← Back to Search

Withdrawal Regulation Training for Smoking Cessation

Phase 3

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

at least 18 years of age

Be older than 18 years old

Must not have

current use of any pharmacotherapy for smoking cessation

concurrent participation in a formal treatment program for smoking cessation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after end-of-treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test a new smoking cessation treatment to see if it is effective and how it works. The results could help improve existing treatments and reduce smoking-related deaths in the US.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on behavioral strategies rather than medication, there are no direct side effects like those from drugs. However, participants may experience increased stress or anxiety due to withdrawal symptom exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using medication to help me stop smoking.

Select...

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

Select...

I do not have any immediately life-threatening illnesses.

Select...

I have a health issue that prevents me from using nicotine patches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after end-of-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after end-of-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after end-of-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence

Secondary study objectives

Abstinence-related expectancies

Cessation milestones as determined by the Timeline Followback Interview

Smoke

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Early Withdrawal Exposure plus NAW Regulation TrainingExperimental Treatment2 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 OnlyActive Control1 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 TrainingActive Control2 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 OnlyActive Control1 Intervention

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

0 / 5Eligibility criteria met