Smoking Termination Enhancement Project (STEP)

Smoking Clinical Trial

— STEP  

Official title:

Smoking Termination Enhancement Project (STEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065506
• Other study ID #: R01DA027533
• Secondary ID: 1R01DA027533-01
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: January 4, 2016
• Start date: September 2009
• Est. completion date: August 2013

Study information

• Verified date: January 2016
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Cognitive Behavioral Treatment
Cognitive Behavioral Treatment

Drug:
• Nicotine Patch
Nicotine Patch

Behavioral:
• Wellness Program
Wellness Program
• Aerobic Exercise
Aerobic Exercise

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southern Methodist University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Deboer LB, Tart CD, Presnell KE, Powers MB, Baldwin AS, Smits JA. Physical activity as a moderator of the association between anxiety sensitivity and binge eating. Eat Behav. 2012 Aug;13(3):194-201. doi: 10.1016/j.eatbeh.2012.01.009. Epub 2012 Jan 28. — View Citation

Mathew AR, Norton PJ, Zvolensky MJ, Buckner JD, Smits JA. Smoking Behavior and Alcohol Consumption in Individuals With Panic Attacks. J Cogn Psychother. 2011 Feb 1;25(1):61-70. — View Citation

Medina JL, Vujanovic AA, Smits JA, Irons JG, Zvolensky MJ, Bonn-Miller MO. Exercise and coping-oriented alcohol use among a trauma-exposed sample. Addict Behav. 2011 Mar;36(3):274-7. doi: 10.1016/j.addbeh.2010.11.008. Epub 2010 Nov 10. — View Citation

Smits JA, Bonn-Miller MO, Tart CD, Irons JG, Zvolensky MJ. Anxiety sensitivity as a mediator of the relationship between moderate-intensity exercise and coping-oriented marijuana use motives. Am J Addict. 2011 Mar-Apr;20(2):113-9. doi: 10.1111/j.1521-0391.2010.00115.x. Epub 2011 Feb 1. — View Citation

Smits JA, Rosenfield D, Mather AA, Tart CD, Henriksen C, Sareen J. Psychotropic medication use mediates the relationship between mood and anxiety disorders and obesity: findings from a nationally representative sample. J Psychiatr Res. 2010 Nov;44(15):1010-6. doi: 10.1016/j.jpsychires.2010.04.007. — View Citation

Smits JA, Tart CD, Rosenfield D, Zvolensky MJ. The interplay between physical activity and anxiety sensitivity in fearful responding to carbon dioxide challenge. Psychosom Med. 2011 Jul-Aug;73(6):498-503. doi: 10.1097/PSY.0b013e3182223b28. Epub 2011 Jun 23. — View Citation

Tart CD, Leyro TM, Richter A, Zvolensky MJ, Rosenfield D, Smits JA. Negative affect as a mediator of the relationship between vigorous-intensity exercise and smoking. Addict Behav. 2010 Jun;35(6):580-5. doi: 10.1016/j.addbeh.2010.01.009. Epub 2010 Feb 1. — View Citation

Zvolensky MJ, Buckner JD, Norton PJ, Smits JA. Anxiety, Substance Use, and Their Co-Occurrence: Advances in Clinical Science. J Cogn Psychother. 2011;25(1):3-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day	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	End of treatment (10 weeks post quit day) and 30-week follow-up	No