Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • cognitive-behavioral withdrawal regulation strategies

    Behavioral

    Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist

  • relaxation strategies

    Behavioral

    Participants will generate and refine relaxation techniques with the aid of a therapist

  • early withdrawal exposure

    Behavioral

    Exposure to the first 4 hours of abstinence across 4 separate sessions

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Early Withdrawal Exposure plus NAW Regulation TrainingExperimental treatment 2 interventions
Group B: Early Withdrawal Exposure plus Relaxation Control TrainingActive comparator 2 interventions
Group C: NAW Regulation Training OnlyActive comparator 1 intervention
Group D: Relaxation Control Training OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
1 month after end-of-treatment
2

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

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

Time frame
3 months after end-of-treatment
3

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

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

Time frame
6 months after end-of-treatment

Secondary outcomes

1

Cessation milestones as determined by the Timeline Followback Interview

1\) Was initial abstinence achieved (was there any day of non-smoking within the first two weeks after the quit date; yes or no)?; 2) latency to lapse (number of days to the first cigarette after the quit day); 3) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

Time frame
1 month after end-of-treatment
2

Cessation milestones as determined by the Timeline Followback Interview

1\) latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

Time frame
3 months after end-of-treatment
3

Cessation milestones as determined by the Timeline Followback Interview

1\) latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?

Time frame
6 months after end-of-treatment
4

Physical tobacco dependence

Tobacco dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD). The FTCD is a widely used 9-item measure of physical dependence. FTCD scores, computed from the sum of the items, range from 0 to 10, with greater scores indicating greater dependence.

Time frame
1 month after end-of-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator