Trial Outcomes & Findings for Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol (NCT NCT03580525)

Last Updated: 2024-03-12

Results Overview

The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

24 participants

Primary outcome timeframe

up to 10 minutes

Results posted on

2024-03-12

Participant Flow

24 subjects were randomized, yet two subjects didn't complete all five days. Therefore, some conditions have 23 participants, and some have 22.

Participant milestones

Participant milestones
Measure	Randomized Participants Each participant was randomized to each condition, the order and number of groups presents difficulty in the breakdown, so the number that experienced each level of the intervention is reported.
Overall Study STARTED	23
Overall Study Nicotine Saline Infusion 0.00mcg/kg/s	22
Overall Study Nicotine Infusion 0.24mcg/kg/s	23
Overall Study Nicotine Infusion 0.096mcg/kg/s	23
Overall Study Nicotine Infusion 0.048mcg/kg/s	22
Overall Study Nicotine Infusion 0.024mcg/kg/s	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two females only completed certain days not true completers but were added to the analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Baseline Characteristics n=24 Participants Baseline characteristics of all participants prior to randomization.
Age, Continuous	28.1 years STANDARD_DEVIATION 3.4 • n=39 Participants • Two females only completed certain days not true completers but were added to the analysis
Sex: Female, Male Female	11 Participants n=39 Participants
Sex: Female, Male Male	13 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race/Ethnicity, Customized Black	14 Participants n=39 Participants
Race/Ethnicity, Customized White	7 Participants n=39 Participants
Race/Ethnicity, Customized Native American	1 Participants n=39 Participants
Race/Ethnicity, Customized Other	2 Participants n=39 Participants

PRIMARY outcome

Timeframe: up to 10 minutes

Population: Intention to treat analysis.

Outcome measures

Outcome measures
Measure	Randomized Participants n=23 Participants Each participant received each level of the intervention in a random order.
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects nicotine saline infusion 0.00mcg/kg/s	7.03 score on a scale Standard Error 5.34
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects nicotine infusion 0.24mcg/kg/s	37.48 score on a scale Standard Error 5.14
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects nicotine infusion 0.096mcg/kg/s	41.91 score on a scale Standard Error 5.15
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects nicotine infusion 0.048mcg/kg/s	28.22 score on a scale Standard Error 5.22
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects nicotine infusion 0.024mcg/kg/s	22.12 score on a scale Standard Error 5.05

PRIMARY outcome

Timeframe: up to 10 minutes post infusion

Population: Intention to treat analysis.

The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.