Trial Outcomes & Findings for Nicotine Receptor Levels and Smoking Cessation (NCT NCT01788943)

NCT ID: NCT01788943

Last Updated: 2018-03-12

Results Overview

Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.

• Recruitment status: COMPLETED
• Target enrollment: 24 participants
• Primary outcome timeframe: following overnight nicotine abstinence
• Results posted on: 2018-03-12

Participant Flow

10/01/2012-03/28/2014 recruitment at the Center for Interdisciplinary Research on Nicotine Addiction at the University of Pennsylvania

Participant milestones

Measure	Slow Metabolizers. Participants with an NMR \< 0.26 will be considered slow metabolizers.	Normal Metabolizers Participants with an NMR \>= 0.26 will be considered normal metabolizers.
Overall Study STARTED	13	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Slow Metabolizers. Participants with an NMR \< 0.26 will be considered slow metabolizers.	Normal Metabolizers Participants with an NMR \>= 0.26 will be considered normal metabolizers.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Nicotine Receptor Levels and Smoking Cessation

Baseline characteristics by cohort

Measure	Normal Nicotine Metabolizers n=12 Participants Nicotine Metabolite Radio of \> or = 0.26	Slow Nicotine Metabolizers n=12 Participants Nicotine Metabolite Radio of \< 0.26.	Total n=24 Participants Total of all reporting groups
Age, Continuous	48.7 years n=5 Participants	45.5 years n=7 Participants	47.1 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: following overnight nicotine abstinence

Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.

Outcome measures

Measure	Slow Metabolizers. n=12 Participants Subjects with an NMR \< 0.26.	Normal Metabolizers n=12 Participants Subjects with an NMR of \> or = 0.26.
Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.	17.5 Distribution Volume Ratio (Vt/fp) Standard Deviation 2.4	26.8 Distribution Volume Ratio (Vt/fp) Standard Deviation 3.1

SECONDARY outcome

Timeframe: Before and immediately following the PET scan.

Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70.

Outcome measures

Measure	Slow Metabolizers. n=12 Participants Subjects with an NMR \< 0.26.	Normal Metabolizers n=12 Participants Subjects with an NMR of \> or = 0.26.
Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.	-8.1 units on a scale Standard Deviation 10.1	1.8 units on a scale Standard Deviation 7.7

Adverse Events

Slow Metabolizers (NMR < 0.26)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Metabolizers (NMR > or + 0.26)

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

Jacob Dubroff,M.D., Ph.D., Assistant Professor of Radiology

University of Pennsylvania

Phone: 215-662-3041

Email: jacob.dubroff@uphs.upenn.edu

Results disclosure agreements

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