Back to resultsExtinction Updating in Reconsolidation
Primary Purpose
Nicotine Addiction, Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrieval-Extinction
Non-Retrieval Extinction
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Addiction focused on measuring Smoking, Nicotine, Addiction, Cessation
Eligibility Criteria
Inclusion Criteria:
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must meet DSM-IV criteria for current nicotine dependence and be a daily cigarette smoker of 10+ cigarettes/day for a minimum duration of three years.
- Participants must live within a 50-mile radius of the research facility and have reliable transportation.
- Participants must be willing to make a quit attempt beginning the night before the three consecutive daily laboratory sessions (i.e., two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session).
- Participants must be willing to (a) be overnight smoking abstinent (CO verified) prior to the baseline smoking cue reactivity assessment, and (b) make a cessation attempt and be smoking abstinent (CO verified) over the three day period that corresponds to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
- Participants must be willing to submit to a breathalyzer (alcohol) assessment and urine drug screen (for benzodiazepines, methamphetamine, cocaine, marijuana and opiates) and produce a negative test result on (a) the day of the baseline smoking cue reactivity assessment, and (b) each of the three consecutive days that correspond to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
- Participants must consent to random assignment to the R-E vs. NR-E conditions.
- Participants must not use smokeless tobacco.
- Participants must be willing to forego any other medication or behavioral treatment for smoking cessation during their enrollment in this study (with the exception of a referral, upon request, to the SC Quitline). Treatment referral will be provided at the end of the study.
Exclusion Criteria:
- Participants with current/active (untreated) psychotic disorder, current major depressive disorder (severe), bipolar affective disorder or a severe anxiety disorder as these conditions would likely interfere with their ability to fulfill the requirements for successful participation (e.g., provide accurate interview data, complete study assessments, attend scheduled laboratory visits, etc.).
- Participants meeting DSM-IV criteria for substance dependence (other than nicotine) within the past 60 days.
- Participants who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (benzodiazepines, methamphetamine, cocaine, marijuana and opiates) in order to comply with Inclusion Criterion f above.
- Participants currently taking ß-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate, skin conductance or blood pressure responses.
- Current use of any pharmacotherapy or psychotherapy for smoking cessation.
- Pregnant women (because pregnancy can influence responding during study procedures).
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Retrieval-Extinction: Smoking Cues
Non-Retrieval Extinction: Neutral Cues
Arm Description
A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.
This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.
Outcomes
Primary Outcome Measures
Mean of the Difference in Nicotine Craving between Visits 1 and 2
A craving questionnaire and mood form is given to participants to complete at several time points throughout the visit to access nicotine craving.
Change in Nicotine Use at 2-Week Follow-Up
At the end of the first (24-hr.) and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
Change in Nicotine Use at 4-Week Follow-up
At the end of the first (24-hr.) and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
Secondary Outcome Measures
Full Information
NCT ID
NCT02154685
First Posted
March 28, 2014
Last Updated
October 1, 2015
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02154685
Brief Title
Extinction Updating in Reconsolidation
Official Title
Reducing Smoking Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Smoking occurs in approximately 21% of the US population, is responsible for an annual mortality rate of approximately 438,000 citizens, and has an associated healthcare economic burden of $167 billion. Although pharmacotherapies have improved cessation outcome, the vast majority of individuals making quit attempts relapse within 5-10 days of cessation. The hypotheses to be examined in this study may have potentially important implications for smoking cessation treatment and will, therefore, target the single greatest addiction-related cause of morbidity and mortality.This study will investigate a novel behavioral strategy for altering important memory processes that underlie human smoking-related nicotine addiction. This strategy used in this study employs established cue exposure procedures to putatively update smoking-related memory with information that will suppress responding to smoking cues. The goal here is to alter existing nicotine-related memory directly rather than rely exclusively on the establishment of an inhibitory extinction process, via traditional cue exposure therapy, which is known to be vulnerable to spontaneous recovery, renewal and reinstatement. Positive findings would represent a significant advance in exposure-based therapy for addiction and could lead to a treatment that uniquely targets the problem of cue-elicited craving and reactivity, thereby addressing a major obstacle to successful smoking cessation.
