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Completed

NCT Number: NCT01065506

Smoking Termination Enhancement Project (STEP)

The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Methodist University

Dallas, Texas, 75206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 65 years old
  • Capable of providing informed consent, attend all study visits and comply with the protocol
  • Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
  • Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
  • Score of 20 or greater on 16-item Anxiety Sensitivity Index
  • Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)

Exclusion criteria

  • Use of other tobacco products
  • General medical condition(s) that contraindicate exercise
  • Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
  • Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
  • Body mass index ≥40
  • Currently suicidal or high suicide risk
  • Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
  • Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
  • Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
  • Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy
  • Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.

Treatment and study plan

Cognitive Behavioral Treatment

Behavioral

Cognitive Behavioral Treatment

Nicotine patch

Drug

Nicotine Patch

Wellness Program

Behavioral

Wellness Program

Aerobic Exercise

Behavioral

Aerobic Exercise

Primary outcomes

  1. Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day

    Time frame: End of treatment (10 weeks post quit day) and 30-week follow-up

    Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up

Sponsors and collaborators

Lead sponsor

Southern Methodist University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: STEP

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2010
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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