Withdrawal Regulation Training for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Smoking cessation drugs

Disqualifiers: Life-threatening disease, Nicotine patch contraindication, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.

Will I have to stop taking my current medications?

The trial requires that you are not currently using any medications for smoking cessation.

What data supports the effectiveness of the treatment Cognitive-behavioral Withdrawal Regulation Strategies for smoking cessation?

The study on withdrawal exposure with withdrawal regulation training suggests that addressing withdrawal processes can be a key motivational factor in smoking cessation, indicating potential effectiveness of cognitive-behavioral strategies in reducing withdrawal severity. ^{1 2 3 4 5}

Is Withdrawal Regulation Training for Smoking Cessation safe for humans?

The safety of Withdrawal Regulation Training for Smoking Cessation, which includes techniques like Cognitive-behavioral strategies, Relaxation, and Mindfulness-Based Interventions, is generally supported by research on similar behavioral treatments. These methods are non-invasive and typically considered safe for human use. ^{6 7 8 9 10}

How is the treatment 'Cognitive-behavioral Withdrawal Regulation Strategies, Early Withdrawal Exposure' different from other smoking cessation treatments?

This treatment is unique because it focuses on training individuals to manage withdrawal symptoms through cognitive-behavioral strategies, rather than relying solely on nicotine replacement or gradual withdrawal. It emphasizes understanding and regulating withdrawal processes, which are key motivational factors in smoking, to help reduce withdrawal severity and improve cessation outcomes. ^{1 4 11 12 13}

Research Team

Eligibility Criteria

This trial is for adults over 18 who smoke at least 5 cigarettes a day, want to quit, and live in the Birmingham area without plans to move. They must have access to a phone and show certain levels of carbon monoxide in their breath. People using other quit-smoking drugs or treatments, with conditions that make quitting harder or riskier, or with serious health issues can't join.

Inclusion Criteria

access to a telephone

I am 18 years old or older.

reside in the Birmingham area with no plan to relocate outside of the area in the next 6 months

Exclusion Criteria

I am currently using medication to help me stop smoking.

I don't have any health issues that would make following the study rules hard.

You cannot speak or understand English.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo early withdrawal exposure and NAW regulation training or relaxation control training over 4 separate sessions

4 weeks

4 sessions

Follow-up

Participants are monitored for smoking cessation outcomes and withdrawal symptoms

6 months

Treatment Details

Interventions

• Cognitive-behavioral Withdrawal Regulation Strategies (Behavioral Intervention)
• Early Withdrawal Exposure (Behavioral Intervention)
• Relaxation Strategies (Behavioral Intervention)

Trial Overview The study tests new ways to help people stop smoking by teaching them cognitive-behavioral strategies for managing withdrawal symptoms and exposing them early on to these symptoms. It also includes relaxation techniques as part of the intervention.

Participant Groups

Group I: Early Withdrawal Exposure plus NAW Regulation Training Experimental Treatment 2 Interventions

The development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) across the first 4 hours of abstinence over 4 separate sessions.

Group II: NAW Regulation Training Only Active Control 1 Intervention

The development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) over 4 separate sessions involving smoking as usual.

Group III: Early Withdrawal Exposure plus Relaxation Control Training Active Control 2 Interventions

The development, application, modification, and repeated practice of relaxation strategies across the first 4 hours of abstinence over 4 separate sessions.

Group IV: Relaxation Control Training Only Active Control 1 Intervention

The development, application, modification, and repeated practice of relaxation strategies over 4 separate sessions involving smoking as usual.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

A pilot study involving 80 adult smokers found that a smoking cessation intervention combining withdrawal exposure with withdrawal regulation training (WT) led to a higher abstinence rate (22.2%) compared to a relaxation control group (0% at Month 2 and 4.2% at Month 3).

The WT group reported better regulation of withdrawal symptoms during sessions, suggesting that improving withdrawal management may enhance the chances of quitting smoking, indicating a need for further research into this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Withdrawal exposure with withdrawal regulation training for smoking cessation: a randomized controlled pilot trial. Hendricks, PS., Hall, SM., Tyus, LR., et al.[2020]

A high-intensity cognitive-behavioral intervention for smokers during hospital stays significantly increased smoking cessation rates at 12 months, with 27% of participants quitting compared to only 7% of those who declined to participate.

