Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03744559
Other study ID # 00069355
Secondary ID R01DA043587
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 4, 2019
Est. completion date January 2025

Study information

Verified date April 2024
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 191
Est. completion date January 2025
Est. primary completion date October 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Retrieval Extinction Training (RET)
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.
Control Retrieval Extinction Training (RET)
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.
Other:
Functional magnetic resonance imaging (fMRI)
Functional magnetic resonance imaging (fMRI) will identify patterns of brain activity associated with RET and potentially predictive of treatment outcomes. The fMRI is used during the baseline and 24-hour follow-up test sessions while participants complete a cue-reactivity task. The collection of fMRI data is based on findings from human fear conditioning fMRI studies, in which groups receiving RET in the reconsolidation window exhibited less fear that was associated with attenuated BOLD response in the amygdala, relative to the control. We propose that the R-E arm will evidence attenuated cue reactivity in medial prefrontal cortex, limbic regions and ventral striatum, and that greater reduction in BOLD response in regions of interest will predict decreased smoking.
No functional magnetic resonance imaging (fMRI)
No functional magnetic resonance imaging (fMRI) serves as the control intervention to the fMRI intervention. Participants who are randomized to the no fMRI intervention or who have a contraindication to MRI will complete an identical cue-reactivity task in a cue-reactivity lab during the baseline and 24-hour follow-up test sessions.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change on Craving Questionnaire Score 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 lists 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 change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms. Between Week 1 and Week 26
Primary Mean Change on Mood Form Score At each visit (baseline, intervention sessions, and follow-up test sessions), participants will complete a Mood Form survey at multiple timepoints during each visit (baseline, and after each cue exposure). The mood form lists nine moods or emotions (e.g., "Happy" or "Unhappy"), and the participants rate how they are experiencing the moods at that moment on a scale of 0 to 6 (0 = Not at all and 6 = Extremely). This measure will examine change in behavioral response to cues over the course of the study, and differences in response between the R-E arms and the NR-E arms. Between Week 1 and Week 26
Primary Mean Change in Heart Rate At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant heart rate at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two electrodes affixed to the participants' ribcage or wrists to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms. Between Week 1 and Week 26
Primary Mean Change in Skin Conductance At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant skin conductance at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a BIOPAC MP100 data acquisition system using two Ag/AgCI electrodes attached to the second phalanx of the first and third fingers of the participants' non-dominant hand to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms. Between Week 1 and Week 26
Primary Mean Change in Blood Pressure At each visit (baseline, intervention sessions, and follow-up test sessions), study staff will collect participant blood pressure (both systolic and diastolic pressures) at multiple timepoints during each visit (baseline, and after each cue exposure). Study staff will connect participants to a non-invasive arm cuff to collect this data. This measure will examine change in physiological response to cues over the course of the study, and differences in response between the R-E arms and NR-E arms. Between Week 1 and Week 26
See also
  Status Clinical Trial Phase
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02511704 - Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette Phase 1
Completed NCT04568395 - Acute Effects of TCIG vs ECIG in PLWH N/A
Completed NCT03338933 - Neurobiology of Alcohol and Nicotine Co-Addiction
Completed NCT03634839 - Effects of E-cigarette Flavors on Youth TCORS 2.0 Phase 1
Recruiting NCT05515354 - Smoking Cessation and Menstrual Cycle Phase Phase 4
Withdrawn NCT06259630 - Nicotine Virtual Reality Conditioned Place Preference Phase 4
Recruiting NCT06170138 - Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users N/A
Not yet recruiting NCT05932745 - Effects of Novel E-cigarette Constituents on Adults TCORS 3.0 N/A
Not yet recruiting NCT03264755 - Cortical Excitability and Role of rTMS in Nicotine Use Disorder N/A
Recruiting NCT05766254 - Identify the Optimal TMS Target to Modulate Reward Activity N/A
Completed NCT00330187 - Combined Pharmaco/Behavior Therapy in Adolescent Smokers Phase 2
Completed NCT03635333 - Effects of E-Cigarette Flavors on Adults TCORS 2.0 Phase 1
Completed NCT03438188 - Neural Basis of Eating Behavior in Abstinent Smokers N/A
Completed NCT03194958 - Helping Poor Smokers Quit N/A
Recruiting NCT04432064 - Temporal Interference Neurostimulation and Addiction N/A
Recruiting NCT05181891 - Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking Phase 2
Completed NCT05897242 - A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults N/A
Not yet recruiting NCT05994209 - Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors Phase 1
Completed NCT03302026 - Real Time fMRI and Quitting Smoking N/A