Trial Outcomes & Findings for Neural Mechanisms Associated With Risk of Smoking Relapse (NCT NCT02837510)

Last Updated: 2025-03-05

Results Overview

The primary outcome will be the number of days to relapse following the target quit date. Relapse will be confirmed using a conventional SRNT guideline criterion of either a positive biochemical verification of smoking or 7 consecutive days of smoking based on self-report (it is very unlikely that a subject would meet the latter criterion without also meeting the former, given the long half-life of cotinine). The days to relapse will be based upon time from target quit date to the first day of the relapse period. Self-reported daily smoking data will be collected using a validated timeline follow-back method. Self-reported abstinence will be biochemically verified on a weekly basis using urine cotinine (\<100ng/ml) and a CO reading of ≤5PPM. Drop-outs will be considered relapsers following the last date of abstinence data provided.

Recruitment status

COMPLETED

Study phase

Target enrollment

119 participants

Primary outcome timeframe

6 months after target quit date

Results posted on

2025-03-05

Participant Flow

After study intake participants were randomized to one of two scan order: Abstinent then Smoking, Smoking then Abstinent.

Participant milestones

Participant milestones
Measure	Abstinent Then Smoking This group received abstinent session first in counterbalanced order.	Smoking Then Abstinent This group received smoking session first in counterbalanced order.
1st Pretreatment fMRI Session STARTED	61	58
1st Pretreatment fMRI Session COMPLETED	60	57
1st Pretreatment fMRI Session NOT COMPLETED	1	1
Washout (2 Weeks) STARTED	60	57
Washout (2 Weeks) COMPLETED	59	56
Washout (2 Weeks) NOT COMPLETED	1	1
2nd Pretreatment fMRI Session STARTED	59	56
2nd Pretreatment fMRI Session COMPLETED	58	55
2nd Pretreatment fMRI Session NOT COMPLETED	1	1
Quit Attempt (6 Months) STARTED	58	55
Quit Attempt (6 Months) COMPLETED	56	53
Quit Attempt (6 Months) NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Abstinent Then Smoking This group received abstinent session first in counterbalanced order.	Smoking Then Abstinent This group received smoking session first in counterbalanced order.
1st Pretreatment fMRI Session Lost to Follow-up	1	1
Washout (2 Weeks) Adverse Event	0	1
Washout (2 Weeks) Lost to Follow-up	1	0
2nd Pretreatment fMRI Session Adverse Event	1	0
2nd Pretreatment fMRI Session Lost to Follow-up	0	1
Quit Attempt (6 Months) Adverse Event	2	2

Baseline Characteristics

Neural Mechanisms Associated With Risk of Smoking Relapse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Smoking Cessation Counseling n=119 Participants Participants will receive a standard treatment program consisting of smoking cessation counseling. Standard smoking cessation counseling: Participants will discuss reasons for quitting, the model of smoking as a learned habit, triggers for smoking, and trigger management; receive brief training in how to manage withdrawal symptoms and relapse prevention counseling and receive the NCI Clearing the Air self-help smoking cessation booklet. The target quit date (TQD) session will be scheduled to occur up to 2 weeks following the pre-quit session. Participants will then meet with a smoking cessation counselor for a 15 minute booster counseling session. During the first week following TQD there will be two monitoring visits to closely monitor abstinence. Weekly thereafter for four weeks, participants will attend a brief booster counseling session.
Age, Continuous	44.6 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	72 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants
Fagerstrom Test For Nicotine Dependence	4.72 units on a scale STANDARD_DEVIATION 1.79 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months after target quit date

Population: Participants completing both fMRI sessions (smoking, abstinent) and starting the quit period were included in the analysis.

Outcome measures

Outcome measures
Measure	Abstinent Then Smoking n=58 Participants This group received abstinent session first in counterbalanced order.	Smoking Then Abstinent n=55 Participants This group received smoking session first in counterbalanced order.
Days to Relapse	3.95 days Standard Deviation 2.67	3.78 days Standard Deviation 2.69

SECONDARY outcome

Timeframe: 24 hours

Population: Participants completing both fMRI sessions (smoking, abstinent) were included in the analysis.

