Behavioral Memory Modulation for Nicotine Addiction

Overseen By Shannon Wnorowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Substance dependence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

191 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special behavioral technique, called retrieval-extinction training (RET), can help reduce cravings and smoking in cigarette smokers. Participants will watch a video about smoking and then attend sessions designed to weaken their response to smoking triggers like pictures or videos. Two groups will be formed: one will experience smoking-related cues, while the other will be exposed to neutral, non-smoking cues. The trial seeks healthy men and women who have smoked at least 10 cigarettes a day for 3 years and live near the research center. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new methods for reducing smoking cravings.

What prior data suggests that this behavioral intervention is safe for participants?

Research shows that retrieval-extinction training (RET) is being explored as a method to help reduce cravings in people who smoke. Previous studies have shown RET's potential to change reactions to smoking-related cues.

Some studies suggest that RET might reduce cravings when people see smoking-related images or videos. However, other research has found that it could sometimes increase cravings in certain situations.

Overall, RET remains under investigation. While it might be helpful, there is also a chance of negative effects. Participants should be aware of these mixed results when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to tackling nicotine addiction by targeting memory processes associated with smoking habits. Unlike standard treatments like nicotine replacement therapy or medications such as varenicline, these methods use Retrieval Extinction Training (RET) to modify the emotional and habitual responses tied to smoking cues. By showing participants smoking-related or neutral content and then engaging them in extinction training, the goal is to weaken the automatic urge to smoke when faced with such cues. This innovative approach aims to reduce cravings and potentially lead to longer-lasting results with fewer sessions than traditional therapies.

What evidence suggests that this trial's treatments could be effective for nicotine addiction?

This trial will compare two approaches: Retrieval Extinction Training (RET) and a control version of RET. Studies have shown that RET can reduce cravings related to addiction by altering how memories are stored in the brain. This method has shown promise in reducing cravings and changing addictive behaviors, such as smoking. Research indicates that RET can help individuals react less to smoking triggers, like images or videos that remind them of smoking. This suggests that RET might effectively help people quit smoking or reduce their cravings. ^{1 2 5 6 7}

Who Is on the Research Team?

Michael Saladin, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must live within a 50-mile radius of the research facility and have reliable transportation.

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.

Participants must agree to forego any other medication or behavioral treatment for smoking cessation while enrolled in the study (with the exception of the SC Quitline).

Exclusion Criteria

You cannot participate if you are addicted to any substances other than nicotine.

Women who are pregnant during the clinical assessment session or either of the fMRI sessions. These participants must agree to notify the study staff if they become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a lab-based smoking-related or non-smoking cue-reactivity experience

1 day

1 visit (in-person)

Intervention

Participants undergo 3 sessions of Retrieval Extinction Training (RET) or control intervention on consecutive days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up tests and questionnaires

26 weeks

Multiple visits at Weeks 2, 4, 6, 8, 12, 16, 21, and 26

What Are the Treatments Tested in This Trial?

Interventions

• Control Retrieval Extinction Training (RET)
• Retrieval Extinction Training (RET)

Trial Overview 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.

How Is the Trial Designed?

Group I: R-E (Retrieval Extinction) Experimental Treatment 1 Intervention

83 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.

Group II: NR-E (No R-E) Experimental Treatment 1 Intervention

83 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535158/

A novel imagery-based retrieval-extinction training for ... Retrieval-extinction training based on the theory of memory reconsolidation has promising intervention effects for addiction.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41107816/

A novel imagery-based retrieval-extinction training ... Background: Retrieval-extinction training based on the theory of memory reconsolidation has promising intervention effects for addiction.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03744559

Behavioral Memory Modulation in Nicotine Addiction | ... The purpose of the study is to see if a behavioral intervention known as retrieval-extinction training (RET) might affect craving in response to nicotine cues ( ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2600224

Effect of a Brief Memory Updating Intervention on Smoking ... This randomized clinical trial examines whether smoking- or nonsmoking-related retrieval-extinction training could attenuate smoking-related

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724000570

rTMS effects on urges and severity of tobacco use disorder ... The present study evaluated the neural features underlying effects of repetitive transcranial magnetic stimulation (rTMS) for reducing smoking cravings.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02154685

NCT02154685 | Extinction Updating in Reconsolidation A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training. Other Names: R-E.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6803535/

Detrimental Effects of a Retrieval-Extinction Procedure on ... This study revealed a heretofore unreported and paradoxical detrimental effect of retrieval-extinction memory reactivation procedures on extinction of nicotine ...