Detailed Description
We propose to examine the effects of two sessions of retrieval-extinction (R-E) training in smokers who are making a quit attempt. Retrieval will be initiated by a brief (5-min.) video with smoking-related content and the extinction will consist of protracted (1 hr.) exposure to smoking cues. A control group receiving the same treatment except that the retrieval video will have nonsmoking/neutral content will serve to demonstrate that retrieval is a key feature of R-E training. Effects of training on smoking craving and cue reactivity will be assessed 1-day, 2-weeks and 4-weeks post-training, whereas training effects on indices of smoking behavior/cessation will be preliminarily assessed 2-weeks and 4-weeks post-training. It is expected that the R-E training will result in significant and enduring reductions in craving and reactivity to both novel and familiar smoking cues and have a favorable impact on smoking. Positive findings from this study could lead to a safe and effective behavioral intervention that will help smokers overcome the threat to cessation posed by cue-elicited craving and reactivity, and thereby reduce the burden levied against society by this most costly addiction. Additionally, this intervention could be modified to treat addiction to other substances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Smoking Cessation
Keywords
Smoking, Nicotine, Addiction, Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrieval-Extinction: Smoking Cues
Arm Type
Other
Arm Description
A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.
Arm Title
Non-Retrieval Extinction: Neutral Cues
Arm Type
Other
Arm Description
This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.
Intervention Type
Behavioral
Intervention Name(s)
Retrieval-Extinction
Other Intervention Name(s)
R-E
Intervention Description
A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.
Intervention Type
Behavioral
Intervention Name(s)
Non-Retrieval Extinction
Other Intervention Name(s)
NR-E
Intervention Description
Neutral cue exposure.
Primary Outcome Measure Information:
Title
Mean of the Difference in Nicotine Craving between Visits 1 and 2
Description
A craving questionnaire and mood form is given to participants to complete at several time points throughout the visit to access nicotine craving.
Time Frame
Multiple times points during Visits 1, 2 and 3 (the two retreival sessions and the first test session) as well as the 2-week and 4-week follow-up laboratory test sessions.
Title
Change in Nicotine Use at 2-Week Follow-Up
Description
At the end of the first (24-hr.) and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
Time Frame
A diary is given to participants to record their smoking behaviors everyday for two weeks.
Title
Change in Nicotine Use at 4-Week Follow-up
Description
At the end of the first (24-hr.) and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
Time Frame
A diary is given to participants to record their smoking behaviors everyday for two weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Participants must meet DSM-IV criteria for current nicotine dependence and be a daily cigarette smoker of 10+ cigarettes/day for a minimum duration of three years.
Participants must live within a 50-mile radius of the research facility and have reliable transportation.
Participants must be willing to make a quit attempt beginning the night before the three consecutive daily laboratory sessions (i.e., two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session).
Participants must be willing to (a) be overnight smoking abstinent (CO verified) prior to the baseline smoking cue reactivity assessment, and (b) make a cessation attempt and be smoking abstinent (CO verified) over the three day period that corresponds to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
Participants must be willing to submit to a breathalyzer (alcohol) assessment and urine drug screen (for benzodiazepines, methamphetamine, cocaine, marijuana and opiates) and produce a negative test result on (a) the day of the baseline smoking cue reactivity assessment, and (b) each of the three consecutive days that correspond to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
Participants must consent to random assignment to the R-E vs. NR-E conditions.
Participants must not use smokeless tobacco.
Participants must be willing to forego any other medication or behavioral treatment for smoking cessation during their enrollment in this study (with the exception of a referral, upon request, to the SC Quitline). Treatment referral will be provided at the end of the study.
Exclusion Criteria:
Participants with current/active (untreated) psychotic disorder, current major depressive disorder (severe), bipolar affective disorder or a severe anxiety disorder as these conditions would likely interfere with their ability to fulfill the requirements for successful participation (e.g., provide accurate interview data, complete study assessments, attend scheduled laboratory visits, etc.).
Participants meeting DSM-IV criteria for substance dependence (other than nicotine) within the past 60 days.
Participants who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (benzodiazepines, methamphetamine, cocaine, marijuana and opiates) in order to comply with Inclusion Criterion f above.
Participants currently taking ß-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate, skin conductance or blood pressure responses.
Current use of any pharmacotherapy or psychotherapy for smoking cessation.
Pregnant women (because pregnancy can influence responding during study procedures).
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
Citations:
PubMed Identifier
29597136
Citation
Germeroth LJ, Baker NL, Saladin ME. Intolerance for smoking abstinence among nicotine-deprived, treatment-seeking smokers. Addict Behav. 2018 Sep;84:13-19. doi: 10.1016/j.addbeh.2018.03.019. Epub 2018 Mar 20.
Results Reference
derived
PubMed Identifier
28146243
Citation
Germeroth LJ, Carpenter MJ, Baker NL, Froeliger B, LaRowe SD, Saladin ME. Effect of a Brief Memory Updating Intervention on Smoking Behavior: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Mar 1;74(3):214-223. doi: 10.1001/jamapsychiatry.2016.3148.
Results Reference
derived
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Extinction Updating in Reconsolidation
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