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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,069 Total Patients Enrolled

1 Trials studying Nicotine Addiction

77 Patients Enrolled for Nicotine Addiction

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,397 Total Patients Enrolled

3 Trials studying Nicotine Addiction

327 Patients Enrolled for Nicotine Addiction

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,402 Total Patients Enrolled

15 Trials studying Nicotine Addiction

2,130 Patients Enrolled for Nicotine Addiction

Media Library

Control Retrieval Extinction Training (RET) Clinical Trial Eligibility Overview. Trial Name: NCT03744559 — N/A

Nicotine Addiction Research Study Groups: R-E (Retrieval Extinction) with no fMRI, R-E (Retrieval Extinction) with fMRI, NR-E (No R-E) with no fMRI, NR-E (No R-E) with fMRI

Nicotine Addiction Clinical Trial 2023: Control Retrieval Extinction Training (RET) Highlights & Side Effects. Trial Name: NCT03744559 — N/A

Control Retrieval Extinction Training (RET) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03744559 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential participants meet to be eligible for this research endeavor?

"This clinical trial is targeting 166 individuals with nicotine use disorder aged 25 to 65. Candidates must be situated within a 50-mile radius of the research facility and possess reliable transportation, consist of healthy men/women that have smoked at least 10 cigarettes per day for 3 years, as well as willing to abstain from smoking beginning on the night before baseline visit and starting again prior to visit one while remaining smokefree for four consecutive days."

Answered by AI

Is enrollment still available for this experiment?

"Yes, the most up-to-date figures from clinicaltrials.gov confirms that this medical trial is actively recruiting and requires 166 participants to be sourced from a single site. This study was first posted on February 4th 2019 and last updated on June 30th 2022."

Answered by AI

What is the total cohort size for this research program?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is currently recruiting participants and was initially posted in February 4th 2019 before its last modification on June 30th 2022. The study seeks 166 patients from a single medical centre."

Answered by AI