Smoking Termination Enhancement Project (STEP)
This study is ongoing, but not recruiting participants.
Sponsor:
Southern Methodist University
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
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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:
- 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.
Contacts and Locations
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
Additional Information:
Description 
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 |
Additional relevant MeSH terms:
|
Smoking Habits Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013