NCT02927847

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Completed Phase 1, PHASE2 Results posted Last updated 28 June 2022

What this trial tests

Phase 1, PHASE2 trial testing Nicotine Patch in Smoking in 35 participants. Completed in 27 May 2022.

Timeline

1 February 2017

Primary endpoint
28 May 2021

27 May 2022

Quick facts

Lead sponsor	Maggie M Sweitzer, PhD
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	35
Start date	1 February 2017
Primary completion	28 May 2021
Estimated completion	27 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Nicotine Patch (nicotine-patch) — full drug profile →
• SPECTRUM Nicotine Research Cigarettes (.03 mg) — full drug profile →
• Behavioral Activation
• Supportive Counseling

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

Maggie M Sweitzer, PhD — full company profile →

Who can join

Adults 18 to 55, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward Primary · baseline, week 5

Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.

Group	Value	95% CI
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)	-0.085	± 0.21
VLNC (Very Low Nicotine Cigarettes) Only	-0.067	± 0.36

Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward Primary · baseline, week 5

Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking reward anticipation. BOLD signal change is estimated from the contrast of smoking reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.

Group	Value	95% CI
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)	0.011	± 0.157
VLNC (Very Low Nicotine Cigarettes) Only	-0.036	± 0.226

Number of Participants Who Relapsed or Are Presumed to Have Relapsed Primary · weeks 6 to 13

Relapse is defined as return to 7 consecutive days of smoking.

Group	Value	95% CI
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)	9
VLNC (Very Low Nicotine Cigarettes) Only	9

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 1 to week 13. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)

Serious: 0/16 (0%)

Deaths: 0/16

VLNC (Very Low Nicotine Cigarettes) Only

Serious: 0/19 (0%)

Deaths: 0/19

Other adverse events (38 terms — click to expand)

Reaction	System	BA (Behavioral Activation)…	VLNC (Very Low Nicotine Ci…
Irritability	Psychiatric disorders	—	—
Itchiness at patch site	Skin and subcutaneous tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Mouth/throat irritaiton	Respiratory, thoracic and mediastinal disorders	—	—
Vivid or abnormal dreams	General disorders	—	—
Cold/upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—	—
Stomach bug	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Insomnia	General disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Runny nose/congestion	Respiratory, thoracic and mediastinal disorders	—	—
Heart burn	Gastrointestinal disorders	—	—
Arthritis/joint pain	Musculoskeletal and connective tissue disorders	—	—
Stress	Social circumstances	—	—
Allergies/hay fever	Immune system disorders	—	—
Cut finger/hand	Injury, poisoning and procedural complications	—	—
Fever	Infections and infestations	—	—
Increased phlegm	Respiratory, thoracic and mediastinal disorders	—	—
Loss of voice	Respiratory, thoracic and mediastinal disorders	—	—
Hunger	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Upset stomach/nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Phantom Limb	Nervous system disorders	—	—
Heat sensitivity in extremeties	Nervous system disorders	—	—
Tightness in lower back	Musculoskeletal and connective tissue disorders	—	—
Hip pain	Musculoskeletal and connective tissue disorders	—	—
Muscle spasm	Musculoskeletal and connective tissue disorders	—	—
Sleep issues	General disorders	—	—
Sedation	General disorders	—	—
Nicotine withdrawal	General disorders	—	—
Jitteriness	Psychiatric disorders	—	—
Sadness	Psychiatric disorders	—	—
Suicidal ideation	Psychiatric disorders	—	—
Food allergy	Immune system disorders	—	—
Car accident	Injury, poisoning and procedural complications	—	—
Poison ivy	Injury, poisoning and procedural complications	—	—
Root canal	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT02927847 adverse events section.

Sponsor's own description

The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes. The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Associations between compliance with very low nicotine content (VLNC) cigarettes, abstinence self-efficacy, and quit outcomes in a pilot smoking cessation trial.
   Giummo R, Oliver JA, McClernon FJ, Sweitzer MM. · · 2024 · cited 1× · PMID 39024797 · DOI 10.1016/j.drugalcdep.2024.111393