Trial Outcomes & Findings for Reduced Nicotine Cigarette Purchasing Decisions (NCT NCT04999644)

NCT ID: NCT04999644

Last Updated: 2024-02-09

Results Overview

Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome).

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: Four times over approximately two weeks
• Results posted on: 2024-02-09

Participant Flow

Participant milestones

Measure	Subjects Included in Analysis This study used a within subjects design (i.e., all subjects were to receive all conditions, full and reduced nicotine tobacco cigarette). Twenty-one subjects completed the study.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduced Nicotine Cigarette Purchasing Decisions

Baseline characteristics by cohort

Measure	Subjects Included in Analysis n=21 Participants This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study.
Age, Continuous	48.7 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Four times over approximately two weeks

Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome).

Outcome measures

Measure	Subjects Included in Analysis n=21 Participants This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study.
Demand Intensity Condition A: Told Full, Received Reduced	6.48 cigarettes Standard Error 4.55
Demand Intensity Condition B: Told Full, Received Full	8.10 cigarettes Standard Error 6.61
Demand Intensity Condition C: Told Reduced, Received Full	7.81 cigarettes Standard Error 5.63
Demand Intensity Condition D: Told Reduced, Received Reduced	6.48 cigarettes Standard Error 4.91

PRIMARY outcome

Timeframe: Four times over approximately two weeks

Population: Data are presented for all subjects with non-zero data

Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated)

Outcome measures

Measure	Subjects Included in Analysis n=21 Participants This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study.
Demand Elasticity Condition A: Told Full, Received Reduced	-1.31 log(cigarettes/dollar) Standard Deviation 1.08
Demand Elasticity Condition B: Told Full, Received Full	-1.45 log(cigarettes/dollar) Standard Deviation 0.50
Demand Elasticity Condition C: Told Reduced, Received Full	-1.57 log(cigarettes/dollar) Standard Deviation 0.60
Demand Elasticity Condition D: Told Reduced, Received Reduced	-1.26 log(cigarettes/dollar) Standard Deviation 1.17

SECONDARY outcome

Timeframe: Post-cigarette administration four times over approximately two weeks

A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome).

Outcome measures

Measure	Subjects Included in Analysis n=21 Participants This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study.
Minnesota Nicotine Withdrawal Scale Condition A: Told Full, Received Reduced	5.67 units on a scale Standard Deviation 6.95
Minnesota Nicotine Withdrawal Scale Condition B: Told Full, Received Full	5.14 units on a scale Standard Deviation 6.54
Minnesota Nicotine Withdrawal Scale Condition C: Told Reduced, Received Full	4.33 units on a scale Standard Deviation 4.95
Minnesota Nicotine Withdrawal Scale Condition D: Told Reduced, Received Reduced	6.24 units on a scale Standard Deviation 6.47

Adverse Events

Subjects Included in Analysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Justin Strickland

Johns Hopkins University School of Medicine

Phone: 4105501975

Email: jstric14@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place