Neural Mechanisms Associated With Risk of Smoking Relapse
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|ClinicalTrials.gov Identifier: NCT02837510|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Addiction||Behavioral: Standard smoking cessation counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neural Mechanisms Associated With Risk of Smoking Relapse|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Standard smoking cessation counseling
Participants will receive a standard treatment program consisting of smoking cessation counseling.
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.
- Days to relapse [ Time Frame: 6 months after target quit date ]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.
- Mood [ Time Frame: Target Quit Date through 6-month follow-up ]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
- Nicotine withdrawal [ Time Frame: Target Quit Date through 6-month follow-up ]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.
- Smoking Urges/Craving [ Time Frame: Target Quit Date through 6-month follow-up ]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).
- Stress/Anxiety [ Time Frame: 1-2 weeks following intake session ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837510
|Contact: Mary Falcone, Ph.D.||email@example.com|
|Contact: Leah Bernardo, B.A.||firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Mary Falcone, Ph.D. 215-746-3782 email@example.com|
|Contact: Leah Bernardo, B.A. 215-746-7162 firstname.lastname@example.org|
|Sub-Investigator: Caryn Lerman, Ph.D.|
|Principal Investigator: James Loughead, Ph.D.|
|Sub-Investigator: Rebecca Ashare, Ph.D.|
|Sub-Investigator: Taki Shinohara, Ph.D.|
|Sub-Investigator: John Detre, M.D.|
|Principal Investigator:||James Loughead, Ph.D.||University of Pennsylvania|