Episodic Future Thinking and Future Thinking Priming for Smoking Cessation

Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking

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.

Study Overview

• Status: Terminated
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Other: Informational Intervention; Other: Telephone-Based Intervention; Drug: Nicotine Replacement

Detailed Description

PRIMARY OBJECTIVE:

I. To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.

OUTLINE: Participants are randomized to 1 of 4 arms.

ARM I: 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.

ARM II: 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.

ARM III: 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.

ARM IV: 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (active EFT, active FTP); 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; Complete active episodic thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete active future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control episodic future thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Other: Informational Intervention; Provided with Forever Free relapse prevention booklet; Other: Telephone-Based Intervention; Receive coaching call
Experimental: Arm II (active EFT, control FTP); 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; Complete active episodic thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete active future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control episodic future thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Other: Informational Intervention; Provided with Forever Free relapse prevention booklet; Other: Telephone-Based Intervention; Receive coaching call; Drug: Nicotine Replacement; Receive nicotine patches, gum, or lozenges; Other Names: NRT; nicotine replacement therapy
Experimental: Arm III (control EFT, active FTP); 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; Complete active episodic thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete active future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control episodic future thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Other: Informational Intervention; Provided with Forever Free relapse prevention booklet; Other: Telephone-Based Intervention; Receive coaching call; Drug: Nicotine Replacement; Receive nicotine patches, gum, or lozenges; Other Names: NRT; nicotine replacement therapy
Active Comparator: Arm IV (control EFT, control TFP); 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; Complete active episodic thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete active future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control episodic future thinking task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Behavioral: Behavioral Intervention; Complete control future thinking priming task; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Other: Informational Intervention; Provided with Forever Free relapse prevention booklet; Other: Telephone-Based Intervention; Receive coaching call; Drug: Nicotine Replacement; Receive nicotine patches, gum, or lozenges; Other Names: NRT; nicotine replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency to first relapse	Defined as the number of days until first relapse (any smoking for seven consecutive days). Will be assessed with the Timeline Follow-Back procedure administered by telephone. Analyzed using generalized mixed models.	up to 12 weeks
Number of days abstinent	Will be evaluated by cox proportional-hazards survival model analyses.	Up to 12 weeks
7-day point prevalence abstinence rates	Will be evaluated by cox proportional-hazards survival model analyses.	At 4 and 12 weeks after quit date
Attentional, motor, and non-planning impulsiveness	Assessed with the Barratt Impulsiveness Scale.	Up to 12 weeks
Behavioral inhibition and behavioral activation	Assessed with the Behavioral Avoidance/Inhibition scales.	Up to 12 weeks
Self-control	Assessed with the Brief Self-Control Survey.	Up to 12 weeks
Ability to regulate behavior to achieve goals	Assessed with the Short Self-Regulation Questionnaire.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Christine Sheffer, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: I 82819 (Other Identifier: Roswell Park Cancer Institute); NCI-2020-00697 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No