NCT03912194 · University of Alabama at Birmingham
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
What this study is about
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 effectiveness and mechanisms of change of a novel smoking cessation intervention.
View original scientific description
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.
Interventions
BEHAVIORAL
cognitive-behavioral withdrawal regulation strategies
Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
BEHAVIORAL
relaxation strategies
Participants will generate and refine relaxation techniques with the aid of a therapist
BEHAVIORAL
early withdrawal exposure
Exposure to the first 4 hours of abstinence across 4 separate sessions
Primary outcome measures
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Time frame: 1 month after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Time frame: 3 months after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Time frame: 6 months after end-of-treatment
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- at least 18 years of age
- smoke at least 5 cigarettes per day
- Expired breath carbon monoxide (CO) reading of at least five parts per million
- report the intention to quit
- reside in the Birmingham area with no plan to relocate outside of the area in the next 6 months
- access to a telephone
Exclusion criteria
- inability to speak English
- presence of a condition that contraindicates use of the nicotine patch
- presence of conditions that might interfere with compliance with the protocol or greatly complicate treatment
- any acutely life-threatening disease
- concurrent participation in a formal treatment program for smoking cessation
- current use of any pharmacotherapy for smoking cessation
Where
- Birmingham, Alabama
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations