Extinction Updating in Reconsolidation

Completed · Not applicable

Conditions studied: Nicotine Addiction, Smoking Cessation

In brief

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.

Key facts

Study ID

NCT02154685

Run by

Medical University of South Carolina

People needed

77

Starts

2013-12-01

Expected to finish

2015-09-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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 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).

Where it is running

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

Full record on ClinicalTrials.gov

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