Episodic Future Thinking and Future Thinking Priming for Smoking Cessation

NCT04297332 | Terminated

• 2 other identifiers: I 82819NCI-2020-00697
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Delay discounting rate

  Assessed with the 5-Trial Adjusting Delay Discounting.

  Baseline, and 4 and 12 weeks after quit date

• Latency to relapse

  Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.

  Baseline, assessed up to 12 weeks

Secondary Outcomes (7)

• Latency to first relapse

  up to 12 weeks

• Number of days abstinent

  Up to 12 weeks

• 7-day point prevalence abstinence rates

  At 4 and 12 weeks after quit date

• Attentional, motor, and non-planning impulsiveness

  Up to 12 weeks

• Behavioral inhibition and behavioral activation

  Up to 12 weeks

Study Arms (4)

Arm I (active EFT, active FTP)

EXPERIMENTAL

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

Behavioral: Behavioral Intervention; Other: Informational Intervention; Other: Telephone-Based Intervention

Arm II (active EFT, control FTP)

EXPERIMENTAL

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention

Arm III (control EFT, active FTP)

EXPERIMENTAL

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention

Arm IV (control EFT, control TFP)

ACTIVE COMPARATOR

Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

Behavioral: Behavioral Intervention; Other: Informational Intervention; Drug: Nicotine Replacement; Other: Telephone-Based Intervention

Interventions

Behavioral Intervention BEHAVIORAL

Complete active episodic thinking task

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Arm I (active EFT, active FTP); Arm II (active EFT, control FTP)

Informational Intervention OTHER

Provided with Forever Free relapse prevention booklet

Arm I (active EFT, active FTP); Arm II (active EFT, control FTP); Arm III (control EFT, active FTP); Arm IV (control EFT, control TFP)

Nicotine Replacement DRUG

Receive nicotine patches, gum, or lozenges

Also known as: nicotine replacement therapy, NRT

Arm II (active EFT, control FTP); Arm III (control EFT, active FTP); Arm IV (control EFT, control TFP)

Telephone-Based Intervention OTHER

Receive coaching call

Arm I (active EFT, active FTP); Arm II (active EFT, control FTP); Arm III (control EFT, active FTP); Arm IV (control EFT, control TFP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoke \>= 8 cigarettes daily
• Planning to quit in the next 14 days
• No regular use of other tobacco products
• Access to the internet
• In possession of a smartphone with text messaging capabilities
• In possession of an email address accessible at least every other day

You may not qualify if:

• Unable or unwilling to provide consent
• Unable to provide data to the research team after the quit date
• Current use of bupropion or varenicline
• Drinking \>= 20 alcoholic drinks per week
• Use of drugs of abuse in the past 30 days
• Living in the same household as a participant already enrolled in this study

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Behavior Therapy; Nicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics

Study Officials

• Christine Sheffer

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2020
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

US (1)