Smoking Termination Enhancement Project (STEP)

• Sponsor: Southern Methodist University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01065506
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 3.2

Study Details

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
• 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: Sep 1, 2009
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 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 [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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, 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.
• 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.
• 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.
• 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.

• Responsible Party: Jasper Smits, Ph.D., Principal Investigator, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT01065506
• Other Study ID Numbers: R01DA027533; 1R01DA027533-01
• First Posted: Feb 9, 2010
• Last Update Posted: Feb 4, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Pre-assignment Detail	Of the 150 enrolled participants, 7 participants completed a baseline assessment, then subsequently dropped out of the study before receiving any treatment. 7 participants were used as pilots. Accordingly, results are reported for the remaining 136 participants.

Arm/Group Title	Standard Care Plus Wellness Program	Standard Care Plus Exercise Program
Arm/Group Description	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)
Period Title: Overall Study
STARTED	64	72
End of Treatment	44	37
4-Month Follow-Up	35	34
COMPLETED	32	34
NOT COMPLETED	32	38

Baseline Characteristics

Arm/Group Title	Standard Care Plus Wellness Program	Standard Care Plus Exercise Program	Total
Arm/Group Description	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise	Total of all reporting groups
Overall Participants	64	72	136
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.39 (11.30)	43.12 (11.26)	44.19 (11.29)
Sex: Female, Male (Count of Participants)
Female	36 56.3%	36 50%	72 52.9%
Male	28 43.8%	36 50%	64 47.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.1%	1 1.4%	3 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 15.6%	18 25%	28 20.6%
White	49 76.6%	51 70.8%	100 73.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 4.7%	2 2.8%	5 3.7%
Region of Enrollment (participants) [Number]
United States	64 100%	72 100%	136 100%
ASI-3 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.63 (10.36)	18.04 (12.72)	18.32 (11.62)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the end of treatment assessment

Arm/Group Title	Standard Care Plus Wellness Program	Standard Care Plus Exercise Program
Arm/Group Description	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise
Measure Participants	44	37
End of treatment	5 7.8%	9 12.5%
Follow-up (n=35, 34)	4 6.3%	9 12.5%

Adverse Events

Arm/Group Title	Standard Care Plus Wellness Program		Standard Care Plus Exercise Program
Arm/Group Description	Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Wellness Program: Wellness Program		Cognitive Behavioral Treatment: Cognitive Behavioral Treatment Nicotine Patch: Nicotine Patch Aerobic Exercise: Aerobic Exercise
All Cause Mortality
	Standard Care Plus Wellness Program		Standard Care Plus Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care Plus Wellness Program		Standard Care Plus Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/64 (1.6%)		1/72 (1.4%)
Musculoskeletal and connective tissue disorders
Vertebrae fractures	1/64 (1.6%)	1	0/72 (0%)	0
Skin and subcutaneous tissue disorders
Malignant melanoma	0/64 (0%)	0	1/72 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Standard Care Plus Wellness Program		Standard Care Plus Exercise Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/72 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.