Behavioral Memory Modulation in Nicotine Addiction

Not Applicable

Active, not recruiting

• Conditions: Nicotine Use Disorder
• Interventions: Behavioral: Retrieval Extinction Training (RET); Behavioral: Control Retrieval Extinction Training (RET); Other: Functional magnetic resonance imaging (fMRI); Other: No functional magnetic resonance imaging (fMRI)

• Registration Number: NCT03744559
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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 (e.g., pictures, videos and objects) and smoking behavior in men and women who smoke cigarettes.

Detailed Description

In a recently published NIDA-funded study, the investigators found that lasting reductions in craving and smoking could be achieved with a brief behavioral intervention designed to alter memory processes underlying smoking-related nicotine addiction. The proposed project will replicate and extend these findings by 1) increasing the dose of intervention so as to bolster the observed treatment effects, 2) employing brain imaging methods to identify patterns of brain activity uniquely associated with the intervention and potentially predictive of treatment outcome, 3) extending follow-up period to more completely document the long-term effects of the intervention. Positive findings from this study could lead to the development of brief therapy that will not only improve treatment outcomes for smokers, but also be used in the treatment other substance use disorders and frequently co-occurring comorbidities such as PTSD.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-16
• Study Start: 2019-02-04
• Primary Completion: 2023-10-28
• Results First Submitted: 2024-10-16
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-E (Retrieval Extinction) with fMRI	Retrieval Extinction Training (RET)	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.
NR-E (No R-E) with no fMRI	Control Retrieval Extinction Training (RET)	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.
R-E (Retrieval Extinction) with no fMRI	Retrieval Extinction Training (RET)	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.
NR-E (No R-E) with fMRI	Functional magnetic resonance imaging (fMRI)	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.
R-E (Retrieval Extinction) with no fMRI	No functional magnetic resonance imaging (fMRI)	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.
R-E (Retrieval Extinction) with fMRI	Functional magnetic resonance imaging (fMRI)	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.
NR-E (No R-E) with no fMRI	No functional magnetic resonance imaging (fMRI)	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.
NR-E (No R-E) with fMRI	Control Retrieval Extinction Training (RET)	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.

Primary Outcome Measures

Name	Time	Method
Mean Craving Questionnaire Score, Response to the Novel Cue	up to 24 weeks, Baseline, 24 hours, Weeks 2, 4, 6, 8, 12, and 24	At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Craving Questionnaire survey at multiple timepoints during each visit (baseline, and after each cue exposure). The craving questionnaire is the average of four statements about craving for cigarettes (e.g., "I have an urge for a cigarette"), and the participants rate how they agree with the statements at that moment on a scale of 1 to 5 (1 = strongly disagree and 5 = strongly agree). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.
Mean Cigarettes Smoked Per Day	up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26	Cigarettes Smoked per Day were recorded daily and summarized at follow-up visits

Secondary Outcome Measures

Name	Time	Method
Percentage of Smoking Days	up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26	Cigarettes Smoking days were recorded daily and summarized at follow-up visits. The percentage of days since last follow up visit where smoking is recorded is reported
Mean Mood-Craving Response to the Novel Cue	up to 24 weeks, Baseline, 24 Hours, Weeks 2, 4, 6, 8, 12, and 24	At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a mood craving during each visit. The mood craving form is a single item question ranging from 0 (no craving) to 100 (greatest craving possible). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States