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

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.

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.

What data supports the effectiveness of the treatment Behavioral Activation + Nicotine Patches for Smoking Cessation?

Research shows that combining nicotine replacement therapy, like nicotine patches, with behavioral counseling can improve quit rates for smoking. In one study, smokers who used tailored behavioral support materials along with nicotine patches had higher quit rates compared to those who only used a brief guide and audiotape. ^{1 2 3 4 5}

How is the Behavioral Activation + Nicotine Patches treatment different from other smoking cessation treatments?

This treatment is unique because it combines Behavioral Activation Therapy, which helps manage mood and motivation, with nicotine patches, a form of nicotine replacement therapy. This dual approach addresses both the psychological and physical aspects of quitting smoking, making it particularly beneficial for individuals with depression who find it hard to quit. ^{6 7 8 9 10}

Research Team

Jennifer A. Minnix

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy. [2019]

2. England 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Treating nicotine dependence. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Telephone support as an adjunct to transdermal nicotine in smoking cessation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and bupropion for smoking cessation: a systematic review and multiple treatment meta-analysis. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of the first-line therapies for nicotine dependence. [2018]