Extinction Updating in Reconsolidation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nicotine Addiction Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Retrieval-Extinction: Smoking Cues

A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.

Group Type OTHER

Retrieval-Extinction

Intervention Type BEHAVIORAL

A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.

Non-Retrieval Extinction: Neutral Cues

This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.

Group Type OTHER

Non-Retrieval Extinction

Intervention Type BEHAVIORAL

Neutral cue exposure.

Interventions

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Retrieval-Extinction

A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.

Intervention Type BEHAVIORAL

Non-Retrieval Extinction

Neutral cue exposure.

Intervention Type BEHAVIORAL

Other Intervention Names

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R-E NR-E

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes