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Smoking Termination Enhancement Project (STEP) (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01065506
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Cognitive Behavioral Treatment Drug: Nicotine Patch Behavioral: Wellness Program Behavioral: Aerobic Exercise Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Termination Enhancement Project (STEP)
Study Start Date : September 2009
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Standard Care plus Wellness Program Behavioral: Cognitive Behavioral Treatment
Cognitive Behavioral Treatment
Drug: Nicotine Patch
Nicotine Patch
Behavioral: Wellness Program
Wellness Program
Active Comparator: Standard Care plus Exercise Program Behavioral: Cognitive Behavioral Treatment
Cognitive Behavioral Treatment
Drug: Nicotine Patch
Nicotine Patch
Behavioral: Aerobic Exercise
Aerobic Exercise

Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Aged between 18 and 65 years old
  2. Capable of providing informed consent, attend all study visits and comply with the protocol
  3. Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
  4. Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
  5. Score of 20 or greater on 16-item Anxiety Sensitivity Index
  6. 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:

  1. Use of other tobacco products
  2. General medical condition(s) that contraindicate exercise
  3. Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
  4. 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)
  5. Body mass index ≥40
  6. Currently suicidal or high suicide risk
  7. 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
  8. Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
  9. Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
  10. 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
  11. Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065506

United States, Texas
Southern Methodist University
Dallas, Texas, United States, 75206
Sponsors and Collaborators
Southern Methodist University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jasper Smits, PhD Southern Methodist University
Principal Investigator: Michael Zvolensky, PhD University of Houston
More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jasper Smits, Ph.D., Principal Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01065506     History of Changes
Other Study ID Numbers: R01DA027533 ( U.S. NIH Grant/Contract )
1R01DA027533-01 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2010    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action