Trial Outcomes & Findings for Addictive Potential of LCCs in Dual Users (NCT NCT03496077)

Last Updated: 2026-03-10

Results Overview

Hypothetical consumption of LCCs as prices increase. These are the model-adjusted predicted mean values of elasticity, adjusted for covariates. It is the expected change in consumption for a one unit change in price.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Post-treatment (after being assigned to use it for 7 days)

Results posted on

2026-03-10

Participant Flow

From August 2018-December 2020, we enrolled young adults, ages 18-34 years, who smoked both FCCs and cigarettes in central Connecticut using print and online media (e.g., Facebook, Craigslist), radio, and word-of-mouth.

Participant milestones

Participant milestones
Measure	Flavored LCCs First, Then Unflavored LCCs Half of the group will start with a flavored little cigar/cigarillo (LCC) and cross over to unflavored LCC. The LCCs will be a popular brand already available for sale on the market. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase	Unflavored LCCs First, Then Flavored LCCs Half of the group will start with an unflavored little cigar/cigarillo (LCC) and cross over to flavored LCC. The LCCs will be a popular brand already available for sale on the market. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase
Overall Study STARTED	30	35
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Addictive Potential of LCCs in Dual Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flavored LCCs First, Then Unflavored LCCs n=30 Participants Half of the group will start with a flavored little cigar/cigarillo (LCC) and cross over to unflavored LCC. The LCCs will be a popular brand already available for sale on the market. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase	Unflavored LCCs First, Then Flavored LCCs n=35 Participants Half of the group will start with an unflavored little cigar/cigarillo (LCC) and cross over to flavored LCC. The LCCs will be a popular brand already available for sale on the market. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase	Total n=65 Participants Total of all reporting groups
Age, Continuous	24.8 years STANDARD_DEVIATION 3.7 • n=68 Participants	24.6 years STANDARD_DEVIATION 4.9 • n=69 Participants	24.7 years STANDARD_DEVIATION 4.3 • n=137 Participants
Sex: Female, Male Female	5 Participants n=68 Participants	9 Participants n=69 Participants	14 Participants n=137 Participants
Sex: Female, Male Male	25 Participants n=68 Participants	26 Participants n=69 Participants	51 Participants n=137 Participants
Race/Ethnicity, Customized Non-Hispanic White	14 Participants n=68 Participants	13 Participants n=69 Participants	27 Participants n=137 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=68 Participants	10 Participants n=69 Participants	16 Participants n=137 Participants
Race/Ethnicity, Customized Non-Hispanic Black or African American	8 Participants n=68 Participants	6 Participants n=69 Participants	14 Participants n=137 Participants
Race/Ethnicity, Customized Other	2 Participants n=68 Participants	6 Participants n=69 Participants	8 Participants n=137 Participants
Heaviness of cigarette smoking in previous 30 days (# days smoked X mean per day)	171.9 days*mean cigarettes/day STANDARD_DEVIATION 292.0 • n=68 Participants	89.7 days*mean cigarettes/day STANDARD_DEVIATION 146.0 • n=69 Participants	127.6 days*mean cigarettes/day STANDARD_DEVIATION 227.3 • n=137 Participants
Heaviness of cigar smoking in previosu 30 days (# days smoked X mean per day)	67.5 days*avg cigars per day STANDARD_DEVIATION 88.5 • n=68 Participants	64.8 days*avg cigars per day STANDARD_DEVIATION 86.0 • n=69 Participants	66.1 days*avg cigars per day STANDARD_DEVIATION 86.5 • n=137 Participants
Smokes menthol cigarettes No	9 Participants n=68 Participants	12 Participants n=69 Participants	21 Participants n=137 Participants
Smokes menthol cigarettes Yes	21 Participants n=68 Participants	23 Participants n=69 Participants	44 Participants n=137 Participants
Smokes flavored cigars No	2 Participants n=68 Participants	9 Participants n=69 Participants	11 Participants n=137 Participants
Smokes flavored cigars Yes	28 Participants n=68 Participants	26 Participants n=69 Participants	54 Participants n=137 Participants
Annual household income <$10,000	10 Participants n=68 Participants	13 Participants n=69 Participants	23 Participants n=137 Participants
Annual household income $10,000-24,999	11 Participants n=68 Participants	9 Participants n=69 Participants	20 Participants n=137 Participants
Annual household income $25,000-49,999	6 Participants n=68 Participants	6 Participants n=69 Participants	12 Participants n=137 Participants
Annual household income $50,000 or more	3 Participants n=68 Participants	7 Participants n=69 Participants	10 Participants n=137 Participants
Highest educational attainment No high school degree, or high school/GED completed	15 Participants n=68 Participants	20 Participants n=69 Participants	35 Participants n=137 Participants
Highest educational attainment Greater than high school/GED	15 Participants n=68 Participants	15 Participants n=69 Participants	30 Participants n=137 Participants
Subjective financial situation Live comfortably	6 Participants n=68 Participants	5 Participants n=69 Participants	11 Participants n=137 Participants
Subjective financial situation Meet needs with a little left	12 Participants n=68 Participants	13 Participants n=69 Participants	25 Participants n=137 Participants
Subjective financial situation Just or don't meet basic needs	12 Participants n=68 Participants	17 Participants n=69 Participants	29 Participants n=137 Participants

PRIMARY outcome

Timeframe: Post-treatment (after being assigned to use it for 7 days)

Population: This was a within-subjects crossover study. N=47 participants were analyzed for this outcome, and all of them received the flavored cigarillo intervention and the unflavored cigarette intervention in random order. n=23 received flavored cigarillos first then unflavored cigarillos, and n=24 received unflavored cigarillos first then flavored cigarillos.

Outcome measures

Outcome measures
Measure	Flavored Cigarillos n=47 Participants Assigned to flavored cigarillos for 7-days	Unflavored Cigarillos n=47 Participants Assigned to unflavored cigarillos for 7-days
Demand Elasticity	0.027 cigarettes/dollar Interval 0.014 to 0.046	0.032 cigarettes/dollar Interval 0.017 to 0.054

PRIMARY outcome

Timeframe: Post-treatment (after 7 days of being assigned to condition)

Hypothetical consumption when free. These are the model-adjusted predicted mean values of intensity, adjusted for covariates.

Outcome measures

Outcome measures
Measure	Flavored Cigarillos n=47 Participants Assigned to flavored cigarillos for 7-days	Unflavored Cigarillos n=47 Participants Assigned to unflavored cigarillos for 7-days
Demand Intensity	4.193 mg of nicotine Interval 2.614 to 6.491	3.898 mg of nicotine Interval 2.421 to 5.947

Adverse Events

Flavored Cigarillos

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Unflavored Cigarillos

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flavored Cigarillos n=54 participants at risk Assigned to flavored cigarillos for 7-days	Unflavored Cigarillos n=53 participants at risk Assigned to unflavored cigarillos for 7-days
Respiratory, thoracic and mediastinal disorders Respiratory effects	1.9% 1/54 • Number of events 1 • About 3 weeks	11.3% 6/53 • Number of events 6 • About 3 weeks

Additional Information

Dr. Erin Mead-Morse

UConn Health

Phone: 860-679-8949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place