What is the mechanism of action of this treatment?

Common smoking cessation treatments include behavioral therapies like Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET), which focus on modifying psychological processes and coping strategies to help patients quit smoking. Pharmacological treatments such as nicotine replacement therapy (NRT), varenicline, and bupropion reduce withdrawal symptoms and cravings. These treatments are crucial as they address both the psychological and physiological aspects of nicotine addiction, aiding in preventing lapses and achieving long-term cessation. Functional Magnetic Resonance Imaging (fMRI) studies can further elucidate how these treatments impact brain activity and mental processes, potentially leading to more effective interventions.

What side effects are associated with this type of intervention?

Common treatments for smoking cessation include pharmacological options like nicotine replacement therapy (NRT), varenicline, and bupropion, as well as behavioral therapies such as cognitive-behavioral therapy (CBT) and mindfulness-based interventions. NRT can cause side effects like skin irritation (patches), mouth irritation (lozenges), and insomnia. Varenicline may lead to nausea, vivid dreams, and mood changes. Bupropion is associated with insomnia, dry mouth, and an increased risk of seizures. Behavioral therapies generally have fewer side effects but may include initial increases in anxiety or emotional discomfort as individuals confront their smoking habits.

What prior FDA approvals exist?

The FDA has approved several drugs for smoking cessation, including varenicline and bupropion. Varenicline, a selective nicotinic acetylcholine receptor agonist, is designed to reduce cravings and withdrawal symptoms by targeting brain receptors involved in nicotine addiction. Bupropion, an atypical antidepressant, also aids in smoking cessation by affecting neurotransmitters related to mood and addiction. Both drugs have been studied for their impact on brain activity patterns, which is relevant to understanding the mental processes leading to smoking lapses.

What other types of research exist?

Promising, novel alternatives to fMRI for characterizing brain activity patterns related to mental processes leading to smoking lapses include Technetium-99m (Tc-99m) hexamethylpropylene amine oxime single-photon emission computed tomography (HMPAO SPECT), fludeoxyglucose positron emission tomography (FDG-PET), and computed tomography (CT) perfusion. Additionally, leveraging artificial intelligence and big data to develop integrated algorithms for neuroimaging could enhance diagnosis and treatment.

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Brain Network Dynamics Study for Smoking Relapse Prevention

N/A

Recruiting

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 (visit 2)

Awards & highlights

No Placebo-Only Group

Summary

This trial uses brain scans to understand why people trying to quit smoking end up smoking again. It focuses on adults who smoke and examines how their brain activity changes right before they start smoking again. By studying these changes, researchers hope to find better ways to help people quit smoking for good.

Who is the study for?

This trial is for smokers aged 21-65 who have smoked at least six cigarettes daily over the past year and can speak English fluently. They must pass an MRI safety screening and show a carbon monoxide level above 10 ppm to confirm smoking status. Those unwilling to abstain from nicotine for 12 hours before lab visits or with risks related to MRIs, like pacemakers or metallic objects in their body, cannot join.

What is being tested?

The study uses fMRI scans while participants perform tasks that simulate situations leading to a smoking lapse. It aims to identify brain activity patterns linked to the urge of smoking and understand mental processes preceding a lapse, which could help prevent relapses.

What are the potential side effects?

There are no direct side effects mentioned for this trial as it involves non-invasive fMRI scanning and laboratory tasks without medication intervention. However, discomfort from abstaining from nicotine or staying still during MRI may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 (visit 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 (visit 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 (visit 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood-oxygen-level dependent (BOLD) signal

Self-reported affect

Secondary study objectives

Self-reported craving and nicotine withdrawal symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: fMRI smoking lapse taskExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common smoking cessation treatments include behavioral therapies like Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET), which focus on modifying psychological processes and coping strategies to help patients quit smoking. Pharmacological treatments such as nicotine replacement therapy (NRT), varenicline, and bupropion reduce withdrawal symptoms and cravings. These treatments are crucial as they address both the psychological and physiological aspects of nicotine addiction, aiding in preventing lapses and achieving long-term cessation. Functional Magnetic Resonance Imaging (fMRI) studies can further elucidate how these treatments impact brain activity and mental processes, potentially leading to more effective interventions.

[Cigarette smoking. A pilot project of dehabituation and experimental research].The effect of biofeedback on smoking cessation-a systematic short review.Mindfulness for smoking cessation.