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Behavioral Intervention for Smoking Cessation

N/A
Waitlist Available
Led By Christine Sheffer
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to quit in the next 14 days
No regular use of other tobacco products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 and 12 weeks after quit date
Awards & highlights

Study Summary

This trial is testing if thinking about the future can help people quit smoking. They will do this by looking at how well people do when asked to think about the future and if this helps them resist smoking.

Who is the study for?
This trial is for individuals who smoke at least 8 cigarettes daily, are planning to quit in the next two weeks, have internet access and a smartphone with texting. They should not use other tobacco products or heavy alcohol, nor be on certain smoking cessation drugs or abusing substances.Check my eligibility
What is being tested?
The study examines if tasks that make participants think about their future can help them stop smoking. It includes behavioral exercises, nicotine replacements, educational materials, and support over the phone to see which combination works best.See study design
What are the potential side effects?
Since this trial focuses on behavioral strategies rather than medication (except for standard nicotine replacement), side effects may include discomfort from withdrawal symptoms like cravings or irritability when trying to quit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are not planning to stop using the substance being studied in the next 14 days.
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You don't use any tobacco products regularly.
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You have a smartphone that can send and receive text messages.
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You smoke at least 8 cigarettes a day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 and 12 weeks after quit date
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 and 12 weeks after quit date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Delay discounting rate
Latency to relapse
Secondary outcome measures
7-day point prevalence abstinence rates
Ability to regulate behavior to achieve goals
Attentional, motor, and non-planning impulsiveness
+4 more

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896
13%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavioral Intervention & DCS
Behavioral Intervention & Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (control EFT, active FTP)Experimental Treatment4 Interventions
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.
Group II: Arm II (active EFT, control FTP)Experimental Treatment4 Interventions
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.
Group III: Arm I (active EFT, active FTP)Experimental Treatment3 Interventions
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.
Group IV: Arm IV (control EFT, control TFP)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Nicotine Replacement
2019
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,488 Total Patients Enrolled
Christine ShefferPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
426 Total Patients Enrolled

Media Library

Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04297332 — N/A
Tobacco-Related Cancer Research Study Groups: Arm I (active EFT, active FTP), Arm II (active EFT, control FTP), Arm III (control EFT, active FTP), Arm IV (control EFT, control TFP)
Tobacco-Related Cancer Clinical Trial 2023: Behavioral Intervention Highlights & Side Effects. Trial Name: NCT04297332 — N/A
Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04297332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any other research conducted on the effects of Behavioral Intervention?

"Presently, 71 clinical trials are underway to explore Behavioral Intervention. Of those studies, 5 have advanced to Phase 3 and 204 distinct sites are involved in the research. The majority of these locations can be found within Greenville, South carolina."

Answered by AI

How many participants have been recruited into this trial?

"Affirmative, the information on clinicaltrials.gov verifies that this experiment is actively looking for enrollees. It was first put up on May 3rd 2019 and last altered April 29th 2022; 76 volunteers are needed from one medical site."

Answered by AI

Are there any vacancies available in this research program?

"As evidenced on clinicaltrials.gov, the recruitment of participants is ongoing for this medical trial that was publically introduced in May 2019 and recently updated at the end April 2022."

Answered by AI

What objectives does this experiment aim to fulfill?

"This time-bound trial (Baseline to 12 weeks) intends to measure change in the rate of delay discounting. Secondary aims include assessing attentional, motor, and non-planning impulsiveness with Barratt Impulsiveness Scale; Behavioral inhibition/activation via Behavioral Avoidance/Inhibition scales; and number of abstinent days through Cox Proportional Hazards Survival Model Analyses."

Answered by AI
~5 spots leftby Mar 2025