Smoking Termination Enhancement Project (STEP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier:
NCT01065506
First received: February 8, 2010
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Smoking
Behavioral: Cognitive Behavioral Treatment
Drug: Nicotine Patch
Behavioral: Wellness Program
Behavioral: Aerobic Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Termination Enhancement Project (STEP)

Resource links provided by NLM:


Further study details as provided by Southern Methodist University:

Primary Outcome Measures:
  • Smoking status [ Time Frame: Change from baseline in smoking status at 2, 4, 8, 16, and 24-weeks post Quit Day (week 6) ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065506

Locations
United States, Texas
Southern Methodist University
Dallas, Texas, United States, 75206
Sponsors and Collaborators
Southern Methodist University
Investigators
Principal Investigator: Jasper Smits, PhD Southern Methodist University
Principal Investigator: Michael Zvolensky, PhD University of Houston
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jasper Smits, Ph.D., Principal Investigator, Southern Methodist University
ClinicalTrials.gov Identifier: NCT01065506     History of Changes
Other Study ID Numbers: R01DA027533, 1R01DA027533-01
Study First Received: February 8, 2010
Last Updated: June 14, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 23, 2014