Trial Outcomes & Findings for Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels (NCT NCT01588561)

NCT ID: NCT01588561

Last Updated: 2017-08-31

Results Overview

Peak nicotine level in each participant

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion

Results posted on

2017-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First, Then Nicotine Placebo first, then Intravenous Nicotine (1.5 mg/70 kg)	Nicotine First, Then Placebo Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo
Overall Study STARTED	14	1
Overall Study First Injection (Visit 1)	14	1
Overall Study Rest Period	14	1
Overall Study Second Injection (Visit 2)	14	1
Overall Study COMPLETED	14	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group.
Age, Continuous	26.5 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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	7 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Pack-years	11.2 pack-years STANDARD_DEVIATION 10.5 • n=5 Participants
Fagerström score	6.0 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: 0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion

Population: Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included.

Peak nicotine level in each participant

Outcome measures

Outcome measures
Measure	Nicotine n=14 Participants Intravenous Nicotine (1.5 mg/70 kg)	Placebo n=14 Participants Saline infusion
Peak Nicotine Levels	16.1 ng/ml Standard Deviation 8	0 ng/ml Standard Deviation 0

PRIMARY outcome

Timeframe: 40 minutes after infusion

Population: The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.

PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.

Outcome measures

Outcome measures
Measure	Nicotine n=12 Participants Intravenous Nicotine (1.5 mg/70 kg)	Placebo Saline infusion
Number of Brain Regions With a Change in Brain Activity Relative to Saline Increased BOLD Signal	9 brain regions	—
Number of Brain Regions With a Change in Brain Activity Relative to Saline Decreased BOLD Signal	5 brain regions	—

SECONDARY outcome

Timeframe: 40 minutes after infusion

PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years). The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.

Outcome measures

Outcome measures
Measure	Nicotine n=12 Participants Intravenous Nicotine (1.5 mg/70 kg)	Placebo Saline infusion
Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History Increased BOLD Signal	9 brain regions	—
Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History Decreased BOLD Signal	4 brain regions	—

SECONDARY outcome

Timeframe: 40 minutes after infusion

PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.

Outcome measures

Outcome measures
Measure	Nicotine n=12 Participants Intravenous Nicotine (1.5 mg/70 kg)	Placebo Saline infusion
Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine Increased BOLD Signal	9 brain regions	—
Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine Decreased BOLD Signal	7 brain regions	—

SECONDARY outcome

Timeframe: 30 minutes post-infusion

Population: One participant had incomplete serum nicotine results and was not included.

Final nicotine level in each participant

Outcome measures

Outcome measures
Measure	Nicotine n=14 Participants Intravenous Nicotine (1.5 mg/70 kg)	Placebo n=14 Participants Saline infusion
Final Nicotine Levels	8.2 ng/ml Standard Deviation 2.2	0 ng/ml Standard Deviation 0

Adverse Events

Nicotine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotine n=15 participants at risk Nicotine infusion	Saline n=15 participants at risk Saline infusion
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1	0.00% 0/15
General disorders Transient tightness in chest	6.7% 1/15 • Number of events 1	0.00% 0/15

Additional Information

Scott Lukas, Ph.D.

McLean Hospital

Phone: 617-855-2767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place