Neural Mechanisms Associated With Risk of Smoking Relapse

NCT02837510 | Completed Results

• 2 other identifiers: 8240615R01DA041402
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nicotine Addiction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brain Activation (BOLD Percent Signal Change)

  24 hours

Study Arms (1)

Standard smoking cessation counseling

OTHER

Participants will receive a standard treatment program consisting of smoking cessation counseling.

Behavioral: Standard smoking cessation counseling

Interventions

Standard smoking cessation counseling BEHAVIORAL

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.

Standard smoking cessation counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be:
• Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 5 cigarettes per day for at least the past 6 months;
• Planning to live in the area for at least the next 3 months;
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
• Able to communicate fluently in English (speaking, writing, and reading).

You may not qualify if:

• Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:
• Smoking Behavior:
• Use of chewing tobacco or snuff or cigars;
• Current enrollment or plans to enroll in another smoking cessation program or research study in the next 3 months;
• Current or anticipated (within the next 3 months) use of smoking cessation medications or nicotine replacement therapy (NRT);
• A baseline carbon monoxide (CO) reading less than or equal to 8ppm.
• Alcohol/Drugs:
• Diagnosis or treatment for alcohol or drug abuse in the past two years as reported during phone screen (e.g., alcohol, opioids, cocaine, or stimulants);
• Current alcohol consumption that exceeds 25 standard drinks/week;
• Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake;
• a. Participants testing positive for breath alcohol with a reading equal to or greater than .08 (the legal driving limit) or who are visibly impaired will be instructed not to drive themselves home after the appointment. If a participant needs to use a phone to call for a safe ride home, an office telephone will be made available to the participant.
• A positive urine drug screen for cocaine, opiates, PCP, benzodiazepines, methadone, MDMA, amphetamine, methamphetamine, tri-cyclic antidepressants and/or barbiturates at any session;
• Medication:
• Current use or recent discontinuation (within the past 30 days at the time of Intake) of:
• Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Allenby C, Falcone M, Wileyto EP, Cao W, Bernardo L, Ashare RL, Janes A, Loughead J, Lerman C. Neural cue reactivity during acute abstinence predicts short-term smoking relapse. Addict Biol. 2020 Mar;25(2):e12733. doi: 10.1111/adb.12733. Epub 2019 Feb 25.

  PMID: 30806013 DERIVED

Related Links

• Click here for more information about this study: Neural mechanisms associated with risk of smoking relapse

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: James Loughead PhD
• Organization: University of Pennsylvaina

loughead@pennmedicine.upenn.edu

215-746-6827

Study Officials

• James Loughead, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: July 19, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)