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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02837510
Other study ID # 824061
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date October 31, 2024

Study information

Verified date December 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine how abstinence-induced brain changes contribute to smoking cessation outcomes in treatment-seeking smokers.


Description:

Smoking is the greatest preventable cause of mortality and a significant economic burden. Even with the best available treatments, most smokers relapse within days or weeks after a quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end of treatment quit rates of <25% suggesting that managing nicotine withdrawal is not sufficient. To improve quit rates significantly, a more refined mechanistic understanding is needed. Neuroimaging can identify mechanisms underlying behavior change beyond self-report and behavioral measures. Functional magnetic resonance imaging (fMRI) studies show that brief (e.g., 24 hr.) abstinence from smoking produces working memory deficits associated with reduced neural activity in cognitive control circuits and weakened resting state functional connectivity. Neural reactivity to smoking cues also increases risk of relapse, and psychological stress can enhance neural responses to smoking cues and increase smoking intensity. This study will examine how abstinence-induced brain changes contribute to clinical outcomes in treatment-seeking smokers. Using a validated fMRI abstinence challenge paradigm, 200 treatment-seeking smokers will complete two 1-hour pre-treatment fMRI scans: after smoking satiety and after 24 hours of confirmed abstinence. The investigators will examine brain responses during performance of tasks probing working memory, cue reactivity, and stress response as well as resting state functional connectivity. Participants will then set a target quit date, receive smoking cessation counseling, and be monitored for 6 months to assess time to relapse using a validated smoking relapse protocol.


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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard smoking cessation counseling
Participants will discuss reasons for quitting, the model of smoking as a learned habit, triggers for smoking, and trigger management; receive brief training in how to manage withdrawal symptoms and relapse prevention counseling and receive the NCI Clearing the Air self-help smoking cessation booklet. The target quit date (TQD) session will be scheduled to occur up to 2 weeks following the pre-quit session. Participants will then meet with a smoking cessation counselor for a 15 minute booster counseling session. During the first week following TQD there will be two monitoring visits to closely monitor abstinence. Weekly thereafter for four weeks, participants will attend a brief booster counseling session.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Days to relapse The primary outcome will be the number of days to relapse following the target quit date. Relapse will be confirmed using a conventional SRNT guideline criterion of either a positive biochemical verification of smoking or 7 consecutive days of smoking based on self-report (it is very unlikely that a subject would meet the latter criterion without also meeting the former, given the long half-life of cotinine). The days to relapse will be based upon time from target quit date to the first day of the relapse period. Self-reported daily smoking data will be collected using a validated timeline follow-back method. Self-reported abstinence will be biochemically verified on a weekly basis using urine cotinine (<100ng/ml) and a CO reading of =5PPM. Drop-outs will be considered relapsers following the last date of abstinence data provided. 6 months after target quit date
Secondary Mood The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, will be used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. This measure will be administered at all study visits Target Quit Date through 6-month follow-up
Secondary Nicotine withdrawal The Revised Minnesota Nicotine Withdrawal Scale (MNWS-R) is a fifteen-item self-report measure where participants rate their feelings of withdrawal on a scale of 0 (none) to 4 (severe). This measure will be administered at all study visits. Target Quit Date through 6-month follow-up
Secondary Smoking Urges/Craving The 10-item brief QSU-B questionnaire on smoking urges will be administered at the same time points to assess cravings to smoke. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect). Target Quit Date through 6-month follow-up
Secondary Stress/Anxiety Anxiety will be measured at intake and at both fMRI scanning sessions using the State-Trait Anxiety Index, which has been used as a covariate in fMRI studies of stress response. 1-2 weeks following intake session
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