Smoking Termination Enhancement Project (STEP) (STEP)

• ClinicalTrials.gov Identifier: NCT01065506
• Recruitment Status: Completed
• First Posted: February 9, 2010
• Results First Posted: February 4, 2016
• Last Update Posted: February 4, 2016
• Sponsor: Southern Methodist University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Jasper Smits, Ph.D., University of Texas at Austin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking	Behavioral: Cognitive Behavioral Treatment; Drug: Nicotine Patch; Behavioral: Wellness Program; Behavioral: Aerobic Exercise	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Smoking Termination Enhancement Project (STEP)
• Study Start Date: September 2009
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day [ Time Frame: End of treatment (10 weeks post quit day) and 30-week follow-up ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Texas

Southern Methodist University

Dallas, Texas, United States, 75206

Sponsors and Collaborators

Southern Methodist University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Jasper Smits, PhD; Southern Methodist University
• Principal Investigator: Michael Zvolensky, PhD; University of Houston

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Jasper Smits, Ph.D., Principal Investigator, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT01065506
• Other Study ID Numbers: R01DA027533 ( U.S. NIH Grant/Contract ); 1R01DA027533-01 ( U.S. NIH Grant/Contract )
• First Posted: February 9, 2010
• Results First Posted: February 4, 2016
• Last Update Posted: February 4, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action