To measure the effects of acute 24-hour abstinence from smoking on executive function, functional magnetic resonance imaging (fMRI) was utilized to assess the relative importance of dorsolateral prefrontal cortex (left DLPFC, right DLPFC), Medial Frontal/Cingulate Gyrus (MF/CG), Posterior Cingulate Cortex (PCC) and Prefrontal cortex (PFC) blood oxygen dependent (BOLD) signals during working memory task performance. Measurement of BOLD percent signal change range is 0 to 2%. Percent signal change is the difference in fMRI signal between the baseline condition (B) and the task condition (T) and calculated here as: percent signal change = (T-B)/B×100%. Greater percent signal change in the DLPFC, MF/CG, PCC, and PFC is generally associated with better executive function.

Outcome measures

Outcome measures
Measure	Abstinent Then Smoking n=115 Participants This group received abstinent session first in counterbalanced order.	Smoking Then Abstinent n=115 Participants This group received smoking session first in counterbalanced order.
Brain Activation (BOLD Percent Signal Change) Left DLPFC	0.23 percentage of signal change Standard Deviation 0.349	0.26 percentage of signal change Standard Deviation 0.268
Brain Activation (BOLD Percent Signal Change) RIght DLPFC	0.22 percentage of signal change Standard Deviation .331	0.23 percentage of signal change Standard Deviation 0.240
Brain Activation (BOLD Percent Signal Change) MF/CG	0.21 percentage of signal change Standard Deviation 0.307	0.24 percentage of signal change Standard Deviation 0.239
Brain Activation (BOLD Percent Signal Change) PCC	-0.25 percentage of signal change Standard Deviation 0.306	-0.34 percentage of signal change Standard Deviation 0.239
Brain Activation (BOLD Percent Signal Change) PFC	-0.31 percentage of signal change Standard Deviation 0.491	-0.37 percentage of signal change Standard Deviation 0.389

Adverse Events

Pre-treatment fMRI Abstinent Session

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Washout (2 Weeks)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pre-treatment fMRI Smoking Session

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Quit Attempt (6 Months)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-treatment fMRI Abstinent Session n=117 participants at risk Reporting AEs experienced for all participants during the Abstinent session. This session was conducted following a 24 hr period of abstinence from smoking.	Washout (2 Weeks) n=117 participants at risk A two-week washout period (smoking as usual) separated scan 1 and scan 2.	Pre-treatment fMRI Smoking Session n=115 participants at risk Reporting AEs experienced for all participants during the smoking session. This session was conducted following a 24 hr period of smoking as usual.	Quit Attempt (6 Months) n=113 participants at risk Following the completion of the pretreatment fMRI session, participants set a target quit date, received smoking cessation counseling, and were monitored for six months.
Psychiatric disorders Hospitalization	0.00% 0/117 • 1 year	0.00% 0/117 • 1 year	0.00% 0/115 • 1 year	0.88% 1/113 • Number of events 1 • 1 year
General disorders Hypoglycemic event	0.00% 0/117 • 1 year	0.00% 0/117 • 1 year	0.00% 0/115 • 1 year	0.88% 1/113 • Number of events 1 • 1 year
Surgical and medical procedures hospitalization	0.00% 0/117 • 1 year	0.00% 0/117 • 1 year	0.00% 0/115 • 1 year	0.88% 1/113 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders hospitalization	0.00% 0/117 • 1 year	0.00% 0/117 • 1 year	0.00% 0/115 • 1 year	0.88% 1/113 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Pre-treatment fMRI Abstinent Session n=117 participants at risk Reporting AEs experienced for all participants during the Abstinent session. This session was conducted following a 24 hr period of abstinence from smoking.	Washout (2 Weeks) n=117 participants at risk A two-week washout period (smoking as usual) separated scan 1 and scan 2.	Pre-treatment fMRI Smoking Session n=115 participants at risk Reporting AEs experienced for all participants during the smoking session. This session was conducted following a 24 hr period of smoking as usual.	Quit Attempt (6 Months) n=113 participants at risk Following the completion of the pretreatment fMRI session, participants set a target quit date, received smoking cessation counseling, and were monitored for six months.
General disorders vertigo	0.00% 0/117 • 1 year	0.85% 1/117 • Number of events 1 • 1 year	0.00% 0/115 • 1 year	0.00% 0/113 • 1 year
General disorders Accident	0.00% 0/117 • 1 year	0.00% 0/117 • 1 year	0.87% 1/115 • Number of events 1 • 1 year	0.00% 0/113 • 1 year

Additional Information

James Loughead PhD

University of Pennsylvaina

Phone: 215-746-6827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place