Back to resultsBehavioral Memory Modulation in Nicotine Addiction
Primary Purpose
Nicotine Use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrieval Extinction Training (RET)
Control Retrieval Extinction Training (RET)
Functional magnetic resonance imaging (fMRI)
No functional magnetic resonance imaging (fMRI)
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Use Disorder
Eligibility Criteria
Inclusion Criteria
- Healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years.
- Participants must live within a 50-mile radius of the research facility and have reliable transportation.
- Participants must be willing to abstain from smoking starting the night before the baseline visit, and starting the night before visit 1 and remain abstinent for four consecutive days.
- 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
- Participants who are dependent on 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
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
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Mean Change on Craving Questionnaire Score
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 lists 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 change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Mean Change on Mood Form Score
At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Mood Form survey at multiple timepoints during each visit (baseline, and after each cue exposure). The mood form lists nine moods or emotions (e.g., "Happy" or "Unhappy"), and the participants rate how they are experiencing the moods at that moment on a scale of 0 to 6 (0 = Not at all and 6 = Extremely). This measure will examine change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and the NR-E arms.
Mean Change in Heart Rate
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant heart rate at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two electrodes affixed to the participants' ribcage or wrists to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Mean Change in Skin Conductance
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant skin conductance at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two Ag/AgCI electrodes attached to the second phalanx of the first and third fingers of the participants' non-dominant hand to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Mean Change in Blood Pressure
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant blood pressure (both systolic and diastolic pressures) at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a non-invasive arm cuff to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Secondary Outcome Measures
Full Information
NCT ID
NCT03744559
First Posted
November 13, 2018
Last Updated
July 21, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03744559
Brief Title
Behavioral Memory Modulation in Nicotine Addiction
Official Title
Targeting Foundational Memory Processes in Nicotine Addiction: A Translational Clinical Neuroscience Study of a Retrieval-Extinction Intervention to Reduce Craving and Smoking Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R-E (Retrieval Extinction) with no fMRI
Arm Type
Experimental
Arm Description
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.
Arm Title
R-E (Retrieval Extinction) with fMRI
Arm Type
Experimental
Arm Description
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.
Arm Title
NR-E (No R-E) with no fMRI
Arm Type
Other
Arm Description
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.
Arm Title
NR-E (No R-E) with fMRI
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Retrieval Extinction Training (RET)
Intervention Description
Retrieval extinction training (RET) is a behavioral intervention that involves cue-elicited retrieval followed by extinction training (i.e., massed unreinforced exposure to drug-associated cues). The first element of RET involves briefly presenting drug-associated cues to retrieve drug use memories. The second element, occurring after a brief interval, involves extinction training. It is argued that the initial retrieval of the memories prior to extinction training initiates a period of instability, which is followed by reconsolidation of the memories back into long-term storage. Extinction training during the period of instability is presumed to overwrite the original drug-associated cue with a non-drug-associated cue, to attenuate expression of drug-seeking behavior.
Intervention Type
Behavioral
Intervention Name(s)
Control Retrieval Extinction Training (RET)
Intervention Description
The control retrieval extinction training (RET) for the NR-E arms serves as the control intervention to the RET behavioral intervention. The first element of the control RET involves briefly presenting retrieval cues that contain neutral, non-smoking content. The second element, occurring after a brief interval, involves extinction training. Based on findings from the previous NIDA-funded R21, the R-E arm reported a significant 25 percent reduction in cigarettes smoked per day during the follow-up period versus the control NR-E arm.
Intervention Type
Other
Intervention Name(s)
Functional magnetic resonance imaging (fMRI)
Intervention Description
Functional magnetic resonance imaging (fMRI) will identify patterns of brain activity associated with RET and potentially predictive of treatment outcomes. The fMRI is used during the baseline and 24-hour follow-up test sessions while participants complete a cue-reactivity task. The collection of fMRI data is based on findings from human fear conditioning fMRI studies, in which groups receiving RET in the reconsolidation window exhibited less fear that was associated with attenuated BOLD response in the amygdala, relative to the control. We propose that the R-E arm will evidence attenuated cue reactivity in medial prefrontal cortex, limbic regions and ventral striatum, and that greater reduction in BOLD response in regions of interest will predict decreased smoking.
Intervention Type
Other
Intervention Name(s)
No functional magnetic resonance imaging (fMRI)
Intervention Description
No functional magnetic resonance imaging (fMRI) serves as the control intervention to the fMRI intervention. Participants who are randomized to the no fMRI intervention or who have a contraindication to MRI will complete an identical cue-reactivity task in a cue-reactivity lab during the baseline and 24-hour follow-up test sessions.
Primary Outcome Measure Information:
Title
Mean Change on Craving Questionnaire Score
Description
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 lists 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 change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Time Frame
Between Week 1 and Week 26
Title
Mean Change on Mood Form Score
Description
At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Mood Form survey at multiple timepoints during each visit (baseline, and after each cue exposure). The mood form lists nine moods or emotions (e.g., "Happy" or "Unhappy"), and the participants rate how they are experiencing the moods at that moment on a scale of 0 to 6 (0 = Not at all and 6 = Extremely). This measure will examine change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and the NR-E arms.
Time Frame
Between Week 1 and Week 26
Title
Mean Change in Heart Rate
Description
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant heart rate at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two electrodes affixed to the participants' ribcage or wrists to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Time Frame
Between Week 1 and Week 26
Title
Mean Change in Skin Conductance
Description
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant skin conductance at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two Ag/AgCI electrodes attached to the second phalanx of the first and third fingers of the participants' non-dominant hand to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Time Frame
Between Week 1 and Week 26
Title
Mean Change in Blood Pressure
Description
At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant blood pressure (both systolic and diastolic pressures) at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a non-invasive arm cuff to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms.
Time Frame
Between Week 1 and Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years.
Participants must live within a 50-mile radius of the research facility and have reliable transportation.
Participants must be willing to abstain from smoking starting the night before the baseline visit, and starting the night before visit 1 and remain abstinent for four consecutive days.
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
Participants who are dependent on 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Saladin, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Memory Modulation in Nicotine Addiction
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