) NOT COMPLETED	8	8	4
Washout Period (Smoking or Abstinent) STARTED	17	18	0
Washout Period (Smoking or Abstinent) COMPLETED	14	14	0
Washout Period (Smoking or Abstinent) NOT COMPLETED	3	4	0
Scan 2 (Smoking or Abstinent) STARTED	14	14	0
Scan 2 (Smoking or Abstinent) COMPLETED	14	14	0
Scan 2 (Smoking or Abstinent) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Smoking Then Abstinent Group The Smoking then Abstinent Group group will be scanned on 2 occasions:(1) after 4 days of smoking as usual, and (2) after a 4-day monitored practice quit attempt (biochemically verified).	Abstinent Then Smoking Group The Abstinent then Smoking Group group will be scanned on 2 occasions: (1) after a 4-day monitored practice quit attempt (biochemically verified), and (2) after 4 days of smoking as usual.	Non-Smoking Comparison Group Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.
Scan 1(Smoking, Abstinent or Non-smoker) Withdrawal by Subject	1	1	1
Scan 1(Smoking, Abstinent or Non-smoker) Lost to Follow-up	4	3	2
Scan 1(Smoking, Abstinent or Non-smoker) change in eligibility	3	4	1
Washout Period (Smoking or Abstinent) Lost to Follow-up	0	2	0
Washout Period (Smoking or Abstinent) change in eligibility	3	2	0

Baseline Characteristics

Neural Basis of Eating Behavior in Abstinent Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smoking Then Abstinent Group n=25 Participants The Smoking then Abstinent Group group will be scanned on 2 occasions:(1) after 4 days of smoking as usual, and (2) after a 4-day monitored practice quit attempt (biochemically verified).	Abstinent Then Smoking Group n=26 Participants The Abstinent then Smoking Group group will be scanned on 2 occasions: (1) after a 4-day monitored practice quit attempt (biochemically verified), and (2) after 4 days of smoking as usual.	Non-Smoking Comparison Group n=31 Participants Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.	Total n=82 Participants Total of all reporting groups
Age, Continuous	51.38 years STANDARD_DEVIATION 14.31 • n=5 Participants	46.40 years STANDARD_DEVIATION 13.68 • n=7 Participants	39.65 years STANDARD_DEVIATION 14.86 • n=5 Participants	43.74 years STANDARD_DEVIATION 15.04 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	49 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: BOLD fMRI is collected on days 4 and 32 of protocol

Population: The smoking and abstinent fMRI session population is comprised of all smokers completing two fMRI sessions. The healthy comparison group is composed of all control group participants completing one fMRI scan.

Outcome measures

Outcome measures
Measure	Smoking fMRI Session n=28 Participants The Smoking scan on takes place after 4 days of smoking as usual.	Abstinent fMRI Session n=28 Participants The Abstinent scan takes place after a 4-day monitored practice quit attempt (biochemically verified).	Non-Smoking Comparison Group n=27 Participants Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (ACC)	0.000 percentage of signal change Standard Deviation 0.250	-0.014 percentage of signal change Standard Deviation 0.233	0.027 percentage of signal change Standard Deviation 0.215
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (Left Insula)	0.051 percentage of signal change Standard Deviation 0.252	-0.011 percentage of signal change Standard Deviation 0.254	0.055 percentage of signal change Standard Deviation 0.247
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (Right Insula)	0.057 percentage of signal change Standard Deviation 0.263	-0.013 percentage of signal change Standard Deviation 0.266	0.057 percentage of signal change Standard Deviation 0.246
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (Left VS)	-0.057 percentage of signal change Standard Deviation 0.359	0.062 percentage of signal change Standard Deviation .559	0.010 percentage of signal change Standard Deviation 0.497
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (Right VS)	-0.050 percentage of signal change Standard Deviation 0.330	0.053 percentage of signal change Standard Deviation 0.625	0.014 percentage of signal change Standard Deviation 0.368
Abstinence Induced Change in Task BOLD Signal Change Food Induced Craving (OFC)	0.015 percentage of signal change Standard Deviation 0.227	0.034 percentage of signal change Standard Deviation 0.338	0.104 percentage of signal change Standard Deviation 0.341
Abstinence Induced Change in Task BOLD Signal Change N-Back Task (left dorsal lateral prefrontal cortex)	0.211 percentage of signal change Standard Deviation 0.202	0.180 percentage of signal change Standard Deviation 0.237	0.211 percentage of signal change Standard Deviation 0.378
Abstinence Induced Change in Task BOLD Signal Change N-Back Task (right dorsal lateral prefrontal cortex)	0.231 percentage of signal change Standard Deviation 0.214	0.196 percentage of signal change Standard Deviation 0.239	0.243 percentage of signal change Standard Deviation 0.406
Abstinence Induced Change in Task BOLD Signal Change N-Back Task (posterior cingulate cortex)	-0.081 percentage of signal change Standard Deviation 0.202	-0.096 percentage of signal change Standard Deviation 0.215	-0.142 percentage of signal change Standard Deviation 0.273

Adverse Events

Smoking as Usual (4 Days)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Washout (2 Weeks)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Abstinent (4 Day Practice Quit Attempt)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Non-Smoking Comparison Session

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Smoking as Usual (4 Days) n=51 participants at risk The Smoking session takes place after 4 days of smoking as usual.	Washout (2 Weeks) n=31 participants at risk Washout occurs between scan 1 and scan 2 for the smoking group only.	Abstinent (4 Day Practice Quit Attempt) n=28 participants at risk The Abstinent session takes place after a 4-day monitored practice quit attempt (biochemically verified).	Non-Smoking Comparison Session n=31 participants at risk Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.
Nervous system disorders incidental finding	0.00% 0/51 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	3.6% 1/28 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.
General disorders fatigue	0.00% 0/51 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	3.6% 1/28 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.
General disorders Back Pain	2.0% 1/51 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/28 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.
Surgical and medical procedures tooth extraction	2.0% 1/51 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/28 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.
Injury, poisoning and procedural complications Swelling	2.0% 1/51 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/31 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	0.00% 0/28 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.	3.2% 1/31 • Number of events 1 • Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up). Adverse event reporting includes the total number of participants by intervention, whereas the Participant Flow module reports participants by order of administration of intervention. For total at-risk in adverse event tables, the participants for the two counterbalanced orders are summed (e.g. 25 (smoking then abstinent)+26 (abstinent then smoking) = 51 total) for a total at-risk by intervention.

Additional Information

James Loughead, Ph.D.

Perlman School of Medicine, University of Pennsylvania

Phone: 215-205-1876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place