Clinical trial NCT03744559: Behavioral Memory Modulation in Nicotine Addiction
Official title: Targeting Foundational Memory Processes in Nicotine Addiction: A Translational Clinical Neuroscience Study of a Retrieval-Extinction Intervention to Reduce Craving and Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Use Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-11-16
Enrollment: 191
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In a recently published NIDA-funded study, the investigators found that lasting reductions in craving and smoking could be achieved with a brief behavioral intervention designed to alter memory processes underlying smoking-related nicotine addiction. The proposed project will replicate and extend these findings by 1) increasing the dose of intervention so as to bolster the observed treatment effects, 2) employing brain imaging methods to identify patterns of brain activity uniquely associated with the intervention and potentially predictive of treatment outcome, 3) extending follow-up period to more completely document the long-term effects of the intervention. Positive findings from this study could lead to the development of brief therapy that will not only improve treatment outcomes for smokers, but also be used in the treatment other substance use disorders and frequently co-occurring comorbidities such as PTSD.

Eligibility criteria: Inclusion Criteria

1. Healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years.
2. Participants must live within a 50-mile radius of the research facility and have reliable transportation.
3. 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.
4. 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).

Exclusion Criteria

1. Participants who are dependent on substances other than nicotine.
2. 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.

Primary outcomes:
measure: Mean Craving Questionnaire Score, Response to the Novel Cue
timeFrame: up to 24 weeks, Baseline, 24 hours, Weeks 2, 4, 6, 8, 12, and 24
measure: Mean Cigarettes Smoked Per Day
timeFrame: up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26
Secondary outcomes:
measure: Percentage of Smoking Days
timeFrame: up to 26 weeks, Baseline, Weeks 2, 4, 6, 8, 12, 16, 21 and 26
measure: Mean Mood-Craving Response to the Novel Cue
timeFrame: up to 24 weeks, Baseline, 24 Hours, Weeks 2, 4, 6, 8, 12, and 24
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Saladin, PhD
role: PRINCIPAL_INVESTIGATOR
References: