Behavioral Activation + Nicotine Patches for Smoking Cessation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Smoking cessation meds, MAOIs, Elavil

Disqualifiers: Uncontrolled hypertension, Seizure disorder, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining behavioral activation therapy with nicotine patches to help people quit smoking. Behavioral activation involves changing reactions to situations that trigger smoking urges. Participants will receive either nicotine patches with smoking cessation strategies or a combination of smoking cessation and behavioral activation techniques. Ideal participants have smoked at least five cigarettes daily in the past two months and are interested in quitting. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to quitting smoking.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are smoking cessation meds or specific depression treatments. The trial excludes those using certain medications like Wellbutrin, bupropion, and some antidepressants within a specified period before joining.

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

Research has shown that behavioral activation therapy for quitting smoking is generally safe. Studies have found it causes no more side effects than other common smoking cessation methods, allowing most people to use it without issues.

The nicotine patch, a well-studied and popular aid for quitting smoking, can help reduce cravings and withdrawal symptoms. Some individuals might experience side effects such as nausea, skin irritation at the patch site, and, in rare cases, heart palpitations or chest pain.

Both treatments have been safely used by many. It is important to consult a healthcare provider with any concerns or questions about trying them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine Behavioral Activation Therapy with nicotine patches to tackle smoking cessation in a fresh way. Unlike traditional options like nicotine replacement therapies (NRT) and counseling alone, Behavioral Activation Therapy focuses on helping individuals engage in rewarding activities that can distract from smoking urges, providing a unique psychological approach. By pairing this with the proven effectiveness of nicotine patches, there's potential for more comprehensive support in quitting smoking. This dual approach could enhance motivation and reduce relapse rates, offering hope for those struggling to quit.

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

Research has shown that behavioral activation therapy can help people quit smoking. In this trial, participants in Group II will receive behavioral activation therapy combined with nicotine replacement therapy (NRT), such as nicotine patches, which increases the chances of successfully quitting. Those who have used this approach reported success in stopping smoking and reducing their smoking habits.

Participants in Group I will receive nicotine patches along with standard smoking cessation strategies. Nicotine patches have proven effective, with studies indicating that people using them are more than twice as likely to quit smoking compared to those using a placebo patch. Combining behavioral activation with nicotine patches may provide a strong method to help people stop smoking. ^{2 6 7 8 9}

Who Is on the Research Team?

Jennifer A. Minnix

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, want to quit or change their smoking habits, and can follow instructions in English. They must be the only participant from their household and have contact details. People with uncontrolled high blood pressure, certain neurological conditions, or using specific medications cannot join. Pregnant women or those not using effective birth control are also excluded.

Inclusion Criteria

Be the only participant in their household

Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)

Able to follow verbal and written instructions in English and complete all aspects of the study

Exclusion Criteria

I have not been hospitalized for psychiatric reasons in the last year.

I plan to use nicotine substitutes or smoking cessation treatments soon.

I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NRT patch daily and behavioral treatment sessions for 8 weeks

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for smoking cessation effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation Therapy
• Nicotine Patch

Trial Overview The study tests whether combining behavioral activation therapy (a method that helps people react differently to triggers) with nicotine patches helps smokers quit or modify their behavior more effectively than other methods.

How Is the Trial Designed?

Group I: Group I (NRT, SC) Active Control 4 Interventions

Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.

Group II: Group II (NRT, BATS) Active Control 4 Interventions

Patients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Actify! mobile health app, designed for depressed smokers, showed good acceptability with participants logging in an average of 16.6 times and 63% reporting overall satisfaction, indicating its potential as a widely accessible intervention.

Participants experienced a significant reduction in depressive symptoms and a 31% rate of carbon monoxide-verified smoking abstinence at 6 weeks, suggesting that the app may effectively support both mental health and smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial. Heffner, JL., Watson, NL., Serfozo, E., et al.[2020]

The Committed Quitters Program (CQP) significantly improved quit rates among smokers who actively used the program materials, with 38.8% abstinence at 6 weeks and 18.2% at 12 weeks, compared to 30.7% and 11.1% in the standard User's Guide (UG) group.

Overall abstinence rates did not differ significantly between the CQP and UG groups, indicating that the effectiveness of CQP is particularly notable among those who engage with the tailored materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. Shiffman, S., Paty, JA., Rohay, JM., et al.[2019]

In a study of 737 smokers, varenicline (VR) was found to be more effective than standard nicotine replacement therapy (NRT) in achieving smoking abstinence, particularly in the medium term, with higher continuous abstinence rates at weeks 5-22 and 52.

Both varenicline and extended use of combined nicotine replacement therapy (NRT+) showed significant improvements in early quitting success compared to NRT alone, although long-term quit rates did not differ significantly between these treatments and NRT monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial. Tulloch, HE., Pipe, AL., Els, C., et al.[2018]

In a study involving 2,054 smokers from a Veterans Affairs Medical Center, various smoking cessation interventions were tested over 30 months, showing that stage-matched manuals alone achieved a cessation rate of 20.3%.

Adding nicotine replacement therapy (NRT) and other expert or automated counseling methods did not significantly improve cessation rates compared to the manuals alone, indicating that the effectiveness of these additional interventions may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. Velicer, WF., Friedman, RH., Fava, JL., et al.[2019]

The study involved 509 participants and assessed the effectiveness of telephone support alongside a single-session group orientation smoking cessation program with nicotine patches, but found no significant differences in abstinence rates between groups.

Overall, the smoking cessation program achieved a 22% abstinence rate at 6 months and 21% at 1 year, indicating that while the program was effective, additional telephone support did not enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone support as an adjunct to transdermal nicotine in smoking cessation. Lando, HA., Rolnick, S., Klevan, D., et al.[2019]

The study involved 275 adult smokers and compared a smoking cessation treatment that included behavioral activation (SCBSCT-BA) with a standard cognitive-behavioral treatment (SCBSCT) and a wait-list control group, showing that SCBSCT-BA led to higher smoking abstinence rates at 12 months (30% vs. 18%).

Participants in the SCBSCT-BA group not only had better smoking cessation outcomes but also experienced significant reductions in depressive symptoms, highlighting the effectiveness of integrating behavioral activation into smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. Martínez-Vispo, C., Rodríguez-Cano, R., López-Durán, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37910157/

Behavioral Activation-Based Digital Smoking Cessation ... A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation.

2. jmir.org jmir.org/2023/1/e49809/

Behavioral Activation–Based Digital Smoking Cessation ... A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01199380

Behavioral Activation Intervention for Smoking Cessation in ... This will be a Stage II randomized control trial to examine the efficacy of behavioral activation treatment for smoking (BATS) vs. standard smoking cessation ...

4. fredhutch.org fredhutch.org/en/news/spotlight/2024/07/reduce-smoking-rates-with-a-behavioral-activation-mhealth-app--a.html

Reduce smoking rates with a behavioral activation ... Integrating evidence-based depression treatment into a mobile health app significantly improves smoking cessation rates.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722916300086

Development of a Behavioral Activation–Based ... Most pilot study participants exhibited smoking abstinence and smoking reductions at the end of treatment, as well as improvement in depressive symptoms and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11663802/

Behavioral Activation mHealth Application for Smoking ... This study preliminarily evaluated the acceptability and efficacy of the BA-based Actify! mobile health application (mHealth app) for smoking cessation.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16209

Efficacy and safety of combination behavioral activation for ... Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy.

8. academic.oup.com academic.oup.com/ntr/article/27/9/1524/8071410

Behavioral Activation for Smoking Cessation in Veterans with ... Behavioral activation therapy did not produce higher smoking abstinence rates than an attention-contact control therapy when each was paired with standard ...

9. formative.jmir.org formative.jmir.org/2024/1/e54912

Behavioral Activation Mobile App to Motivate Smokers to Quit The results demonstrated that it is feasible to recruit smokers who are unmotivated to quit into a smoking cessation induction trial: 86% (57/66) ...