NCT03612960

Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

Completed NA Results posted Last updated 20 August 2024

What this trial tests

NA trial testing Very low nicotine content cigarettes in Tobacco Dependence in 34 participants. Completed in 23 June 2023.

Timeline

20 February 2020

Primary endpoint
23 June 2023

23 June 2023

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	34
Start date	20 February 2020
Primary completion	23 June 2023
Estimated completion	23 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Very low nicotine content cigarettes — full drug profile →
• Normal nicotine content cigarettes — full drug profile →

Conditions studied

• Tobacco Dependence — all drugs for Tobacco Dependence →

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 21 to 60, any sex, with Tobacco Dependence. 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.

Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task Primary · Change in BOLD signal from baseline to the 6-week visit.

Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.

Group	Value	95% CI
Very Low Nicotine Content Cigarettes	0.13	± 0.18
Normal Nicotine Content Cigarettes	-0.16	± 0.18

Change in Self-reported Cigarettes Per Day Secondary · Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.

Difference in week 6 mean minus week 1 mean of cigarettes used per day reported by participants on daily logs.

Group	Value	95% CI
Very Low Nicotine Content Cigarettes	-5.1	± 7.9
Normal Nicotine Content Cigarettes	3.3	± 16.0

Change in Percentage of Immediate Choices on Monetary Delay Discounting Task Secondary · Changes from baseline to 6-weeks post intervention.

A difference score (6-weeks minus baseline) of the percentage of trials where the immediate (vs. delayed) monetary option was chosen out of all task trials during the monetary delay discounting task that was completed outside of the MRI scan.

Group	Value	95% CI
Very Low Nicotine Content Cigarettes	0.20	± 30.26
Normal Nicotine Content Cigarettes	1.57	± 9.16

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years, 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Very Low Nicotine Content Cigarettes

Serious: 0/21 (0%)

Deaths: 0/21

Normal Nicotine Content Cigarettes

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (2 terms — click to expand)

Reaction	System	Very Low Nicotine Content …	Normal Nicotine Content Ci…
Fractured Finger	Musculoskeletal and connective tissue disorders	—	—
Nausea and Headaches	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03612960 adverse events section.

Sponsor's own description

The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.