NCT03438188: SIT

Neural Basis of Eating Behavior in Abstinent Smokers

Completed NA Results posted Last updated 5 February 2025

What this trial tests

NA trial testing Practice Quit Attempt in Nicotine Use Disorder in 82 participants. Completed in 30 August 2023.

Timeline

1 March 2018

Primary endpoint
1 April 2023

30 August 2023

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 March 2018
Primary completion	1 April 2023
Estimated completion	30 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Practice Quit Attempt

Conditions studied

• Nicotine Use Disorder — all drugs for Nicotine Use Disorder →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 45, any sex, with Nicotine Use Disorder. 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.

Abstinence Induced Change in Task BOLD Signal Change Primary · BOLD fMRI is collected on days 4 and 32 of protocol

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).

Food Induced Craving (ACC)

Group	Value	95% CI
Smoking fMRI Session	0.000	± 0.250
Abstinent fMRI Session	-0.014	± 0.233
Non-Smoking Comparison Group	0.027	± 0.215

Food Induced Craving (Left Insula)

Group	Value	95% CI
Smoking fMRI Session	0.051	± 0.252
Abstinent fMRI Session	-0.011	± 0.254
Non-Smoking Comparison Group	0.055	± 0.247

Food Induced Craving (Right Insula)

Group	Value	95% CI
Smoking fMRI Session	0.057	± 0.263
Abstinent fMRI Session	-0.013	± 0.266
Non-Smoking Comparison Group	0.057	± 0.246

Food Induced Craving (Left VS)

Group	Value	95% CI
Smoking fMRI Session	-0.057	± 0.359
Abstinent fMRI Session	0.062	± .559
Non-Smoking Comparison Group	0.010	± 0.497

Food Induced Craving (Right VS)

Group	Value	95% CI
Smoking fMRI Session	-0.050	± 0.330
Abstinent fMRI Session	0.053	± 0.625
Non-Smoking Comparison Group	0.014	± 0.368

Food Induced Craving (OFC)

Group	Value	95% CI
Smoking fMRI Session	0.015	± 0.227
Abstinent fMRI Session	0.034	± 0.338
Non-Smoking Comparison Group	0.104	± 0.341

N-Back Task (left dorsal lateral prefrontal cortex)

Group	Value	95% CI
Smoking fMRI Session	0.211	± 0.202
Abstinent fMRI Session	0.180	± 0.237
Non-Smoking Comparison Group	0.211	± 0.378

N-Back Task (right dorsal lateral prefrontal cortex)

Group	Value	95% CI
Smoking fMRI Session	0.231	± 0.214
Abstinent fMRI Session	0.196	± 0.239
Non-Smoking Comparison Group	0.243	± 0.406

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over 3 three-month period (2 months in person with 1-month phone follow-up).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Smoking as Usual (4 Days)

Serious: 0/51 (0%)

Deaths: 0/51

Washout (2 Weeks)

Serious: 0/31 (0%)

Deaths: 0/31

Abstinent (4 Day Practice Quit Attempt)

Serious: 0/28 (0%)

Deaths: 0/28

Non-Smoking Comparison Session

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (5 terms — click to expand)

Reaction	System	Smoking as Usual (4 Days)	Washout (2 Weeks)	Abstinent (4 Day Practice …	Non-Smoking Comparison Ses…
incidental finding	Nervous system disorders	—	—	—	—
fatigue	General disorders	—	—	—	—
Back Pain	General disorders	—	—	—	—
tooth extraction	Surgical and medical procedures	—	—	—	—
Swelling	Injury, poisoning and procedural complications	—	—	—	—

Data from ClinicalTrials.gov NCT03438188 adverse events section.

Sponsor's own description

The purpose of this research study is to better understand why people gain weight when they quit smoking by examining food intake and changes in brain activity in smokers when they are smoking as usual compared to when they have been deprived of cigarettes (i.e., have not smoked for 4 days) as compared to a non-smoker control group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial.
   Greene B, Bernardo L, Thompson M, Loughead J, et al · · 2023 · cited 4× · PMID 37477975 · DOI 10.2196/47121