Extinction Updating in Reconsolidation

October 1, 2015 updated by: Medical University of South Carolina

Reducing Smoking Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: Retrieval-Extinction
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
Other: Non-Retrieval Extinction: Neutral Cues
This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.
Behavioral: Non-Retrieval Extinction
Neutral cue exposure.
Other Names:
  • NR-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of the Difference in Nicotine Craving between Visits 1 and 2
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.
A craving questionnaire and mood form is given to participants to complete at several time points throughout the visit to access nicotine craving.
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.
Change in Nicotine Use at 2-Week Follow-Up
Time Frame: A diary is given to participants to record their smoking behaviors everyday for two weeks.
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.
A diary is given to participants to record their smoking behaviors everyday for two weeks.
Change in Nicotine Use at 4-Week Follow-up
Time Frame: A diary is given to participants to record their smoking behaviors everyday for two weeks.
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.
A diary is given to participants to record their smoking behaviors everyday for two weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25623

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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