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Behavioral Memory Modulation for Nicotine Addiction

N/A

Waitlist Available

Led By Michael Saladin, PhD

Research Sponsored by Medical University of South Carolina

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 between week 1 and week 26

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new method to help smokers quit by reducing cravings.

Who is the study for?

This trial is for healthy adults aged 25-65 who have smoked at least 10 cigarettes daily for over 3 years. They must live within a 50-mile radius of the research site, have reliable transport, and not use other smoking cessation aids during the study. Participants should be willing to stop smoking before certain visits and stay smoke-free for four days.

What is being tested?

The study tests if Retrieval Extinction Training (RET), a behavioral intervention, can reduce cravings and alter smoking behavior in response to nicotine cues. Some participants will undergo RET with fMRI scanning while others without it or may receive control treatments.

What are the potential side effects?

Since this trial involves behavioral training rather than medication, traditional side effects are not expected. However, participants might experience discomfort from abstaining from smoking or stress due to participation requirements like MRI scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between week 1 and week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between week 1 and week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and between week 1 and week 26 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean Change in Blood Pressure

Mean Change in Heart Rate

Mean Change in Skin Conductance

+2 more

Side effects data

From 2022 Phase 2 trial • 182 Patients • NCT02966873

19%

Gastrointestinal Discomfort

16%

Viral Upper Respiratory Tract Infections (Cold)

10%

Nausea

10%

Injury

Muscle or Joint Pain

Flatulence

Headache/Migraine

Sinusitis

Pneumonia

Anxiety

Constipation

Stroke

Sepsis

Pancreatitis

Bladder Infection

Injury/Accident

100%

80%

60%

40%

20%

Study treatment Arm

N-Acetylcysteine (NAC) Treatment Group

Placebo Group

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: R-E (Retrieval Extinction) with no fMRIExperimental Treatment2 Interventions

49 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test that is equivalent to the task that the R-E with fMRI arm receives in the fMRI scanner. This arm participates in the no functional magnetic resonance imaging (fMRI) intervention.

Group II: R-E (Retrieval Extinction) with fMRIExperimental Treatment2 Interventions

34 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a smoking-related cue-reactivity experience in an fMRI scanner during the baseline assessment and 24-hour follow-up test. This arm participates in the functional magnetic resonance imaging (fMRI) intervention.

Group III: NR-E (No R-E) with no fMRIExperimental Treatment2 Interventions

49 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test that is equivalent to the task that the NR-E with fMRI arm receives in the fMRI scanner. This arm participates in the no functional magnetic resonance imaging (fMRI) intervention.

Group IV: NR-E (No R-E) with fMRIExperimental Treatment2 Interventions

34 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a non-smoking or neutral cue-reactivity experience in an fMRI scanner during the baseline assessment and 24-hour follow-up test. This arm participates in the functional magnetic resonance imaging (fMRI) intervention.

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