Smoking Termination Enhancement Project (STEP)



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:September 2009
End Date:August 2013

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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.


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.
We found this trial at
1
site
Dallas, Texas 75206
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from
Dallas, TX
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