Trial Outcomes & Findings for Nicotine Reinforcement and Aversion in Young Adult Light Smokers (NCT NCT01495819)

Last Updated: 2021-08-31

Results Overview

The Drug Effects Questionnaire (DEQ) ratings subscale that measures the pleasurable effects was used. I The minimum score is zero with the maximum score of a 100millimeters. The higher the score means the more pleasurable.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Up to 10 Minutes

Results posted on

2021-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Study Participants subjects will be randomly assigned to one of the five doses of nicotine (0.0125, 0.025, 0.0.5, 0.1 and 0.2 mg/70 kg or about 0.18, 0.36, 0.7, 1.4 and 2.8 µg/kg). At the beginning of each experimental session, subjects will first sample the assigned nicotine dose and placebo (saline) condition that are randomly labeled as A or B. which may be nicotine or saline. This procedure will allow subjects to sample the nicotine and saline that will be available during that session. In addition, subjective and physiological responses to the sample nicotine dose and saline will be assessed.
Overall Study STARTED	34
Overall Study Nicotine 0.0125	31
Overall Study Nicotine 0.025	32
Overall Study Nicotine 0.05	33
Overall Study Nicotine 0.1	31
Overall Study NIcotine 0.2	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Reinforcement and Aversion in Young Adult Light Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Participants n=34 Participants In this crossover study, all participants received all 5 treatments, including placebo.
Age, Continuous	26.7 years STANDARD_DEVIATION 3.1 • n=93 Participants
Sex: Female, Male Female	11 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	26 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Region of Enrollment United States	34 participants n=93 Participants
FTND	1.6 units on a scale STANDARD_DEVIATION 1.3 • n=93 Participants
Average cigarettes per day	4.5 cigarettes per day STANDARD_DEVIATION 1.1 • n=93 Participants
Years of smoking	8.7 years STANDARD_DEVIATION 4.4 • n=93 Participants
Serum cotinine level	137.4 ng/mL STANDARD_DEVIATION 104.0 • n=93 Participants

PRIMARY outcome

Timeframe: Up to 10 Minutes

Population: Thirty four subject were randomized, 4 didn't complete all five test sessions, the sessions that were completed were analyzed.

Outcome measures

Outcome measures
Measure	Study Participants n=34 Participants In this crossover study, all participants received all 5 treatments, including placebo.
DEQ - Pleasurable Placebo	2.14 score on a scale Standard Error 0.20
DEQ - Pleasurable 0.0125	2.05 score on a scale Standard Error 0.26
DEQ - Pleasurable 0.025	1.98 score on a scale Standard Error 0.26
DEQ - Pleasurable 0.05	2.37 score on a scale Standard Error 0.25
DEQ - Pleasurable 0.1	2.67 score on a scale Standard Error 0.26
DEQ - Pleasurable 0.2	3.24 score on a scale Standard Error 0.26

PRIMARY outcome

Timeframe: Up to 10 Minutes

Population: Thirty four subject were randomized, 4 didn't complete all five test sessions, the sessions that were completed were analyzed.

The DEQ is measured using millimeters. The minimum score is zero with the maximum score of a 100millimeters. rug Effects Questionnaire (DEQ) ratings subscale that measures the aversive effects was used. The higher the score means more aversive.

Outcome measures

Outcome measures
Measure	Study Participants n=34 Participants In this crossover study, all participants received all 5 treatments, including placebo.
DEQ - Aversive Placebo	1.30 score on a scale Standard Error 0.20
DEQ - Aversive 0.0125	1.26 score on a scale Standard Error 0.22
DEQ - Aversive 0.025	1.50 score on a scale Standard Error 0.22
DEQ - Aversive 0.05	1.21 score on a scale Standard Error 0.22
DEQ - Aversive 0.1	1.22 score on a scale Standard Error 0.22
DEQ - Aversive 0.2	1.37 score on a scale Standard Error 0.22

PRIMARY outcome

Timeframe: Up to10 Minutes

Population: Thirty four subject were randomized, 4 didn't complete all five test sessions, the sessions that were completed were analyzed.

The Drug Effects Questionnaire (DEQ) ratings subscale that measures the stimulatory effects was used. DEQ is measured using millimeters. The minimum score is zero with the maximum score of a 100millimeters. The higher the score means more stimulation.