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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
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
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 moreSide effects data
From 2022 Phase 2 trial • 182 Patients • NCT0296687319%
Gastrointestinal Discomfort
16%
Viral Upper Respiratory Tract Infections (Cold)
10%
Nausea
10%
Injury
9%
Muscle or Joint Pain
5%
Flatulence
4%
Headache/Migraine
3%
Sinusitis
2%
Pneumonia
2%
Anxiety
2%
Constipation
1%
Stroke
1%
Sepsis
1%
Pancreatitis
1%
Bladder Infection
1%
Injury/Accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetylcysteine (NAC) Treatment Group
Placebo Group
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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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,369 Total Patients Enrolled
1 Trials studying Nicotine Addiction
77 Patients Enrolled for Nicotine Addiction
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,320 Total Patients Enrolled
3 Trials studying Nicotine Addiction
326 Patients Enrolled for Nicotine Addiction
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,185 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,106 Patients Enrolled for Nicotine Addiction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you are addicted to any substances other than nicotine.You are a healthy adult between the ages of 25 and 65, and have a history of smoking at least 10 cigarettes per day for 3 years or more.
Research Study Groups:
This trial has the following groups:- Group 1: R-E (Retrieval Extinction) with no fMRI
- Group 2: R-E (Retrieval Extinction) with fMRI
- Group 3: NR-E (No R-E) with no fMRI
- Group 4: NR-E (No R-E) with fMRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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