Trial Outcomes & Findings for Effects of Smoking Environments on Brain Reactivity (NCT NCT03421210)

Last Updated: 2021-01-19

Results Overview

Using fMRI the investigators examined brain function during cue-reactivity. During the scan, participants viewed pictures of personal and non-personal environments. Contrast of parameter estimate (COPE) values for the difference between personal smoking environment pictures and non-personal smoking environment pictures were extracted from anatomically defined brain regions using FSL's featquery for analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine Replacement Therapy Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Overall Study STARTED	88
Overall Study Received Functional Magnetic Resonance Imaging (fMRI)	42
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Smoking Environments on Brain Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine Replacement Therapy n=32 Participants Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Age, Continuous	39.8 years STANDARD_DEVIATION 11.59 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 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	15 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses.

Outcome measures

Outcome measures
Measure	Nicotine Replacement Therapy n=32 Participants Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures	0.0598 contrast of parameter estimate (COPE) Standard Deviation 0.09454

SECONDARY outcome

Timeframe: 2 weeks after quitting smoking

Population: All participants with post-quit EMA data.

EMA will be used to evaluate craving daily for 2 weeks after quitting. Subjects will rate their craving on a single item (How strong is your current urge to smoke?) using a scale from 1 "very slightly or not at all" to 5 "extremely".

Outcome measures

Outcome measures
Measure	Nicotine Replacement Therapy n=36 Participants Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire	2.49 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Weeks 1, 3, 6, and 10 weeks after quitting.

Population: 42 subjects entered the quit phase of the study.

Relapse defined as 7 consecutive days smoking at least 1 cigarette per day. Individuals lost to contact are presumed to have relapsed following their last visit.

Outcome measures

Outcome measures
Measure	Nicotine Replacement Therapy n=42 Participants Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Number of Participants Experiencing Relapse Week 1	16 Participants
Number of Participants Experiencing Relapse Week 3	9 Participants
Number of Participants Experiencing Relapse Week 6	3 Participants
Number of Participants Experiencing Relapse Week 10	0 Participants

Adverse Events

Nicotine Replacement Therapy

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotine Replacement Therapy n=42 participants at risk Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Nicotine patch: Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
Psychiatric disorders Vivid Dreams	11.9% 5/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Skin and subcutaneous tissue disorders Rash at Patch site	9.5% 4/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Skin and subcutaneous tissue disorders Itching/burning at patch site	19.0% 8/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Respiratory, thoracic and mediastinal disorders Coughing	11.9% 5/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Psychiatric disorders Irritability	19.0% 8/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Gastrointestinal disorders Heart Burn	4.8% 2/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Psychiatric disorders Nightmares	4.8% 2/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Psychiatric disorders Elevated CESD score	16.7% 7/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Nervous system disorders Headache	7.1% 3/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Psychiatric disorders Insomnia	7.1% 3/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
General disorders Hiccups	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Gastrointestinal disorders Diarrhea	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Respiratory, thoracic and mediastinal disorders Bronchitis	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Respiratory, thoracic and mediastinal disorders Nasal congestion/ sinusitis	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Vascular disorders Elevated Blood Pressure	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Vascular disorders Dizzyness upon standing	4.8% 2/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Vascular disorders Feeling Faint	4.8% 2/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Gastrointestinal disorders Nausea	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
General disorders Mouth/Throat Irritation	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
Vascular disorders Hand Numbness	2.4% 1/42 • 10 weeks after quitting smoking Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)

Additional Information

Anthony DeVito, MD

Duke University

Phone: 919-684-1377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place