Trial Outcomes & Findings for Acute and Chronic Nicotine Modulation of Reinforcement Learning (NCT NCT01830842)

Last Updated: 2017-12-19

Results Overview

The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging. Reward-cue related BOLD signal on an outcome expectation task.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety

Results posted on

2017-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine, Placebo Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration	Nicotine Withdrawal or Satiety Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence
Overall Study STARTED	30	24
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute and Chronic Nicotine Modulation of Reinforcement Learning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine, Placebo n=30 Participants Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration	Nicotine Withdrawal or Satiety n=24 Participants Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 11 • n=5 Participants	35 years STANDARD_DEVIATION 10 • n=7 Participants	34 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety

Population: Subjects who did not follow MRI task instructions, or those with \> 3 mm of movement, were excluded from the analyses.

Outcome measures

Outcome measures
Measure	Nonsmokers n=23 Participants Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration	Smokers n=21 Participants Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence
Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex Nicotine or satiety	7.3 percentage of BOLD signal Standard Deviation 15	6.3 percentage of BOLD signal Standard Deviation 12
Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex Placebo or abstinence	6.2 percentage of BOLD signal Standard Deviation 12	.02 percentage of BOLD signal Standard Deviation 8

Adverse Events

Nicotine, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine Withdrawal or Satiety

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

Merideth Addicott

University of Arkansas for Medical Sciences

Phone: 501-526-8436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place