Adding nicotine replacement therapy (NRT) to the cognitive intervention further improved quitting rates, with 33% of participants who received both therapies stopping smoking, compared to 21% who only received behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients. Ortega, F., Vellisco, A., Márquez, E., et al.[2018]

In a study of 1,895 hospitalized smokers, 62% received nicotine replacement therapy (NRT) during their stay, and 42% of those surveyed reported using NRT within 2 weeks after discharge.

Smokers who used NRT while hospitalized were significantly more likely to continue using it after discharge, with adjusted rate ratios indicating a strong association between in-hospital NRT use and postdischarge initiation, suggesting that NRT can effectively support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy use at home after use during a hospitalization. Regan, S., Reyen, M., Richards, AE., et al.[2021]

A study involving 111 patients compared the effectiveness of gradual nicotine withdrawal without nicotine replacement therapy (NRT) to NRT for smoking cessation, showing no significant difference in success rates after one year (65.3% for NRT vs. 51.8% for gradual withdrawal) or over a three-year follow-up (41% for NRT vs. 36% for gradual withdrawal).

Both methods demonstrated similar effectiveness in helping patients quit smoking, suggesting that gradual nicotine withdrawal can be a viable alternative to NRT in smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy versus gradual smoking withdrawal in smoking cessation]. Marcos, T., Godás, T., Corominas, J.[2019]

In a 6-week study involving 60 participants, the non-pharmacologic nicotine-blocking agent (Accu Drop) combined with counseling did not lead to higher smoking cessation rates compared to the placebo group, with both groups showing similar abstinence rates at follow-ups.

Despite the high nicotine dependence of participants, neither treatment group showed significant differences in treatment completion or withdrawal symptoms, indicating that the non-pharmacologic approach may not be effective enough to warrant further large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding a nicotine blocking agent to cigarette tapering. Gariti, P., Alterman, AI., Lynch, KG., et al.[2007]

Nicotine replacement therapy (NRT) and bupropion are both safe and effective options for helping smokers quit, with benefits seen in both short and long-term cessation rates.

All patients willing to quit smoking, except those with minimal dependence, should be offered NRT or bupropion, especially when combined with counseling, although NRT is not recommended during pregnancy or for patients with certain heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacotherapy of smoking cessation. Peters, MJ., Morgan, LC.[2020]

Cognitive-behavioral strategies are effective for helping smokers quit by addressing the emotional and situational triggers associated with smoking, based on social learning theory.

Health workers can support quitting smokers by teaching techniques to manage cravings, enhance motivation, and develop coping strategies, which are crucial for overcoming withdrawal symptoms and maintaining abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping patients to stop smoking. Slama, K., Chiang, CY., Enarson, DA.[2007]

A large randomized-controlled trial is being conducted with 1,410 participants to test the effectiveness of using nicotine-free cigarettes alongside nicotine replacement therapy (NRT) in improving long-term quit rates for smokers.

The study aims to address both nicotine and psychological dependence on cigarettes, which could provide a new strategy for smoking cessation, especially important given the stagnant smoking rates in New Zealand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking. Walker, NK., Howe, C., Bullen, C., et al.[2021]

In a study involving 1,199 adults in Brazil, nicotine replacement therapy (NRT) significantly increased smoking cessation rates, with abstinence proportions reaching up to 34% for those receiving NRT compared to 20% for those not receiving it.

The results indicated a 'dose-response' effect, where more intensive cognitive-behavioral counseling sessions combined with NRT led to higher rates of abstinence, suggesting that both approaches are effective for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Randomized clinical trial: effectiveness of the cognitive-behavioral approach and the use of nicotine replacement transdermal patches for smoking cessation among adults in Rio de Janeiro, Brazil]. Otero, UB., Perez, Cde A., Szklo, M., et al.[2022]

References

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

Withdrawal exposure with withdrawal regulation training for smoking cessation: a randomized controlled pilot trial. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapy use at home after use during a hospitalization. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy versus gradual smoking withdrawal in smoking cessation]. [2019]

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

Adding a nicotine blocking agent to cigarette tapering. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of over-the-counter nicotine patch. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of nicotine dependence. [2019]

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

Adding a choice-based program for tobacco smoking to an abstinence-based addiction treatment program. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

The pharmacotherapy of smoking cessation. [2020]

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

Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Helping patients to stop smoking. [2007]

12. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking. [2021]

13. Brazil pubmed.ncbi.nlm.nih.gov

[Randomized clinical trial: effectiveness of the cognitive-behavioral approach and the use of nicotine replacement transdermal patches for smoking cessation among adults in Rio de Janeiro, Brazil]. [2022]