Trial · NCT01928758

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

NCT01928758, Not applicable, Completed, Milton S. Hershey Medical Center; results first posted 2019-02-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders. Trials, record NCT01928758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928758

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
NCT number: NCT01928758
Status: Completed
Phases: Not applicable
Enrollment: 245 participants, actual
Lead sponsor: Milton S. Hershey Medical Center
Conditions: Tobacco Dependence
Interventions: Reduced Nicotine Content Cigarettes, Usual Nicotine Content Cigarettes
First posted: 2013-08-27
Last updated: 2019-06-28
Results first posted: 2019-02-08
Limitations and caveats: The sample size was not reached due to a shortage of study cigarette inventory.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Plasma Cotinine Concentration	Measured at the end of the last 3 weeks of randomization trial phase	Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.
Secondary	Quick Inventory of Depressive Symptomatology	Measured at the end of the last 3 weeks of randomization trial phase	A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.
Secondary	Perceived Stress Scale	Measured at the end of the last 3 weeks of randomization trial phase	10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.
Secondary	Minnesota Nicotine Withdrawal Scale	Measured at the end of the last 3 weeks of randomization trial phase	This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.
Other	Intention to Quit Smoking	At end of 18-week randomized trial phase	Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking
Other	Abstinence From Smoking	Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).	Smokers assigned to reduced nicotine content cigarettes will be more likely to successfully abstain from smoking at the end of the trial, based on all randomized participants, defined as no cigarette use in past 7 days, verified by exhaled carbon monoxide \<10ppm.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Plasma Cotinine Concentration	Measured at the end of the last 3 weeks of randomization trial phase	Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).	ng/mL	MEAN
SECONDARY	Quick Inventory of Depressive Symptomatology	Measured at the end of the last 3 weeks of randomization trial phase	Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).	score on a scale	MEAN
SECONDARY	Perceived Stress Scale	Measured at the end of the last 3 weeks of randomization trial phase	Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).	score on a scale	MEAN
SECONDARY	Minnesota Nicotine Withdrawal Scale	Measured at the end of the last 3 weeks of randomization trial phase	Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Intention to Quit Smoking	At end of 18-week randomized trial phase	Participants who attended the visit at the end of the 18-week randomized trial phase	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Abstinence From Smoking	Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).	All randomized participants	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Plasma Cotinine Concentration	Reduced Nicotine Content Cigarettes	82.8	Standard Deviation 154.3	ng/mL
Plasma Cotinine Concentration	Usual Nicotine Content Cigarettes	259.0	Standard Deviation 151.3	ng/mL
Quick Inventory of Depressive Symptomatology	Reduced Nicotine Content Cigarettes	5.5	Standard Deviation 4.3	score on a scale
Quick Inventory of Depressive Symptomatology	Usual Nicotine Content Cigarettes	5.3	Standard Deviation 3.9	score on a scale
Perceived Stress Scale	Reduced Nicotine Content Cigarettes	15.0	Standard Deviation 7.6	score on a scale
Perceived Stress Scale	Usual Nicotine Content Cigarettes	15.1	Standard Deviation 7.8	score on a scale
Minnesota Nicotine Withdrawal Scale	Reduced Nicotine Content Cigarettes	8.1	Standard Deviation 6.8	score on a scale
Minnesota Nicotine Withdrawal Scale	Usual Nicotine Content Cigarettes	9.0	Standard Deviation 5.9	score on a scale
Intention to Quit Smoking	Reduced Nicotine Content Cigarettes	33		Participants
Intention to Quit Smoking	Usual Nicotine Content Cigarettes	25		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Reduced Nicotine Content Cigarettes	94
Overall Study	STARTED	Usual Nicotine Content Cigarettes	94
Overall Study	COMPLETED	Reduced Nicotine Content Cigarettes	69
Overall Study	COMPLETED	Usual Nicotine Content Cigarettes	74
Overall Study	NOT COMPLETED	Reduced Nicotine Content Cigarettes	25
Overall Study	NOT COMPLETED	Usual Nicotine Content Cigarettes	20

Source ClinicalTrials.gov

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Reduced Nicotine Content Cigarettes	6	94	6
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Usual Nicotine Content Cigarettes	3	94	3
other	Anxiety	Psychiatric disorders	Reduced Nicotine Content Cigarettes	22	94	28
other	Anxiety	Psychiatric disorders	Usual Nicotine Content Cigarettes	19	94	22
other	Back pain	Musculoskeletal and connective tissue disorders	Reduced Nicotine Content Cigarettes	3	94	4
other	Back pain	Musculoskeletal and connective tissue disorders	Usual Nicotine Content Cigarettes	6	94	6
other	Cough	Respiratory, thoracic and mediastinal disorders	Reduced Nicotine Content Cigarettes	5	94	5
other	Cough	Respiratory, thoracic and mediastinal disorders	Usual Nicotine Content Cigarettes	5	94	5
other	Depression	Psychiatric disorders	Reduced Nicotine Content Cigarettes	30	94	39
other	Depression	Psychiatric disorders	Usual Nicotine Content Cigarettes	21	94	26

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Reduced Nicotine Content Cigarettes	0	94
Total, all-cause mortality	Usual Nicotine Content Cigarettes	0	94
Total, other adverse events	Reduced Nicotine Content Cigarettes	70	94
Total, other adverse events	Usual Nicotine Content Cigarettes	72	94
Total, serious adverse events	Reduced Nicotine Content Cigarettes	7	94
Total, serious adverse events	Usual Nicotine Content Cigarettes	10	94

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28103841	BACKGROUND	PubMed
36322562	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50DA036107	Pennsylvania State University Tobacco Center of Regulatory Science (TCORS)	MUSCAT, JOSHUA E; FOULDS, JONATHAN	PENNSYLVANIA STATE UNIV HERSHEY MED CTR	NATIONAL INSTITUTE ON DRUG ABUSE	2013 to 2018

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: Intention to Quit Smoking	Trial comparisons
Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: Abstinence From Smoking	Trial comparisons
Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: deaths from any cause	Trial comparisons
Reduced Nicotine Content Cigarettes vs Usual Nicotine Content Cigarettes: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01928758

GET https://conductscience.org/api/trials/v1/NCT01928758/events?page=2

API reference For AI assistants