Episodic Future Thinking and Future Thinking Priming for Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Promising Methods to Decrease Delay Discounting and Reduce Relapse to Smoking

Conditions
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Tobacco-Related Carcinoma

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Behavioral: Behavioral Intervention
* Other: Informational Intervention
* Drug: Nicotine Replacement
* Other: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (active EFT, active FTP)<br>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<br>* Complete active episodic thinking task<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Complete active future thinking priming task<br>* Other names: Behavioral Treatments;Other: Informational Intervention<br>* Provided with Forever Free relapse prevention booklet<br>Other: Telephone-Based Intervention<br>* Receive coaching call<br>|
| Experimental: Arm II (active EFT, control FTP)<br>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<br>* Complete active episodic thinking task<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Complete control future thinking priming task<br>* Other names: Behavioral Treatments;Other: Informational Intervention<br>* Provided with Forever Free relapse prevention booklet<br>Drug: Nicotine Replacement<br>* Receive nicotine patches, gum, or lozenges<br>* Other names: NRT;Other: Telephone-Based Intervention<br>* Receive coaching call<br>|
| Experimental: Arm III (control EFT, active FTP)<br>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<br>* Complete active future thinking priming task<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Complete control episodic future thinking task<br>* Other names: Behavioral Treatments;Other: Informational Intervention<br>* Provided with Forever Free relapse prevention booklet<br>Drug: Nicotine Replacement<br>* Receive nicotine patches, gum, or lozenges<br>* Other names: NRT;Other: Telephone-Based Intervention<br>* Receive coaching call<br>|
| Active Comparator: Arm IV (control EFT, control TFP)<br>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<br>* Complete control episodic future thinking task<br>* Other names: Behavioral Treatments;Behavioral: Behavioral Intervention<br>* Complete control future thinking priming task<br>* Other names: Behavioral Treatments;Other: Informational Intervention<br>* Provided with Forever Free relapse prevention booklet<br>Drug: Nicotine Replacement<br>* Receive nicotine patches, gum, or lozenges<br>* Other names: NRT;Other: Telephone-Based Intervention<br>* Receive coaching call<br>|

What is the study measuring?
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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 |