Clinical trial NCT01065506: Smoking Termination Enhancement Project (STEP)
Official title: Smoking Termination Enhancement Project (STEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
timeFrame: End of treatment (10 weeks post quit day) and 30-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Jasper Smits, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Michael Zvolensky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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. doi: 10.1891/0889-8391.25.1.61.
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. doi: 10.1891/0889-8391.25.1.3.
citation: 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.
citation: Smits JA, Zvolensky MJ, Davis ML, Rosenfield D, Marcus BH, Church TS, Powers MB, Frierson GM, Otto MW, Hopkins LB, Brown RA, Baird SO. The Efficacy of Vigorous-Intensity Exercise as an Aid to Smoking Cessation in Adults With High Anxiety Sensitivity: A Randomized Controlled Trial. Psychosom Med. 2016 Apr;78(3):354-64. doi: 10.1097/PSY.0000000000000264.
citation: Smits JA, Zvolensky MJ, Rosenfield D, Marcus BH, Church TS, Frierson GM, Powers MB, Otto MW, Davis ML, DeBoer LB, Briceno NF. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial. Trials. 2012 Nov 13;13:207. doi: 10.1186/1745-6215-13-207.