Extinction Updating in Reconsolidation

Smoking Cessation Clinical Trial

Official title:

Reducing Smoking Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154685
• Other study ID #: 25623
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: October 1, 2015
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Addiction
• Smoking Cessation

Intervention

Behavioral:
• Retrieval-Extinction
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 cue exposure.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No