60 Participants NeededMy employer runs this trial

Cue-based Treatment + CBT for Smoking Cessation

LF
LH
Overseen ByLauren Hart, MSW, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people quit smoking by comparing two treatments. One group receives Cognitive Behavioral Therapy (CBT), which uses talk therapy to change habits. The other group receives CBT plus a cue-based treatment intervention that manages cravings by exposing participants to smoking-related triggers and teaching coping strategies. The researchers aim to determine which approach is more effective and acceptable for people who smoke lightly or infrequently. Ideal participants smoke 1-10 cigarettes a day on at least 4 days a week for the past year, are willing to quit in the next 30 days, and have a cell phone for texting. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could help develop new strategies for quitting smoking.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research on treatments using cues to help people stop smoking showed mixed results. One initial study found this approach could work and be acceptable for light smokers. However, another study found that exposure to smoking cues might increase the chance of relapse for those more addicted to nicotine.

Studies have shown that Cognitive Behavioral Therapy (CBT) is a safe and effective way to help people quit smoking. Many studies have demonstrated that CBT can greatly improve the chances of successfully quitting smoking.

While cue-based treatments have shown some promise, the mixed results from past research should be considered. In contrast, CBT has consistently proven safe and effective for quitting smoking.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Cognitive Behavioral Therapy (CBT) and cue-based treatment for smoking cessation because it uniquely integrates exposure to smoking-related cues alongside traditional CBT methods. While most existing treatments for smoking cessation, like nicotine replacement therapies and medications such as varenicline, focus on reducing withdrawal symptoms, this approach directly addresses the environmental and psychological triggers that lead to smoking. By teaching coping strategies in response to these cues, this method could not only help in quitting smoking but also aid in long-term relapse prevention. The use of telehealth for CBT delivery also adds convenience, making it more accessible for participants.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that treatments using smoking-related cues, such as being around reminders of smoking, can help people quit by reducing cravings over time. One study found that cravings decreased steadily during sessions with this type of therapy. Another review found that online programs, which can include these cue-based treatments, significantly help people quit smoking after six months. In this trial, participants will receive either Cognitive Behavioral Therapy (CBT) alone or a combination of CBT and cue-based treatment. CBT has proven effective for quitting smoking, with notable improvements in long-term success rates. Combining CBT with cue-based treatments might enhance these effects by addressing both the mental and trigger-related aspects of smoking habits.678910

Who Is on the Research Team?

LF

Laura Fish

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who smoke lightly (1-10 cigarettes/day on at least 4 days in the past two weeks), have smoked this way for a year, can read English or Spanish, are willing to try quitting in the next month, and have a cell phone with texting.

Inclusion Criteria

* Able to read and understand English or Spanish
* Access to cell phone with texting capabilities
* Smoke 1-10 cigarettes/day on at least 4 days of the past two weeks for the last year
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBT only or CBT + cue-based treatment via telehealth sessions and supportive text messages

12 months
Remote sessions and text-based assessments

Follow-up

Participants are monitored for smoking cessation and cue reactivity

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Cue-based treatment intervention

Trial Overview

The study compares standard Cognitive Behavioral Therapy (CBT) for quitting smoking versus CBT plus an extra cue-based treatment. Both are delivered remotely. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CBT + Cue-based treatmentExperimental Treatment2 Interventions
Group II: CBT onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

University of Oklahoma

Collaborator

Trials
484
Recruited
95,900+

Citations

EVALUATION OF A HOSPITAL-BASED TOBACCO ... - PMC

Six-month follow-up (response rate, 46%) found a 7-day abstinence rate of 32% among respondents for an intent-to-treat abstinence rate of 15%.

The Effectiveness of Cognitive Behavioral Therapy for ...

Results indicate that CBT significantly improves long-term cessation rates. CBT demonstrated greater effectiveness among patients with smoking- ...

Tobacco Use: Internet-based Interventions to Increase ...

Systematic review evidence showed meaningful improvements in tobacco cessation outcomes when measured six or more months following intervention.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24078760/

Decline in cue-provoked craving during cue exposure therapy ...

Results: Mixed-model analyses revealed a progressive decline in cue-provoked craving both within and across 6 sessions of CET. Moderator ...

Effectiveness of smoking-cessation interventions for urban ...

The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost- ...

Cue-Restricted Smoking as a behavioral adjunct for ...

74% of participants in the control group who received CRS with varenicline achieved continuous abstinence from weeks 8 to 12, mirroring ...

Cue-based treatment for light smokers: A proof of concept pilot

Results from this proof-of-concept study demonstrated that a cue-based intervention is feasible and acceptable among light smokers and suggests ...

A randomized clinical trial of cue exposure treatment ...

Results showed that CET is not an effective strategy for smoking cessation. • CET may increase risk of relapse among nicotine-dependent individuals who achieve ...

Cue-reactivity targeted smoking cessation intervention in ...

In this article, we present a scoping review, as being a precursor to systematic reviews, to explore more consistent findings and gaps in current research, to ...

Evidence-based Cessation Treatment

Cessation success is increased by the use of evidence-based treatment, including the use of behavioral counseling and medications. The combination of behavioral ...