Behavioral Memory Modulation in Nicotine Addiction

NCT03744559 | Completed Results

• 2 other identifiers: 00069355R01DA043587
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if a behavioral intervention known as retrieval-extinction training (RET) might affect craving in response to nicotine cues (e.g., pictures, videos and objects) and smoking behavior in men and women who smoke cigarettes.

Conditions

Nicotine Use Disorder

Outcome Measures

Primary Outcomes (2)

• Mean Craving Questionnaire Score, Response to the Novel Cue

  At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Craving Questionnaire survey at multiple timepoints during each visit (baseline, and after each cue exposure). The craving questionnaire is the average of four statements about craving for cigarettes (e.g., "I have an urge for a cigarette"), and the participants rate how they agree with the statements at that moment on a scale of 1 to 5 (1 = strongly disagree and 5 = strongly agree). This measure will examine the behavioral response to the novel cue over the course of the study, and differences in response between the R-E arms and NR-E arms.

  up to 24 weeks, Baseline, 24 hours, Weeks 2, 4, 6, 8, 12, and 24

• Mean Cigarettes Smoked Per Day

  Cigarettes Smoked per Day were recorded daily and summarized at follow-up visits

  up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26

Secondary Outcomes (2)

• Percentage of Smoking Days

  up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26

• Mean Mood-Craving Response to the Novel Cue

  up to 24 weeks, Baseline, 24 Hours, Weeks 2, 4, 6, 8, 12, and 24

Study Arms (2)

R-E (Retrieval Extinction)

EXPERIMENTAL

83 anticipated participants will undergo 3 sessions on consecutive days of the Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' smoking-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of smoking-related cues (e.g., pictures). Participants will also receive a lab-based smoking-related cue-reactivity experience during the baseline assessment and 24-hour follow-up test.

Behavioral: Retrieval Extinction Training (RET)

NR-E (No R-E)

OTHER

83 anticipated participants will undergo 3 sessions on consecutive days of the control Retrieval Extinction Training (RET) intervention consisting of a 5-minute 'retrieval' non-smoking or neutral-content video followed 10 minutes later by 1 hour of 'extinction' training consisting of four sequences of non-smoking or neutral cues (e.g., pictures). Participants will also receive a lab-based non-smoking or neutral cue-reactivity experience during the baseline assessment and 24-hour follow-up test.

Behavioral: Control Retrieval Extinction Training (RET)

Interventions

Retrieval Extinction Training (RET) BEHAVIORAL

Retrieval extinction training (RET) is a behavioral intervention that involves cue-elicited retrieval followed by extinction training (i.e., massed unreinforced exposure to drug-associated cues). The first element of RET involves briefly presenting drug-associated cues to retrieve drug use memories. The second element, occurring after a brief interval, involves extinction training. It is argued that the initial retrieval of the memories prior to extinction training initiates a period of instability, which is followed by reconsolidation of the memories back into long-term storage. Extinction training during the period of instability is presumed to overwrite the original drug-associated cue with a non-drug-associated cue, to attenuate expression of drug-seeking behavior.

R-E (Retrieval Extinction)

Control Retrieval Extinction Training (RET) BEHAVIORAL

The control retrieval extinction training (RET) for the NR-E arms serves as the control intervention to the RET behavioral intervention. The first element of the control RET involves briefly presenting retrieval cues that contain neutral, non-smoking content. The second element, occurring after a brief interval, involves extinction training. Based on findings from the previous NIDA-funded R21, the R-E arm reported a significant 25 percent reduction in cigarettes smoked per day during the follow-up period versus the control NR-E arm.

NR-E (No R-E)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years.
• Participants must live within a 50-mile radius of the research facility and have reliable transportation.
• Participants must be willing to abstain from smoking starting the night before the baseline visit, and starting the night before visit 1 and remain abstinent for four consecutive days.
• Participants must agree to forego any other medication or behavioral treatment for smoking cessation while enrolled in the study (with the exception of the SC Quitline).

You may not qualify if:

• Participants who are dependent on substances other than nicotine.
• Women who are pregnant during the clinical assessment session or either of the fMRI sessions. These participants must agree to notify the study staff if they become pregnant during the study.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Michael Saladin
• Organization: Medical University of South Carolina

saladinm@musc.edu

(843) 792-5306

Study Officials

• Michael Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 13, 2018
• First Posted: November 16, 2018
• Study Start: February 4, 2019
• Primary Completion: October 28, 2023
• Study Completion: November 1, 2023
• Last Updated: April 30, 2025
• Results First Posted: December 18, 2024

Record last verified: 2025-04

Locations

US (1)