Actively Recruiting
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Led by University of Alabama at Birmingham · Updated on 2026-03-11
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a novel smoking cessation intervention aimed at adult smokers who consume at least 5 cigarettes per day and intend to quit. The study focuses on addressing negative affect withdrawal (NAW) symptoms, such as anger, anxiety, and sadness, which contribute strongly to smoking relapse. This Phase 3 trial explores whether combining early withdrawal exposure with NAW regulation training can improve abstinence rates compared to relaxation training or no exposure. Participants will be randomly assigned to one of four groups: early withdrawal exposure plus NAW regulation training, early withdrawal exposure plus relaxation training, NAW regulation training only, or relaxation training only. The interventions involve practicing individualized behavioral strategies or relaxation techniques across four sessions, either during the first 4 hours of smoking abstinence or while smoking as usual. The study uses a factorial design to evaluate the effects and interaction of these components. Throughout the study, participants will undergo regular assessments including self-reported and biochemical confirmation of smoking abstinence at 1, 3, and 6 months after treatment ends. Additional measures include tobacco dependence levels, withdrawal symptoms, abstinence-related thoughts, and motivational factors. The study involves telephone access and residence stability monitoring over 6 months to support follow-up and data collection, aiming to identify effective strategies to enhance smoking cessation outcomes.
CONDITIONS
Brief Title
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Smoking at least 5 cigarettes per day
- Expired breath carbon monoxide reading of at least 5 parts per million
- Intention to quit smoking
- Reside in the Birmingham area with no plans to relocate within 6 months
- Access to a telephone
You will not qualify if you...
- Inability to speak English
- Conditions that contraindicate use of the nicotine patch
- Conditions that interfere with protocol compliance or complicate treatment
- Any acutely life-threatening disease
- Participation in another formal smoking cessation program
- Current use of any smoking cessation medication or pharmacotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 sessions over several weeks
Participants undergo four sessions involving either early withdrawal exposure combined with behavioral withdrawal regulation or relaxation strategies, or one of these interventions alone without withdrawal exposure. These sessions focus on developing and practicing strategies to manage withdrawal symptoms or relaxation techniques.
4 in-person sessions
Duration - 6 months after treatment ends
Participants are monitored for smoking cessation outcomes and withdrawal-related symptoms at 1, 3, and 6 months after the end of treatment.
3 follow-up visits at 1, 3, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Ryals Public Health Building
Birmingham, Alabama, United States, 35294
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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