Extinction Updating in Reconsolidation

NCT02154685 | Completed DMC

• 1 other identifier: 25623
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Addiction; Smoking Cessation

Keywords

Smoking; Nicotine; Addiction; Cessation

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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.

Study Arms (2)

Retrieval-Extinction: Smoking Cues

OTHER

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

Behavioral: Retrieval-Extinction

Non-Retrieval Extinction: Neutral Cues

OTHER

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

Behavioral: Non-Retrieval Extinction

Interventions

Retrieval-Extinction BEHAVIORAL

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

Also known as: R-E

Retrieval-Extinction: Smoking Cues

Non-Retrieval Extinction BEHAVIORAL

Neutral cue exposure.

Also known as: NR-E

Non-Retrieval Extinction: Neutral Cues

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 29597136 DERIVED

• 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.

  PMID: 28146243 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Michael Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: June 3, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-04

Locations

US (1)