Withdrawal Regulation Training for Smoking Cessation

Overseen By Peter S Hendricks, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Alabama at Birmingham

Must not be taking: Smoking cessation drugs

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

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well different strategies help people quit smoking by managing withdrawal symptoms. Participants will use cognitive-behavioral techniques, known as Cognitive-behavioral Withdrawal Regulation Strategies, to ease withdrawal or practice relaxation methods during the initial hours of quitting. The study will identify which approach most effectively helps people quit smoking permanently. It suits current smokers who smoke at least five times a day, want to quit, and live in the Birmingham area. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for smoking cessation.

Will I have to stop taking my current medications?

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

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

Research has shown that strategies to manage withdrawal symptoms can aid in quitting smoking. In a previous study, participants found it easier to control their withdrawal symptoms, increasing their chances of remaining smoke-free.

Another study examined addressing withdrawal symptoms early in the quitting process. This approach might help individuals stick to their decision to quit. Notably, the studies reported no major safety concerns with these methods.

Since this trial is in phase 3, earlier research stages have already established the treatment's safety. Overall, these treatments focus on managing withdrawal symptoms and have not shown any serious side effects in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative strategies to help people quit smoking by focusing on managing withdrawal symptoms more effectively. Traditional smoking cessation treatments often rely on nicotine replacement therapy or medications like bupropion and varenicline, which primarily target nicotine cravings. In contrast, this trial evaluates cognitive-behavioral approaches that train individuals in personalized strategies to regulate withdrawal symptoms, potentially offering a non-pharmacological alternative. By incorporating early withdrawal exposure and relaxation techniques, the study aims to teach smokers how to better handle the initial challenging hours of quitting, which could lead to higher success rates in cessation efforts.

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

Research has shown that certain strategies can help manage withdrawal symptoms and increase the chances of quitting smoking. In this trial, participants will join different treatment arms to test these strategies. One arm will focus on NAW Regulation Training, which involves developing and practicing individualized withdrawal regulation strategies. Another arm will combine Early Withdrawal Exposure with NAW Regulation Training, while a separate arm will combine Early Withdrawal Exposure with Relaxation Control Training. Lastly, one arm will focus solely on Relaxation Control Training. In one study, these strategies doubled the success rate compared to usual methods, meaning participants using these strategies were twice as likely to stop smoking for at least a week. Additionally, facing withdrawal symptoms early on might improve long-term success, especially when combined with other methods. Overall, both approaches focus on managing withdrawal to help people quit smoking. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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

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

Expired breath carbon monoxide (CO) reading of at least five parts per million

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.

I am currently in a program to help me stop smoking.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-behavioral Withdrawal Regulation Strategies
• Early Withdrawal Exposure
• Relaxation Strategies

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Nicotine replacement therapies (like patches and gum) are effective for helping smokers quit, with success rates of 30-40%, and their efficacy increases when multiple forms are combined.

Non-drug methods such as hypnosis and acupuncture have not been shown to be effective for smoking cessation, while bupropion shows promise but requires further study due to potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of nicotine dependence. Haustein, KO.[2019]

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 bias modification (CBM) significantly increased the likelihood of abstaining from alcohol in patients after inpatient withdrawal treatment, with abstinence rates of 54.4% in the CBM group compared to 42.5% in the control group, indicating an 11.9% improvement.

CBM is a safe and easy-to-implement intervention that could be routinely used during withdrawal treatment, as it requires minimal resources and no specialized training, making it a practical adjunct to enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial. Manning, V., Garfield, JBB., Staiger, PK., et al.[2022]

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]

A smoking program that provided education and optional treatment for smoking was well-received by both chemical dependency clients and staff at an addiction treatment center, indicating a positive attitude towards integrating smoking cessation into substance abuse treatment.

Of the clients who chose to participate in the smoking program, 17.5% achieved abstinence at follow-up, demonstrating that even optional smoking cessation efforts can lead to successful outcomes among those in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding a choice-based program for tobacco smoking to an abstinence-based addiction treatment program. Bernstein, SM., Stoduto, G.[2022]

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]

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]

In a study of 567 smokers, the nicotine patch significantly increased smoking cessation rates compared to a placebo, with continuous abstinence rates of 19.4% for the nicotine patch versus 7.0% for placebo at 6 weeks.

The nicotine patch was found to be safe, with only mild adverse events reported, and effective for smoking cessation over a 10-week period, even without direct behavioral support or counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of over-the-counter nicotine patch. Shiffman, S., Gorsline, J., Gorodetzky, CW.[2017]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0376871616300497

Withdrawal exposure with withdrawal regulation training for ... In-session withdrawal ratings suggested WT improved regulation of withdrawal symptoms, which were in turn associated with abstinence.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI In a separate study, Webb Hooper and colleagues (2017) found that culturally specific CBT resulted in double the 7-day point-prevalence cessation rate compared ...

3. withpower.com withpower.com/trial/phase-3-tobacco-use-disorder-7-2019-2deb1

Withdrawal Regulation Training for Smoking Cessation Trial Overview The study tests new ways to help people stop smoking by teaching them cognitive-behavioral strategies for managing withdrawal symptoms and ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03912194/early-withdrawal-exposure-and-negative-affect-withdrawal-naw-regulation-training-for-smoking-cessation

Early Withdrawal Exposure and Negative Affect ... The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking ...

5. clinicaltrial.be clinicaltrial.be/en/details/64241?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Early Withdrawal Exposure and Negative Affect ... The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03948893

Smoking Cessation Behavioral Treatment Study The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4119230/

Extended cognitive behavior therapy for cigarette smoking ... The fact that 45% met abstinence criteria at end of extended CBT is encouraging and suggests, along with results from previous extended treatment trials [8,9], ...